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How to Conduct Clinical Performance Evaluation for IVDs in India

Thu, 02 Apr 2026 11:59:45 GMT

Clinical performance evaluation for IVDs ensures that in vitro diagnostic devices introduced into the Indian market provide accurate, reliable, and clinically meaningful results. Manufacturers can demonstrate the diagnostic value of their products while supporting patient safety and effective disease detection by following the regulatory requirements established under Medical Device Rules, 2017, and generating robust clinical evidence.

Clinical Performance Evaluation For IVDs

In vitro diagnostic devices (IVDs) play a crucial role in disease detection, screening, and monitoring. In India, many IVDs must undergo clinical performance evaluation before regulatory approval for marketing to ensure their safety, reliability, and clinical utility.

This article explains the regulatory framework, steps, and best practices for conducting IVD clinical performance evaluation in India

Regulatory Framework for IVD Clinical Performance Evaluation

In India, IVDs are regulated as Medical Devices under the Drugs and Cosmetics Act and the Medical Devices Rules (MDR), 2017. The Central Licensing Authority (CLA), operating under the Central Drugs Standard Control Organisation (CDSCO), is responsible for approving clinical performance studies for new IVDs.

The purpose of IVD clinical performance evaluation studies is to establish or confirm that the device performs as intended when tested on humans, particularly in situations where this cannot be adequately demonstrated using analytical performance data, published literature, or evidence derived from routine diagnostic use. The study design may be interventional, observational, or a combination, depending on whether study protocol requires patient management based on test results. The studies assess parameters such as diagnostic sensitivity, specificity, accuracy, and reproducibility.

CDSCO IVD clinical trials require manufacturers to submit a performance evaluation report (PER) that compiles clinical evidence supporting the device’s intended use.

When Is Clinical Performance Evaluation Of In Vitro Diagnostic Kits Required?

Under MDR, 2017, clinical performance evaluation is typically required for higher-risk IVDs, especially:

Class B, C, and D IVDs without predicate devices
Novel diagnostic technologies
Devices claiming new clinical indications

Note: For low-risk Class A IVDs, clinical performance evaluation of IVD may not be required unless deemed necessary by the CLA based on the nature of the IVD. The reasons for this decision should be recorded in writing. Examples of devices in this category include specimen receptacles and simple clinical chemistry analysers that can perform routine assays like glucose measurement.

Clinical Performance Evaluation Process for IVDs in India

The performance evaluation process involves several regulatory and scientific steps to ensure the diagnostic accuracy, safety, and reliability of the device before it is approved for marketing.

Figure1

Development of a Clinical Performance Evaluation Plan

The first step is the preparation of a clinical performance evaluation plan. This document outlines the purpose of the study, along with the scientific, technical, and medical grounds for conducting the evaluation, and clearly defines the scope of the performance assessment.

Regulatory Application to CDSCO

Before initiating the study, the sponsor must obtain permission from the CLA under CDSCO.

As per the MDR, 2017, an application to conduct a clinical performance evaluation of a new IVD must be submitted to the CLA in Form MD-24 IVD application by the sponsor, along with the prescribed fee specified in the Second Schedule and the required supporting information. After reviewing the submitted documents, CDSCO may grant approval in Form MD-25, allowing the sponsor to initiate the study.

Ethics Committee Approval and Trial Registration

Ethical oversight is mandatory for all clinical performance studies involving human specimens. The study protocol must be approved by a registered ethics committee before patient samples are collected.

Additionally, the study must be registered in the Clinical Trials Registry of India (CTRI) prior to enrolment of the first participant. This registration ensures transparency and allows public access to key details about the clinical investigation.

Conduct of the Clinical Performance Study of IVD

Once IVD regulatory compliance in India is obtained, the clinical performance study can begin. These studies must be conducted in accordance with:

Good Clinical Practice (GCP) guidelines
Approved study protocol
Requirements under MDR, 2017

Clinical performance studies assess the diagnostic accuracy of an IVD by comparing its results with a reference standard method. Several parameters are used to assess the clinical performance of the device (Table 1).These parameters collectively help determine whether the diagnostic device provides reliable and clinically meaningful results for its intended use.

Additional assessments, such as reproducibility, cross-reactivity, and interference testing, may also be performed depending on the type of IVD diagnostic device study in India

Parameter	Definition
Diagnostic Sensitivity	The ability of a diagnostic device to correctly identify a target marker for a condition (expressed as a percentage of individuals with the target disease who test positive).
Diagnostic Specificity	The ability of a diagnostic device to correctly identify the absence of a target marker of a specific condition (expressed as a percentage of individuals who do not have the target disease or condition who test negative).
Positive Predictive Value (PPV)	The ability of the device to identify the proportion of individuals with true positive results who truly have the disease.
Negative Predictive Value (NPV)	The ability of the device to identify the proportion of individuals with true negative results who truly do not have the disease.
Likelihood Ratio	The likelihood of getting a test result in a person with a target health condition compared to the likelihood of getting the same result in a person without the target health condition.

Table 1: Key clinical performance parameters

Data Analysis and PER

After completion of the clinical performance study, the collected data are statistically analysed to determine whether the device meets predefined performance criteria. The findings are compiled into a PER.

Typically, the PER includes key information such as the product name, batch or lot number, manufacturer and importer details, number of samples tested, testing principle, reference method used, and testing procedure.

The report also summarises important performance indicators, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), repeatability, reproducibility, and accuracy, along with the report number, date of analysis, and signatures of the analyst and authorised laboratory signatory.

Regulatory Submission and Approval

The final PER, along with other technical and quality documentation, is submitted to CDSCO as part of the device licensing application.

Regulators review the evidence to confirm that the device demonstrates adequate clinical performance, reliability, and safety for its intended diagnostic use. If the evidence is satisfactory, the device may be granted approval for marketing in India.

Conclusion

Clinical performance evaluation of IVD is a critical step in demonstrating the safety, accuracy, and clinical utility of IVDs in India. The process spans from developing a clinical performance evaluation plan to conducting the study and compiling a PER to ensure that the diagnostic device performs reliably in real clinical settings.

Manufacturers can generate credible clinical evidence supporting the intended use of their diagnostic devices by adhering to the requirements established by CDSCO. This structured evaluation process ultimately supports the clinical validation of IVD diagnostic tests, ensuring that only accurate and reliable diagnostics are introduced into the Indian healthcare system.

References

Ramesh M, Sah H, C A. Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives. J Appl Lab Med 2026;11(1):125-142. doi:10.1093/jalm/jfaf164
Medical Devices Rules, 2017.pdf. Accessed March 12, 2026. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules,%202017.pdf
Leeflang MMG, Allerberger F. How to: evaluate a diagnostic test. Clin Microbiol Infect. 2019;25(1):54-59. doi:10.1016/j.cmi.2018.06.011
GHTF SG5 Clinical Performance Studies for IVD Medical Devices. Accessed March 24, 2026. https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n8-2012-clinical-performance-studies-ivd-medical-devices-121102.pdf
Manu M, Anand G. A review of medical device regulations in India, comparison with European Union and way-ahead. Perspect Clin Res. 2022;13(1):3-11. doi:10.4103/picr.PICR_222_20
CDSCO-IVD-FAQ-03-2022-.pdf. Accessed March 12, 2026. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/IVD/FAQs/CDSCO-IVD-FAQ-03-2022-.pdf
FAaddendum.pdf. Accessed March 12, 2026. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/FAaddendum.pdf

Regulatory Strategy for Biological & Vaccine Clinical Trials in India

Thu, 02 Apr 2026 11:59:31 GMT

Conducting biologics, biosimilar, and vaccine clinical trials in India requires careful alignment with regulatory requirements throughout the development lifecycle. Sponsors must generate robust preclinical data, obtain regulatory approvals through the Central Drugs Standard Control Organization (CDSCO), and conduct phased clinical trials to demonstrate safety, immunogenicity, and efficacy. While challenges such as variability in immune responses, manufacturing complexity, and distribution logistics remain, strategic regulatory planning and strong safety monitoring systems can help ensure the successful development and timely availability of vaccines and biological therapies for public health.

A Guide to Biosimilar Regulatory Strategy & Vaccine Clinical Trials in India

Biological products and vaccines play a critical role in preventing and treating infectious and chronic diseases. However, due to their complex manufacturing processes, immunogenicity concerns, and safety considerations, their clinical development requires a carefully designed regulatory strategy. In India, clinical trials for biologics and vaccines are governed by a structured regulatory framework that ensures safety, efficacy, and quality before market approval.

This article helps sponsors understand regulatory requirements early in biological clinical trials in India, enabling them to design efficient clinical programs, avoid delays, and ensure compliance with national guidelines.

Regulatory Framework Governing Biologicals and Vaccine Clinical Studies in India

The regulatory oversight for drugs, biologics, and vaccines in India is primarily handled by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940, and its associated rules.

Clinical trials are regulated through the New Drugs and Clinical Trials Rules (NDCTR), 2019, which provide a unified framework for new drug approvals, trial permissions, and post-approval monitoring in India.3 Therefore, under the NDCT Rules, biologicals and vaccines must undergo a structured clinical development process before receiving regulatory approval in India.

The final authority responsible for approving clinical trials is the Drugs Controller General of India (DCGI).

These regulations apply to several categories of biological products, including

Vaccines
Recombinant biologics
Monoclonal antibodies
Gene and cell therapies

Key Stages in Regulatory Strategy for Biological & Vaccine Trials

Developing a regulatory strategy for biologicals and vaccine clinical trials approval in India requires planning across the full development lifecycle and includes the following stages:

Preclinical Development

Before human testing begins, sponsors must generate robust preclinical data. Key requirements include:

Toxicology studies
Immunogenicity evaluation
Pharmacodynamic and pharmacokinetic assessments
Proof-of-concept animal studies

These studies demonstrate the safety profile and justify initiating human trials.

Vaccine or Biological Clinical Trial Application Submission

Sponsors must submit a clinical trial application to obtain regulatory approval from CDSCO before conducting human clinical trials.
For this, they need to submit a clinical trial application (Form CT-04) to CDSCO’s Biological Division
through the SUGAM portal. The application typically includes:

Clinical trial protocol
Investigator’s brochure
Chemistry, manufacturing, and controls (CMC) data
Preclinical safety data
Ethics committee approvals
Informed consent documents

After a biological / vaccine clinical trial application submission in India, the application undergoes regulatory review and may be evaluated by the relevant Subject Expert Committee.

Conduct of Biological Clinical Trial Phases

Biologics and vaccines generally follow a stepwise clinical development pathway, where each phase is designed to progressively evaluate safety, immunogenicity, efficacy, and manufacturing readiness before widespread use.

Phase I

Phase I trials are conducted in a small group of healthy volunteers or patients and typically involve initial dose-escalation studies. The expected outcomes from this phase include the generation of data on safety, immunogenicity, dose-escalation, efficacy, manufacturing process, and human study design approvals.

Phase III

Phase III trials are large-scale studies designed to confirm the safety and efficacy of the product. The expected outcomes from the proposed India Phase III include safety and efficacy data, emergency use licensure, lot release, rollout planning, serious adverse event monitoring, cluster randomised control monitoring, and eventual full market authorisation.

Note: For vaccines, clinical endpoints often include disease prevention or validated immunological correlates of protection.

Regulatory Review and Marketing Authorisation

After successful clinical trials, sponsors submit a New Drug Application (NDA) to CDSCO. The submission includes:8

Complete clinical trial data
Safety and immunogenicity data
Manufacturing validation
Quality and stability information

CDSCO reviews the data and may grant marketing approval if the product meets safety, efficacy, and quality requirements.

Post-Marketing Surveillance

Even after approval, vaccines and biologicals require continued monitoring. Post-marketing obligations may include:9

Periodic safety update reports (PSUR)
Risk management plans
Pharmacovigilance reporting
Post-authorisation studies

India has strengthened vaccine pharmacovigilance requirements to monitor adverse events following immunisation and ensure long-term safety.

Challenges in Conducting Vaccine Trials in India

Despite significant progress in vaccine research and immunisation programs, vaccine development and deployment remain complex. Biological variability, regulatory considerations, manufacturing constraints, and infrastructure limitations all influence vaccine clinical development and rollout in India. The key challenges are summarised in Table 1.1

Challenge	Key Issues
Biological variability	Vaccine responses vary across individuals due to age, gender, genetics, lifestyle, and immune status. Infants and older adults (>60 years) often show weaker or different immune responses, and underlying conditions such as diabetes or cancer may also influence vaccine effectiveness.
Variability in immune responses	Immune responses can differ widely among populations, especially in elderly individuals with comorbidities. Some vaccines may also show differences in effectiveness based on genetic variations or immune memory.
Manufacturing limitations	Vaccine production involves complex processes and strict quality control, resulting in a limited number of manufacturers capable of producing vaccines at scale.
Cost and affordability	Vaccine development and manufacturing are expensive, which historically limited access in developing countries, although affordability has improved in recent years.
Vaccine hesitancy and public acceptance	Public scepticism toward vaccines remains a global concern. Vaccine acceptance influences the success of mass immunisation campaigns and the ability to achieve herd immunity.
Global supply and distribution	Ensuring sufficient vaccine supply worldwide is challenging, especially during pandemics. Past outbreaks have shown that wealthier countries may secure a large portion of available vaccine supplies.
Infrastructure challenges in India	Delivering vaccines across India’s large and diverse population can be difficult due to limited laboratory facilities, high costs, inadequate cold chain infrastructure, and transportation challenges.

Short Summary

Biologicals and vaccines require a well-planned regulatory strategy due to their complex manufacturing processes and safety considerations.
In India, clinical trials are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials Rules (NDCTR), 2019.
Clinical development follows a stepwise pathway including preclinical studies, clinical trial application submission, and phased clinical trials (Phase I to III).
Each clinical phase generates critical evidence on safety, immunogenicity, efficacy, dose optimisation, and manufacturing readiness.
After successful trials, sponsors submit a New Drug Application (NDA) for regulatory review and marketing authorisation.
Vaccine development and deployment in India face challenges related to biological variability, manufacturing capacity, cost, vaccine hesitancy, and infrastructure limitations.

Conclusion

Developing biologicals and vaccines requires a well-structured regulatory strategy that aligns scientific development with regulatory expectations. In India, clinical trials for biologics and vaccines are governed by a defined framework involving regulatory oversight, ethical review, and structured clinical development phases to ensure safety, efficacy, and quality before market authorisation.

Each stage of clinical development in India, from early safety and immunogenicity assessment to large-scale efficacy trials and eventual licensure, plays a critical role in generating the evidence required for regulatory approval and public health deployment. However, vaccine development is influenced by several challenges, including variability in immune responses, manufacturing complexity, cost considerations, vaccine hesitancy, and logistical barriers in large and diverse populations.

Despite these challenges, India continues to strengthen its regulatory environment and clinical research infrastructure. Sponsors can successfully navigate the development pathway and support the timely availability of safe and effective biologicals and vaccines for public health needs with strategic planning, early regulatory engagement, and strong safety monitoring systems.

References

Salalli R, Dange JR, Dhiman S, Sharma T. Vaccines development in India: advances, regulation, and challenges. Clin Exp Vaccine Res. 2023;12(3):193-208. doi:10.7774/cevr.2023.12.3.193
2016DrugsandCosmeticsAct1940Rules1945.pdf. Accessed March 12, 2026. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf
NEW DRUGS AND CTRS RULE, 2019.pdf. Accessed March 12, 2026. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/new_DC_rules/NEW%20DRUGS%20ANDctrS%20RULE,%202019.pdf
Clinical Research Regulation For India | ClinRegs. Accessed March 12, 2026. https://clinregs.niaid.nih.gov/country/india#
Shen J, Swift B, Mamelok R, Pine S, Sinclair J, Attar M. Design and Conduct Considerations for First‐in‐Human Trials. Clin Transl Sci. 2019;12(1):6-19. doi:10.1111/cts.12582
CDSCO – Revised Guidance for Industry – Stakeholders Comments Website.pdf. Accessed March 12, 2026. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/CDSCO%20-%20Revised%20Guidance%20for%20Industry%20-%20Stakeholders%20Comments%20Website.pdf
Dinda AK, Tripathi SK, John B. Revisiting regulatory framework in India for accelerated vaccine development in pandemics with an evidence-based fast-tracking strategy. Indian J Med Res. 2020;152(1-2):156-163. doi:10.4103/ijmr.IJMR_3640_20
Update_Checklist_10July2018.pdf. Accessed March 13, 2026. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/New-Drugs/Checklist/Update_Checklist_10July2018.pdf
Draft Guidance for pvpi.pdf. Accessed March 13, 2026. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Draft%20Guidance%20for%20pvpi.pdf

How to Get CDSCO Approval for Medical Device Clinical Investigations in India

Tue, 31 Mar 2026 14:16:14 GMT

In India, Medical Devices must meet established safety and quality standards before they can be used in healthcare. The approval process for Medical Device clinical investigation involves a regulated process that includes development, testing, clinical investigation, and review by the Central Licensing Authority. Understanding this process is important for manufacturers and sponsors seeking to introduce new devices in the country.

Medical Devices in India

Medical Devices are an essential part of the healthcare system in India and contribute significantly to improving patient care. They are commonly used for purposes such as screening, diagnosis, treatment, and monitoring of health conditions.

According to the Indian Medical Devices Rules (IMDR), 2017, Medical Devices include:

Products used for in vitro diagnostic (IVD) purposes, surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, and blood or blood component collection bags with or without anticoagulants.
Substances such as mechanical contraceptives, including condoms, intrauterine devices, and tubal rings, as well as disinfectants and insecticides used for medical purposes.
Devices that are notified under sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940.

India is considered one of the top 20 Medical Device markets globally, reflecting the increasing demand for healthcare technologies. However, domestic production is still limited, and nearly 70% of Medical Devices used in the country are imported. To introduce new devices safely, manufacturers must obtain Central Drugs Standard Control Organization (CDSCO) approval in India, ensuring that investigational devices meet regulatory standards for safety, quality, and performance.

Regulatory Framework for Medical Devices Clinical Investigation in India

In India, the regulation of Medical Devices is mainly carried out by the CDSCO under the Ministry of Health and Family Welfare. Earlier, there were no separate regulations for Medical Devices, and only a few notified devices were regulated under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.

To address this gap, IMDR 2017 were introduced and later strengthened through the Medical Devices (Amendment) Rules, 2020.

Major regulatory functions of CDSCO include:

Granting registration certificates to notified bodies for auditing Class C and D.
Issuing import licenses for Medical Devices.
Granting manufacturing licenses.
Providing test licenses and overseeing IVD clinical trial regulations in India.
Granting permission to conduct clinical investigations.

These activities help ensure that Medical Devices in India meet the required safety and quality standards.

Classification of Medical Devices

In India, Medical Devices are classified under IMDR 2017 based on the level of risk associated with the device and its intended use.1 This classification helps regulatory authorities determine the level of regulatory oversight required for different types of Medical Devices.

Table 1: Risk-Based Classification of Medical Device Clinical Evaluation in India

Class	Risk Level to Patient
Class A	Low risk
Class B	Low-to-moderate risk
Class C	Moderate-to-high risk
Class D	High risk

Risk classification of Medical Devices is based on their intended use, such as non-invasive devices, invasive devices, surgically invasive devices, and other specialized categories. Generally, the State Licensing Authority regulates Class A and Class B devices, while Class C and Class D devices are regulated by the Central licensing authority.

Approval Pathway Of Medical Device Clinical Performance Evaluation in India

The approval of Medical Devices in India follows a structured regulatory process under IMDR 2017. The CDSCO Medical Device clinical investigation in India framework ensures that devices meet the required standards of safety, quality, and performance before they are marketed. The pathway generally begins with the development of the device and continues through testing, clinical investigation, and regulatory approval.

The major steps involved in the approval pathway include:

Product development/prototype stage, where the investigational device is designed and initially tested.
Obtaining a test license for manufacturing or importing the device for testing (Form MD-12/MD-13 or MD-16/MD-17, respectively).
Clinical investigation approval, where permission to conduct the investigation is applied using MD-22 application India and granted in Form MD-23.
Permission to import or manufacture investigational devices through Form MD-26, with approval granted in Form MD-27.
Manufacturing or import license before commercial marketing.

All applications for these steps must be submitted via the CDSCO SUGAM portal submission, ensuring efficient processing, tracking, and regulatory compliance. These steps help guarantee that Medical Devices are rigorously evaluated before entering India’s healthcare system, supporting safety, quality, and innovation.

CDSCO Approval Process for Clinical Investigation of Medical Devices

Clinical investigation is an important step in the Medical Device approval pathway in India, as it helps generate evidence on the device’s safety, performance, and effectiveness in human subjects. This stage bridges the gap between early device testing and final regulatory approval for market entry. In India, approval for clinical investigations is granted by the Central Licensing Authority (CLA) under CDSCO, and sponsors must follow specific regulatory procedures before initiating studies.

Key steps for obtaining CDSCO approval include the following:

For obtaining a test license:

Submit Form MD-12 to the manufacturer for manufacturing a small quantity of the device for clinical investigation, evaluation, and test on NSWS portal
Pay the required application fee for each Medical Device and submit supporting documents, such as device description, equipment list, manufacturing details, and technical personnel information, to CLA for approval of the above.
The CLA reviews and verifies all submitted information and documents and grants permission for test license if satisfied.

For approval to conduct a clinical investigation:

Sponsors submit Form MD-22 along with required fees and documents to CLA to seek approval to conduct a clinical investigation.
Obtain Ethics Committee approval in India through acceptance of the Clinical Investigation Plan (CIP) by a registered Independent Ethics Committee (IEC).
Clinical investigations should conform to the approved CIP, follow Good Clinical Practice (GCP) guidelines by CDSCO, and should be registered in the Clinical Trial Registry of India (CTRI).

Once the CLA is satisfied with the submitted information and compliance with IMDR 2017 requirements, permission is granted to conduct the clinical investigation. If the authority is not satisfied, the application may be rejected and the reasons recorded in writing.

Figure1

Conclusion

Obtaining CDSCO clinical trial approval in India for Medical Device clinical investigations requires strict adherence to the Medical Devices Rules, 2017. Sponsors and manufacturers must submit the necessary forms, secure test licenses, and comply with Good Clinical Practice (GCP) guidelines. The Central Licensing Authority evaluates each application to ensure the safety, quality, and performance of the investigational device. By completing these steps and maintaining proper documentation, organizations can successfully conduct a Medical Device clinical performance evaluation and support the development of safe, effective devices for India’s healthcare system.

References

A review of Medical Device regulations in India, comparison with European Union and way-ahead – PMC. Accessed March 12, 2026. https://pmc.ncbi.nlm.nih.gov/articles/PMC8815674/#sec1-5
Sharma D, Chandra A. Medical Device Rules – 2017, India: An Insight. ACCTRA. 2020;7(2):126-134. doi:10.2174/2666255813666190912114043
(PDF) A Review on Approval Process and Regulation of Medical Devices as per US FDA and CDSCO. Accessed March 12, 2026. https://www.researchgate.net/publication/370019210_A_Review_on_Approval_Process_and_Regulation_of_Medical_Devices_as_per_US_FDA_and_CDSCO
Maske TR, Ware DN. THE COMPARISON OF MEDICAL DEVICE REGULATIONS IN INDIA WITH USA, EU: AN QUALITATIVE STUDY. 2023;8(3).
PowerPoint Presentation. Accessed March 12, 2026. https://www.cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/RegulatoryMDR-2017.pdf?utm_source=chatgpt.com

Clinical Performance Evaluation of IVDs in India: Regulatory Requirements & Study Design

Tue, 10 Mar 2026 12:57:22 GMT

This article provides an overview of the regulatory framework governing Clinical Performance Evaluation (CPE) of In-Vitro Diagnostic devices (IVDs) in India. It outlines the classification of IVDs, roles of regulatory authorities, approval pathways, and key study design considerations under the Medical Device Rules, 2017, offering practical insights for manufacturers, researchers, and regulatory professionals.

Introduction

In-Vitro Diagnostic (IVD) devices include reagents, kits, instruments, and systems intended for the examination of human specimens such as blood, urine, or tissue outside the human body. They fulfil a vital role in healthcare by generating reliable information to support clinical decision-making, disease diagnosis, screening, monitoring, and prognosis. Additionally, they help in assessing disease predisposition and compatibility for blood transfusion or organ

In India, all IVD kits and reagents are regulated as medical devices under the Medical Device Rules (MDR), 2017.2 These regulations require evidence of safety, analytical performance, and clinical performance prior to market authorisation. In vitro diagnostic Clinical Performance Evaluation (CPE) is therefore a critical regulatory requirement, ensuring that IVDs perform as intended in the target population and clinical setting.3 This article highlights the regulatory framework governing clinical performance evaluation of IVD (India) and key considerations for study design for IVD clinical trial (India).

Regulatory Framework for IVD Clinical Trial in India

The regulatory framework in India ensures that only IVDs meeting defined safety and performance requirements are approved for import, manufacture, and marketing.

The Central Drugs Standard Control Organization (CDSCO) acts as the national regulatory authority responsible for the licensing, oversight, and post-market surveillance of IVDs.
Within CDSCO, the Medical Devices & Diagnostics Division is specifically responsible for the scientific and regulatory review of IVD kits and reagents.
The CDSCO IVD guidelines must be diligently adhered to for timely approvals of IVDs.

IVD Classification and Risk-Based Regulatory Approach

IVD regulatory requirements (India) classify medical devices into Classes A, B, C, and D based on their intended use and the potential risk to patients and public health. This classification determines the level of regulatory oversight and clinical evidence required.

Class A (Low risk): Specimen receptacles and simple routine chemistry devices.
Class B (Low to moderate risk): Devices such as pregnancy test kits and urine strips.
Class C (Moderate to high risk): Devices including genetic testing and PSA kits.
Class D (High risk): Critical diagnostics such as blood grouping and hepatitis B kits.

Regulatory Authorities and Their Jurisdiction

The Central Licensing Authority (CLA) is the competent authority for:

Import of all classes of IVD medical devices.
Manufacture of Class C and Class D IVDs.
Approval and oversight of clinical performance evaluation of new IVDs.
Coordination with State Licensing Authorities (SLAs).

The SLA, headed by the State Drugs Controller, is responsible for:

Manufacture for sale or distribution of Class A and Class B IVDs.
Regulation of the sale, stock, exhibition, and distribution of IVDs across all classes within the state.

IVD Clinical Performance Study (India)

Regulatory Requirements

CPE of any new IVD Medical Device in India requires prior permission from the CLA. No sponsor may conduct CPE using human specimens unless such permission is granted and the evaluation is conducted in accordance with the approved regulatory framework.

Key regulatory requirements for the grant of permission include:

Submission of an application in Form MD-24 to the CLA.
Payment of the prescribed fee (as per the Second Schedule), where applicable.
Submission of supporting documentation as specified in the Seventh Schedule.

Upon review, the CLA may:

Grant permission in Form MD-25, or
Reject the application within 90 days, with reasons recorded in writing.
Abbreviate, defer, or waive CPE requirements in the public interest.

The CPE application dossier must include:

Approval from a registered Ethics Committee.
Details of the sample source and quantity.
Device description, intended use, labelling, and regulatory status in other countries.
In-house performance data (sensitivity, specificity, stability, repeatability, reproducibility).
A clinical performance evaluation plan, case report forms, and the investigator undertakings.
List of participating laboratories or institutions.
A performance evaluation report from a laboratory designated under Rule 19.

The key CDSCO application and approval forms relevant to clinical performance evaluation of IVDs in India are summarised in Table

Regulatory Activity	Application Form	Approval/Licence Form
Manufacture of IVDs for evaluation and CPE (non-commercial)	MD-12	MD-13
Import of IVDs for evaluation and CPE (non-commercial)	MD-16	MD-17
Conduct of clinical performance evaluation of a new IVD	MD-24	MD-25
Import or manufacture of a new IVD for commercial sale	MD-28	MD-29
Registration of IVD testing laboratories	MD-39	MD-40

Study Design

Study design for clinical performance evaluation should be scientifically justified and aligned with the intended use of the device. The following elements are important when planning a CPE study:

Clearly Defined Objectives and Intended Use

Definition of the clinical question and primary performance parameters (e.g., sensitivity, specificity, agreement with a reference method) in relation to the intended use and target population.

Study Design and Methodology

Selection of an appropriate study design based on clinical context and data availability.
Establishment of inclusion and exclusion criteria reflective of the intended use population.

Comparator or Reference Method

Identification and justification of an appropriate comparator or reference standard that is clinically relevant and scientifically validated.

Sample Size and Specimen Selection

Statistical justification of sample size to adequately evaluate performance endpoints.>
Inclusion of representative specimens reflecting clinical variability and intended use settings.

Performance Endpoints and Statistical Analysis

Predefinition of performance endpoints such as sensitivity, specificity, predictive values, agreement, and reproducibility.
Development of a statistical analysis plan detailing analytical methods and confidence interval estimation.

Quality Assurance and Bias Control

Implementation of procedures to minimize bias and ensure data integrity across study sites or laboratories.
Documentation of personnel training, instrument calibration, and quality control measures.

Documentation and Record Keeping

Maintenance of complete records related to study conduct, raw data, deviations, and analysis outputs for regulatory inspection.
Ensuring traceability of specimens, test results, and evaluator decisions.

Conclusion

CMeeting the CDSCO IVD clinical evaluation is a key regulatory requirement for their approval in India post IVD clinical performance study (India). A clear understanding of MDR 2017 requirements, coupled with robust well-designed clinical performance study design for IVD, is essential to demonstrate device safety and performance in IVD clinical trials in India . Additionally, adherence to regulatory expectations and study design practices facilitates timely regulatory approval and ensures reliable diagnostic outcomes in clinical practice.

Short Summary

In-Vitro Diagnostic (IVD) devices are regulated medical devices in India under the Medical Device Rules (MDR), 2017.
Clinical Performance Evaluation (CPE) is a mandatory regulatory requirement to demonstrate that IVDs perform in terms of diagnostic sensitivity, specificity, & usability as intended in the target population.
The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of IVDs, with responsibilities divided between the Central Licensing Authority (CLA) and State Licensing Authorities (SLAs) based on device risk class.
CPE of new IVDs requires prior approval from the CLA and must comply with Good Clinical Practice, Ethics Committee approval, and registration with the Clinical Trials Registry of India.

References

Ramesh, Mahima, Harsh Sah, and Amrutha C. “Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives.” The Journal of Applied Laboratory Medicine11, no. 1 (2026): 125–42. https://doi.org/10.1093/jalm/jfaf164
“FAQ_IVD_MDR-2017_2.Pdf.” n.d. Accessed February 4, 2026.https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/IVD/FAQs/FAQ_IVD_MDR-2017_2.pdf
“Medical Devices Rules, 2017.Pdf.” n.d. Accessed February 4, 2026.>https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules,%202017.pdf
“InVitro Diagnostics.” Accessed February 4, 2026.https://www.cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/InVitro-Diagnostics/

3 Strategies to Improve Clinical Trial Project Outcomes

Thu, 06 Nov 2025 11:22:20 GMT

Short Description

Successful clinical trials focus on achieving defined objectives while safeguarding participants’ well-being by ensuring accurate data collection, regulatory compliance, and effective project management. Implementing strategies such as virtual clinical trials, reframing the study design, and understanding risk management can guide clinical trials toward credible results and meaningful contributions to medical research.

The key strategies that can significantly improve clinical trial project management and outcomes include:

Implementation of Virtual Clinical Trials
Reframing the Study Design (Patient-Centric)
Risk management in Clinical Trials

Strategy	Objective	Benefits of Implementation
Virtual Clinical Trials	Digital, decentralized trials	Better data quality, inclusivity, and convenience
Patient-Centric Study Design	Flexible, inclusive, adaptive design	More relevant outcomes and patient engagement
Risk Management	Identify and mitigate trial risks	Ensures safety, data integrity, and regulatory compliance

Table 1: Three strategies that can help in clinical trial project management and outcomes.

By incorporating virtual trials, adopting patient-centric designs, and strengthening risk management, organizations can achieve more reliable, efficient, and impactful clinical trial outcomes.

Implementation of Virtual Clinical Trials

The implementation of virtual clinical trials represents a transformative shift in how medical research is conducted, with improvements in the quality, inclusivity, and efficacy of clinical trial outcomes.

The advantages and benefits of virtual clinical trials include:

Enabling the direct recruitment of large and diverse participant cohorts, allowing researchers to reach populations that are traditionally underrepresented in conventional, site-based trials.
When embedded within healthcare systems, virtual trials can integrate with electronic health records to capture real-world outcomes efficiently. The use of these designs supports real-time monitoring and data-driven decision-making, enhancing both accuracy and timeliness of outcome assessments.
Direct-to-participant trial designs are particularly valuable for aligning studies with patient preferences—in terms of participation timing, method, and type of research. These designs may advance the science of patient engagement, ensuring that participants are not passive subjects but are actively involved in research.
Virtual trials may also improve ongoing, longitudinal relationships between researchers and participants, enabling continuous learning and generating new hypotheses. The outcomes of these virtual clinical trials may help in defining the populations that should be included, more realistic inclusion / exclusion criteria, and improved retention.
Incorporating virtual clinical trials may help to improve the clinical trial outcomes for enhancing data quality, inclusiveness, and real-world relevance.

Thus, virtual clinical trials may help in clinical trial project management by enhancing comfort, convenience, and confidentiality, addressing long-standing participant concerns about travel, scheduling, and privacy for patients.

Reframing the Study Design (Patient-Centric)

Clinical trials should move beyond single-variable frameworks to more holistic, data-informed, and patient-centered models. This involves using preclinical animal models that accurately simulate human disease to determine the appropriate dosing, duration, and outcome measures before beginning trials on humans.

Studies can be reframed by:

Broadening the inclusion criteria to represent diverse patient populations and manage risk factors prospectively throughout the study, thereby incorporating adherence monitoring, comorbidity control, and lifestyle or behavioral interventions where appropriate.
Ensuring meaningful clinical endpoints, such as survival, quality of life, and functional outcomes, to enhance genuine patient benefit.
Allowing flexible, adaptive, and multimodal trial designs that are capable of evaluating combination therapies and adjusting protocols based on interim data.

Improving the success and clinical relevance of trials requires a comprehensive, integrated approach that addresses the limitations of current study designs. By uniting these strategies, such as translationally accurate preclinical modeling, big data-driven trial design, proactive risk management, inclusive participation, and adaptive methodology, clinical trials can become more predictive, efficient, and ultimately more relevant to improving patient care.

Risk Management in Clinical Trials

Risk management in clinical trials is a systematic process of identifying, assessing, and mitigating potential threats that could impact the safety of participants, data integrity, and overall study outcomes. The goal is to create a proactive framework that ensures the trial progresses smoothly, efficiently, and aesthetically.

The benefits of risk management in clinical trials are substantial. These include:

Enhances patient safety by identifying potential adverse events early and establishing monitoring protocols to address them promptly. This ensures that participants are protected and ethical standards are upheld.
Improves data integrity by reducing the likelihood of errors, missing data, or inconsistencies, which are critical for reliable and scientifically valid outcomes.
Helps maintain project timelines and budget control, as proactive planning and mitigation strategies prevent costly delays and unexpected expenses.

Risk management supports regulatory compliance by demonstrating a structured approach to potential challenges, facilitating smoother audits and inspections. It also allows the trial teams to respond effectively to unforeseen circumstances without compromising study quality. Overall, integrating risk management into clinical trials transforms it into a controlled and manageable process, increasing the likelihood of successful trial completion while maintaining high standards of safety, quality, and efficiency.

How can CliniExperts help?

CliniExperts can help organizations achieve successful clinical trial outcomes by providing end-to-end regulatory and operational support tailored to modern research needs. With expertise in virtual clinical trial implementation, CliniExperts assists sponsors in adopting digital and decentralized models that enhance participant recruitment, engagement, and real-time data collection. By leveraging secure technologies and ensuring compliance with global regulatory standards, CliniExperts enables efficient and patient-friendly trials that maintain high data quality and ethical integrity.

In addition, CliniExperts guides sponsors in developing patient-centric study designs that reflect real-world conditions and diverse populations. By choosing CliniExperts, you can transform your clinical trial project management through innovation, regulatory expertise, and operational excellence, helping organizations bring safe and effective medical treatments.

Conclusion

By implementing virtual clinical trials, adopting patient-centric study designs, and strengthening risk management frameworks, organizations can enhance data quality, operational efficiency, and participant engagement. Moreover, integrating these strategies leads to more reliable results, faster development timelines, and the advancement of safe, effective medical treatments that may benefit patients.

Short Summary

The objectives of a successful clinical trial focus on achieving well-defined scientific and operational goals while ensuring patient safety.
The 3 strategies of clinical trial project management that can help improve project outcomes include: Implementation of virtual clinical trials, reframing the study design (patient-centric), and risk management in clinical trials.
Implementing these strategies allows high-quality data collection, adherence to ethical and regulatory standards, and efficient project management, thereby allowing reliable results and development of safe and effective medical treatments.

Using Drones in ICMR Trials: A New Frontier in Clinical Research Logistics

Wed, 13 Aug 2025 10:59:46 GMT

Short Description

The Indian Council of Medical Research (ICMR), in collaboration with AIIMS and Dr. Shroff’s Charity Eye Hospital, is harnessing drone technology to enhance clinical trial logistics and healthcare delivery. In a recent initiative, drones successfully transported sensitive ophthalmic biomaterials, such as human corneas, from peripheral centres to AIIMS hospitals, reducing transit time from 2.5 hours to just 40 minutes. This timely, temperature-controlled transport preserved tissue viability, enabling successful transplants and improving access to critical care in remote regions.

Why Is ICMR Using Drones in Clinical Trials

The Indian Council of Medical Research (ICMR) is utilizing drone technology in clinical trials to improve healthcare delivery in remote and underserved areas. The use of drones helps drastically reduce the time needed to transport critical medical supplies, especially in emergencies such as trauma care, surgeries, and maternal complications. These trials represent a major step forward in India’s commitment to adopting innovative, tech-driven healthcare solutions. Recognized by health experts and officials as a significant innovation, drone-based delivery aims to overcome challenges like traffic congestion, ambulance delays, and unequal healthcare access. ICMR’s i-DRONE (Drone Response and Outreach for Northeast) platform, initially launched during the COVID-19 pandemic to deliver vaccines, has since expanded to support various healthcare needs across diverse terrains and climates in India.

Fig.1: Benefits of Using Drones in Clinical Trials

How Do Drones Ensure Safety and Sample Integrity

Drones help ensure the safety and integrity of medical samples by offering dependable alternatives to road-based delivery, especially in emergencies and difficult terrains.

In clinical emergencies, drones have shown faster delivery times than ambulances, improving the chance of preserving blood products.

Drones can be equipped with controlled environment systems to transport temperature-sensitive materials like vaccines and serums, ensuring they remain within manufacturer-recommended conditions during transit.

Enabled by Beyond Visual Line of Sight (BVLOS) technology, drones can safely travel longer distances to ensure timely delivery.

Considered a leapfrog innovation, drones can help improve healthcare equity in challenging and underdeveloped regions.

The COVID-19 crisis exposed gaps in medical supply delivery that drones effectively helped to address.

In areas with poor road connectivity, drones are more affordable and efficient than traditional transport methods.

In rural Virginia, drones delivered medical supplies in 30 minutes, saving time (60 minutes) compared to road transport.

Apart from healthcare, small drones are also used to monitor weather and traffic conditions.

This technology has also been applied in disaster management, with the successful delivery of medical supplies in Nepal and Canada during emergencies.

What Types of Drones Are Used in Healthcare in India and Globally?

In India and globally, several types of drones are employed in healthcare to optimize the delivery of medical supplies across varied terrains and distances. These include multirotor drones, single rotor helicopters, and fixed-wing hybrid VTOLs, each selected based on operational range, payload capacity, and geographic suitability.

Multirotor drones: These are used for short distances (10–12 km) and quick, low-preparation operations.

Single rotor helicopters: These are used to serve moderate distances (25–32 km) and are suited for hilly regions.

Fixed-wing hybrid VTOL drones: These cover long distances (60–120 km) with higher payload and terrain adaptability.

In Which Areas of Healthcare Have Drones Been Used So Far in India?

Drones are being utilized in various healthcare services across India to improve delivery speed, accessibility, and operational efficiency, particularly in remote and underserved areas. Drones have been used to serve the following healthcare areas so far:

Ophthalmology: Transport of corneal tissues and amniotic grafts for eye transplant procedures.

Blood components: Delivery of whole blood, packed RBCs, plasma, and platelets across hospital sites.

Infectious Disease: Sputum samples from individuals suspected of having TB flown from rural areas to testing units.

Public Health Logistics: Delivery of vaccines, surgical supplies, medicines, and diagnostic materials across states like Northeast, Karnataka, Himachal Pradesh, and NCR.

What Is the Future of Drone Technology in Public Health Trials

Drones present significant opportunities in public health by enabling the rapid transport of blood, diagnostic specimens, and biologics, including vaccines, to remote and underserved regions, effectively reducing delivery times and improving health outcomes. They have also demonstrated value in disaster response, emergency care, and critical supply delivery. While operational risks such as drone crashes, privacy concerns, and regulatory challenges exist, these can be mitigated through ongoing technological innovation, policy development, and rigorous safety assessments. Establishing drone delivery hubs near healthcare facilities and leveraging existing infrastructure like hospital rooftops, can support scalable integration. Moreover, public awareness and health education efforts are crucial to address apprehensions and build community trust. Further research is essential to evaluate long-term safety, optimize performance, and ensure that drone-based solutions align with ethical, legal, and social standards as they transition from pilot projects to national health strategies.

Conclusion

The integration of drone technology into India’s healthcare and clinical trial landscape marks a transformative step toward overcoming logistical challenges, especially in remote and underserved regions. Through initiatives like ICMR’s i-DRONE, drones have proven effective in reducing delivery times, preserving sample integrity, and expanding access to critical medical services. From transporting vaccines and blood components to supporting organ transplants and emergency care, drones are reshaping last-mile healthcare delivery. As regulatory frameworks evolve and infrastructure strengthens, drone-based solutions hold immense potential to enhance public health trials and research capabilities across the country. Continued investment, public awareness, and safety validation will be key to scaling this innovation sustainably and equitably.

Summary

The Indian Council of Medical Research (ICMR) is leveraging drones to improve clinical trial logistics and healthcare delivery, especially in remote areas.

Drones have successfully transported sensitive medical materials like human corneas, vaccines, blood products, and TB samples across difficult terrains.

The i-DRONE initiative, launched during the COVID-19 pandemic, has expanded to support broader public health and research needs across multiple Indian states.

The types of drones used include multirotor drones (short distances), single rotor helicopters (moderate distances), and fixed-wing hybrid VTOLs (long-range, high-payload).

Drones ensure sample integrity and temperature control, reduce delays, and provide cost-effective alternatives to traditional transport.

Key healthcare applications include ophthalmology, transfusion medicine, infectious disease diagnosis, and vaccine logistics.

The future of drone use in public health trials depends on scalable infrastructure, public awareness, safety assessments, and supportive policy frameworks.

CAR-T Cell Therapy: A Breakthrough in Cancer Immunotherapy

Tue, 05 Aug 2025 12:21:08 GMT

What Is CAR-T Cell Therapy?

CAR T-cell therapy is an advanced form of immunotherapy used to treat certain blood cancers. It involves modifying a patient’s T lymphocytes (T cells) to enhance their ability to identify and destroy cancer cells with this blood cancer therapy. By inserting a specially designed gene into these cells, they are reprogrammed to better recognize and attack malignant cells. In some cases, this therapy may eliminate cancer, while in others, it can extend survival and improve quality of life.

Types of Approved CAR T-cell Therapies

The FDA has approved several CAR T-cell therapies to treat certain leukemias, lymphomas, and multiple myeloma, typically after other treatments have failed. Therapies that have gained FDA approval under the CAR T-cell category include:

Idecabtagene vicleucel (Abecma) – Approved for relapsed or refractory multiple myeloma.
Axicabtagene ciloleucel (Yescarta) – Used in certain types of lymphoma.
Lisocabtagene maraleucel (Breyanzi) – Used as a treatment option for certain types of lymphomas.
Tisagenlecleucel (Kymriah) – Approved for certain pediatric and adult B-cell acute lymphoblastic leukemia (ALL) and some other lymphomas.
Ciltacabtagene autoleucel (Carvykti)- Approved for multiple myeloma treatment.
Brexucabtagene autoleucel (Tecartus)- Indicated for mantle cell lymphoma and B-cell ALL.
Obecabtagene autoleucel (Aucatzyl)- Gained regulatory approval for treating adult B-cell ALL.
Varnimcabtagene autoleucel (Qartemi) – This newly approved CAR T-cell therapy is used for relapsed/refractory B-cell non-Hodgkin lymphoma cases.
Actalycabtagene autoleucel (NexCAR19)- Approved in India for advanced lymphoma and leukemia, developed indigenously with international collaboration.

Fig. 1: FDA-approved CAR T-cell Therapies

When Is CAR T-Cell Therapy Recommended?

CAR T-cell therapy is recommended when certain blood cancers relapse or become resistant to conventional treatments, for example:

B-cell ALL
Primary mediastinal large B-cell lymphoma
Diffuse large B-cell lymphoma (DLBCL)
Mantle cell lymphoma
Follicular lymphoma
Multiple myeloma
High-grade B-cell lymphoma

What to Expect Before, During, and After CAR T-Cell Therapy

CAR T-cell therapy begins with leukapheresis, a procedure that collects your white blood cells using a special machine. These cells are then sent to a laboratory for genetic modification, which takes about three to six weeks. During this period, the individual may receive bridging therapy, such as chemotherapy or radiation to keep the cancer under control.

Before receiving the modified cells, you will undergo lymphodepleting chemotherapy (using chemotherapy to deplete lymphocytes) to help your body accept the modified cells. The CAR T-cell infusion is a short, IV-based procedure, often completed in under 30 minutes, and may require a brief hospital stay.

After treatment, a hospital stay of 7–10 days may be needed to ensure you are recovering well. For the next month, it is important to stay close to your treatment center for regular checkups. You will need a 24-hour caretaker and will be asked to avoid certain activities for up to two months.

The Benefits of CAR T-Cell Therapy

CAR T-cell therapy offers several powerful advantages, particularly for patients with relapsed or treatment-resistant blood cancers. Its unique approach offers the following key benefits:

Single-dose treatment
Short hospital stays
Faster recovery
Long-term remission potential
Bridge to stem cell transplant
Continued cancer surveillance
Effective in aggressive cancers

Fig. 2: Advantages of CAR T-cell Therapy

Future-Driven Systems Supporting CAR T-Cell Therapies

As part of India’s future-driven approach, Qartemi, a CD19-targeted CAR T-cell therapy developed by Immuneel Therapeutics, represents a significant advancement in personalized cancer care.6 Approved for relapsed or refractory B-cell non-Hodgkin lymphoma following the Phase 2 IMAGINE trial, it demonstrated high response rates and is priced at around 50 lakh, far more accessible than global CAR T therapies.
Qartemi is now available at leading Indian hospitals, reflecting the nation’s commitment to accessible innovation. Additionally, NexCAR19, India’s first indigenously developed CAR T-cell therapy by ImmunoACT, has received CDSCO approval and offers a safer, more affordable option for relapsed B-cell lymphomas. Priced at approximately ₹43.2 lakh, it further expands access to advanced therapies in the Indian healthcare system. Supporting these development, India’s I-DRONE initiative facilitates rapid delivery of medical supplies to remote areas, further strengthening the CAR T-cell therapy ecosystem.

Conclusion

CAR T-cell therapy signifies a significant breakthrough in oncology, particularly for those with blood cancers unresponsive to standard treatments. With several FDA-approved therapies available and innovative homegrown options like Qartemi gaining ground, access to this cutting-edge treatment is expanding. India’s commitment to making CAR T-cell therapy more accessible, backed by initiatives like I-DRONE and the development of affordable, globally benchmarked therapies, highlights a promising future for personalized medicine. Ongoing improvements in medical technology, support systems, and regulatory frameworks are enabling CAR T-cell therapy to redefine outcomes in blood cancers and potentially broader indications. With both Qartemi and NexCAR19, India now stands as a global leader in affordable CAR T-cell innovation. These advances are not just scientific milestones, but a shift toward equity and access in cancer care, potentially shaping models for other low- and middle-income countries.

Summary

CAR T-cell therapy is a cancer treatment that reprograms a patient’s T cells to target and destroy cancer cells.
It is primarily used in treating relapsed or refractory hematologic cancers such as B-cell non-Hodgkin’s lymphoma, ALL, and multiple myeloma.
Multiple FDA-approved CART therapies are approved globally, including Yescarta, Kymriah, Tecartus, and Abecma.
India has introduced indigenously developed CAR T therapies, such as NexCAR19 and Qartemi (varnimcabtagene autoleucel).
Qartemi is India’s second approved CAR T-cell therapy, benchmarked to international standards.
Future-driven strategies, including affordability, indigenous innovation, and supportive infrastructure, are expanding CAR T-cell access in India.

Which is the best CRO company in India?

Mon, 07 Jul 2025 12:33:32 GMT

Which is the best CRO company in India?

India is home to several well-established Contract Research Organizations (CROs), each with its own strengths and specializations. It’s difficult to declare a single “best” CRO as this can vary based on the type of services required.

Among these, CliniExperts is often recognised as one of the most prominent and reputable CROs based out of India. CliniExperts provides comprehensive research services across multiple therapeutic areas, including chemistry, biology, toxicology, and clinical research. It supports pharmaceutical, biotechnology, medical devices, and IVD industries on a global scale.

CliniExperts supports life sciences companies across the entire product lifecycle, from concept to commercialization, including clinical trial solutions. Their regulatory services span medical devices, biologics, cosmetics, and functional foods. They help clients with end-to-end documentation, regulatory filings, site inspections, and post-marketing support. The team’s proactive communication with CDSCO and other authorities improves the chances of approval while minimizing compliance risks and delays.

What makes CliniExperts stand out is its integrated service model, well-trained professionals, adherence to global quality standards, and long-standing collaborations with leading international pharmaceutical companies. Their facilities are GLP- and GCP-compliant and accredited by global regulatory authorities such as the US FDA, EMA, and WHO.

However, the “best” CRO depends on client-specific needs, such as therapeutic expertise, geographical coverage, regulatory compliance, and technological capabilities. Startups may prefer smaller, agile CROs with personalized services, while multinational pharmaceutical firms might opt for larger organizations with global reach.

What is CRO in full form?

Mon, 07 Jul 2025 12:32:20 GMT

What is CRO in full form?

The full form of CRO is Contract Research Organization. A CRO is a service-based company that supports pharmaceutical, biotechnology, and medical device companies in the research and development (R&D) of drugs and medical products.

CROs provide outsourced services across the entire drug development lifecycle, including:

Preclinical studies (in vitro and animal testing)
Clinical trials (Phases I to IV)
Regulatory submissions and compliance
Pharmacovigilance and safety monitoring
Data management and biostatistics
Authorized Agent and Import Assistance Services
Global Regulatory Services in EU, UK and USA

The primary advantage of CROs is their ability to reduce time and cost for sponsors by offering specialised expertise, regulatory knowledge, and operational efficiency. They allow sponsors to focus on core innovation while leveraging the CRO’s infrastructure, experience, and scalability.

CROs can be global multinational corporations or region-specific organizations offering niche services. In India, the CRO sector has seen significant growth due to cost-effective operations, skilled professionals, and a large patient population for clinical trials.

At CliniExperts, clients benefit from a one-stop regulatory partner trusted by top healthcare and life sciences brands. Specialising in medical device and pharma regulatory affairs, the regulatory solutions firm offers a 360-degree solution, from dossier preparation and audits to post-market surveillance and legal representation. Their team of domain experts ensures accurate submissions, faster approvals, and hassle-free licensing.

CliniExperts also supports life sciences companies across the entire product lifecycle, from concept to commercialisation. Its regulatory services span medical devices, biologics, cosmetics, and functional foods. They help clients with end-to-end documentation, regulatory filings, site inspections, and post-marketing support. The team’s proactive communication with CDSCO and other authorities improves the chances of approval while minimizing compliance risks and delays. Whether entering the Indian market or expanding globally, CliniExperts ensures your compliance journey is smooth and risk-free.

How to start a CRO in India?

Mon, 07 Jul 2025 12:31:44 GMT

How to start a CRO in India?

Starting a Contract Research Organization (CRO) in India involves meticulous planning, strong scientific expertise, regulatory understanding, and business acumen. Here’s a step-by-step overview of how to establish a CRO:

Business Plan & Feasibility Study: Define your niche—preclinical, clinical trials, regulatory affairs, data management, etc. Assess market demand, competition, and financial projections.
Legal Registration: Register your business as a Private Limited Company or LLP. Obtain PAN, GST, and other statutory licenses.
Regulatory Approvals: Apply for approval from the Drugs Controller General of India (DCGI) and ensure compliance with Indian GCP (Good Clinical Practice) guidelines. Accreditation with regulatory bodies like NABL or GLP certification may be required for certain services.
Infrastructure & Equipment: Set up office space and labs (if required). Ensure you have controlled environments, IT systems for data capture, and secure storage for documentation.
Staffing: Hire qualified personnel—clinical research associates, regulatory specialists, project managers, biostatisticians, data managers, and quality assurance professionals. Training in ICH-GCP is essential.
Quality Systems: Develop SOPs (Standard Operating Procedures), quality manuals, and documentation practices. Implement a quality management system aligned with GCP standards.
Technology & Data Security: Adopt clinical trial management software (CTMS), electronic data capture (EDC) systems, and ensure data confidentiality and compliance with 21 CFR Part 11 and GDPR if working with global sponsors.
Networking & Partnerships: Collaborate with hospitals, investigators, and ethics committees. Building credibility through a few successful trials can help establish your CRO’s reputation.
Insurance & Risk Management: Clinical trials require insurance coverage for participants and professional liability protection for the organization.
Marketing & Business Development: Participate in pharma expos, collaborate with sponsors, and build an online presence. Demonstrating regulatory compliance, success stories, and scientific excellence will attract clients.

Establishing a CRO is capital and compliance-intensive, but with the right expertise and planning, India’s growing pharma and biotech industry offers immense potential.

Is CRO in demand?

Mon, 07 Jul 2025 12:31:03 GMT

Is CRO in demand?

Yes, Contract Research Organizations (CROs) are in high demand, both globally and within India. The increasing complexity of drug development, regulatory challenges, and rising R&D costs have made outsourcing to CROs a strategic necessity for pharmaceutical, biotechnology, and medical device companies.

Several key factors contribute to the growing demand for CRO services:

1. Rising R&D Costs and Time Constraints: Drug development is a long, costly, and resource-intensive process. Partnering with CROs allows companies to reduce operational costs while accelerating timelines.
2. Globalization of Clinical Trials: Sponsors now conduct multicenter trials across different geographies to access diverse patient populations. CROs provide the local expertise, regulatory know-how, and logistical support required for these trials.
3. Regulatory Complexity: Regulatory requirements have become increasingly stringent and country-specific. CROs help navigate these complex environments by ensuring compliance with international and local guidelines such as ICH-GCP, US FDA, EMA, and CDSCO norms in India.
4. Specialized Expertise: CROs bring scientific, operational, and therapeutic area expertise that companies may not have in-house, particularly in early-phase research, rare diseases, or pharmacovigilance.
5. Digital Transformation: The use of technology platforms like eClinical systems, AI in trial monitoring, and real-world evidence tools has improved efficiency. CROs are investing heavily in digital tools, making them even more attractive to sponsors.
6. India as a Preferred Destination: India offers a large patient population, skilled clinical research professionals, cost advantages, and well-established research infrastructure. As a result, the demand for Indian CROs is growing rapidly, particularly for Phase II-IV trials and post-marketing surveillance.

The Indian CRO market is expected to grow significantly in the coming years, driven by the rise in chronic diseases, new drug development, and global pharma outsourcing. Reports estimate the Indian CRO market size to reach over USD 2 billion by 2030, making it a thriving sector for investment and careers.

CROs are not only in demand today but are expected to play an increasingly central role in the future of healthcare innovation. As regulatory requirements grow stricter, CliniExperts offers a streamlined path to compliance. They specialise in registration, import/export licensing, regulatory filing, and ongoing compliance support for a wide range of product categories. Their proactive approach ensures businesses avoid roadblocks and remain aligned with dynamic regulatory changes both in India and globally.

What does a CRO do?

Mon, 07 Jul 2025 12:30:19 GMT

What does a CRO do?

A Contract Research Organization (CRO) is a regulatory affairs service provider that supports pharmaceutical, biotechnology, and medical device companies in conducting research and development (R&D), particularly in clinical trials and regulatory processes. CROs act as external partners that help sponsors bring new drugs and medical products to market more efficiently.

Here are the core functions of a CRO:

Clinical Trial Management: CROs design and manage clinical trials from Phase I to Phase IV. This includes study protocol development, site selection, patient recruitment, monitoring, data collection, and reporting.
Regulatory Affairs: CROs assist in obtaining approvals from regulatory bodies like the Drugs Controller General of India (DCGI), US FDA, or EMA. They prepare submission dossiers, ensure compliance with guidelines, and manage interactions with regulatory agencies.
Data Management & Biostatistics: They handle clinical data collection using electronic data capture (EDC) systems, perform statistical analysis, and ensure data integrity for regulatory submissions.
Preclinical Research: Many CROs provide non-clinical research services such as toxicology studies, pharmacokinetics, and in vitro testing to assess drug safety before clinical trials.
Medical Writing: CROs prepare scientific documents including study protocols, investigator brochures, clinical study reports (CSRs), and manuscripts for publication.
Pharmacovigilance: They monitor and report adverse drug reactions during and after clinical trials, ensuring ongoing safety of investigational products.
Project and Site Management: CROs coordinate with hospitals, research sites, ethics committees, and investigators to manage operational aspects of the study.
Training and Quality Assurance: CROs often provide training for clinical staff and implement quality assurance practices to meet GCP and ISO standards.

By outsourcing these services to a CRO, sponsors can save time, reduce costs, and access specialized expertise. This model enables faster drug development while ensuring scientific and regulatory rigour.

India’s CRO landscape includes both homegrown organisations and subsidiaries of international firms. Companies like CliniExperts are renowned pioneers in providing clinical trial and research services.

CliniExperts is a trusted name in regulatory solutions, offering full-spectrum services in medical devices, drugs, IVDs, cosmetics, and nutraceuticals. They have a proven track record of helping companies obtain import, manufacturing, and test licenses. With a strong presence in India and partnerships in the US, UK, and EU, CliniExperts ensures compliance across borders and supports rapid product development and launch timelines.

CliniExperts brings an integrated approach to regulatory compliance for healthcare and life sciences businesses in India and abroad. From classification and licensing to post-market vigilance, the team is equipped with the scientific and legal expertise required to meet diverse compliance mandates. With a client-first philosophy, CliniExperts designs customized regulatory roadmaps for smooth market entry, product launches, and long-term sustainability.

What is a CRO in pharma?

Mon, 07 Jul 2025 12:28:50 GMT

What is a CRO in pharma?

In the pharmaceutical industry, a CRO stands for Contract Research Organization. It is a company that provides outsourced research services to pharmaceutical, biotechnology, and medical device companies. CROs help these companies manage the complex and resource-intensive process of developing new drugs and medical products by handling various aspects of research and regulatory requirements. From planning product testing to ensuring all the regulatory checks are in place, CROs provide assistance every step of the way.

CROs are a critical part of the drug development ecosystem, offering a wide range of services, such as:

Preclinical research: Testing new compounds in laboratories and on animals to assess safety before human trials.
Clinical trial management: Conducting and monitoring human clinical trials (Phases I–IV), including patient recruitment, data collection, and adherence to regulatory protocols.
Regulatory submissions: Preparing and managing documentation required for approvals from national and international regulatory agencies like the CDSCO (India), US FDA, or EMA.
Pharmacovigilance: Monitoring and reporting adverse effects of drugs once they are in the market or during trials.
Data management & biostatistics: Collecting, analyzing, and interpreting clinical data for decision-making and regulatory filings.

Pharma companies work with CROs to save time, reduce costs, and gain access to specialized expertise. For instance, running a global clinical trial requires infrastructure, trained personnel, and regulatory understanding in multiple countries. CROs, with their experience and networks, manage these operations efficiently.

There are two types of CROs:

Full-service CROs – offer end-to-end services from preclinical to post-marketing surveillance.
Niche CROs – specialize in specific functions like clinical monitoring, regulatory affairs, or data analytics.

India is a major hub for CRO services due to its cost-effectiveness, skilled workforce, and a large, diverse patient population. Among leading Indian CROs, CliniExperts is emerging as a pioneer in regulatory consulting field.

With a strong focus on regulatory excellence, CliniExperts bridges the gap between innovation and compliance. Their in-depth knowledge of Indian regulatory frameworks and international standards allows them to manage critical submissions and expedite approvals. Their offerings range from DCGI permissions to test license applications, clinical trial oversight, and custom regulatory strategies for complex products. They serve not just as consultants but as strategic partners, aligning regulatory pathways with business goals.

A CRO acts as a strategic partner to pharmaceutical companies, ensuring that new drugs are researched, tested, and brought to market faster and more efficiently, while maintaining compliance with global standards. Their role is becoming increasingly significant as pharma companies seek to innovate while controlling development costs.

Who invented CRO?

Mon, 07 Jul 2025 12:21:32 GMT

Who invented CRO?

The concept of a Contract Research Organization (CRO) was not invented by a single individual but rather evolved over time in response to the increasing complexity of drug development and the need for specialised services. Nonetheless, the modern CRO industry began to take shape in the late 1940s and early 1950s, early in the United States and Europe.

One of the first recognized CROs was Charles River Laboratories, founded in 1947 by Henry Foster in Massachusetts, USA. Originally focused on breeding and supplying laboratory animals for research, the company expanded its services to include preclinical and clinical research. Charles River Laboratories laid the groundwork for what would become the full-service CRO model we know today.

Another key pioneer in the CRO industry was Dennis Gillings, a biostatistician and professor at the University of North Carolina, who founded Quintiles in 1982. Quintiles became one of the largest CROs in the world and played a major role in establishing CROs as essential partners in the pharmaceutical R&D process. In 2016, Quintiles merged with IMS Health to form IQVIA, now considered the largest and most influential CRO globally.

The rise of CROs was driven by multiple factors:

Increasing regulatory requirements (like FDA and EMA guidelines)
High costs and risks associated with in-house drug development
Global expansion of clinical trials
The need for quicker, more efficient ways to bring new therapies to market

By outsourcing specific research functions to CROs, pharmaceutical companies could focus on innovation while relying on the expertise and infrastructure of CROs for clinical operations, regulatory compliance, and data management.

In India, the CRO industry began gaining momentum in the early 2000s, aligned with the globalisation of clinical trials and the growth of India’s pharmaceutical sector. Companies like CliniExperts became pioneers in the Indian CRO landscape.

CliniExperts is an apex regulatory consulting firm that provides regulatory assistance for manufacturers, importers, and sponsors dealing in medical devices, in vitro devices, cosmetics, biologics, pharmaceuticals, food, food supplements, and clinical research. Besides domestic operations, the firm also provides assistance to companies considering expansion in the US, UK, and European markets. With 15+ years of expertise in the field, the organisation has had several happy clients and relations with stakeholders, making CliniExperts a growth-oriented place to work.

CliniExperts excels in offering comprehensive, strategic regulatory advice for India’s regulated sectors. Its experts identify the most suitable regulatory route and support documentation, submissions, and liaison with authorities. Moreover, its global alignment with US and EU regulations makes them the go-to firm for companies seeking cross-border product launches.

While there is no single inventor of CROs, individuals like Henry Foster and Dennis Gillings were instrumental in shaping the industry. The CRO model emerged from the evolving needs of the pharma industry and has since become a vital part of the global healthcare innovation process.

What is the name of CRO?

Mon, 07 Jul 2025 12:20:37 GMT

What is the name of CRO?

The term CRO stands for Contract Research Organization, and this is the standard industry name used globally. While “CRO” is the most widely accepted acronym, depending on the specific services offered and the region, CROs may also be referred to in slightly different terms or categorised into specialized subtypes.

Here are a few related names and designations often associated with CROs:

Clinical Research Organization – Sometimes used interchangeably with Contract Research Organization, especially when the CRO focuses mainly on clinical trial services. While not a formal alternative, this term emphasises the clinical aspect of their work.
Full-Service CRO – A CRO that provides a complete range of services from preclinical studies to Phase I-IV clinical trials, regulatory submissions, and post-marketing surveillance. These organizations are equipped to handle every aspect of drug development.
Specialty or Niche CRO – These are CROs that specialize in one or two areas, such as data management, biostatistics, regulatory consulting, or pharmacovigilance. They may also focus on specific therapeutic areas like oncology, cardiology, or rare diseases.
Preclinical CRO – Focuses exclusively on non-clinical research services such as toxicology, pharmacokinetics, and in vitro/in vivo testing.
SMO (Site Management Organization) – While not a CRO, SMOs are closely related. They manage clinical trial sites and assist CROs with on-the-ground operations like patient recruitment and monitoring.
CDMO (Contract Development and Manufacturing Organization) – Although distinct from CROs, CDMOs sometimes offer overlapping services, particularly in drug formulation and analytical development. Some companies operate as both CROs and CDMOs.
Outsourcing Partner/Vendor – In business and procurement documents, CROs may be generically referred to as “vendors” or “outsourcing partners.”

Regardless of the name used, the fundamental role of a CRO is to support pharmaceutical and biotechnology companies in conducting research more efficiently and compliantly, particularly during drug development and clinical trials.

In India and globally, “CRO” remains the official and widely recognized term. It is used by regulatory agencies, sponsors, and industry professionals alike to describe organizations that contractually manage clinical or scientific research activities. Among to tier CROs in India, CliniExperts is emerging as a pioneer in regulatory affairs services with 15+ years of service.

Navigating Indian regulatory frameworks can be overwhelming, but CliniExperts makes it simple. CliniExperts’ pharmaceutical consultants help prepare and submit documentation to regulatory bodies, design and manage clinical trials, provide strategic insights into trial design, patient recruitment, and data analysis, draft dossiers, and ensure that clinical trials meet required regulatory standards. Their long-term expertise helps companies accelerate licensing and drug approval processes, minimise costs and delays, and maintain compliance throughout the product lifecycle.

The firm’s in-depth understanding of CDSCO requirements, combined with real-time tracking and legal insights, enables clients to stay ahead in compliance. From medical device classification to food product import licensing, CliniExperts provides tailored, efficient, and accurate regulatory solutions!

How big is the CRO industry?

Mon, 07 Jul 2025 12:18:45 GMT

How big is the CRO industry?

The Contract Research Organization (CRO) industry has grown significantly over the past few decades, becoming a vital part of the global pharmaceutical and biotechnology ecosystem. As of 2024, the global CRO market is estimated to be worth over USD 80 billion, with projections suggesting it could be around USD 129.8 billion by 2029, driven by increasing R&D demands and the need for cost-effective outsourcing solutions.

This industry’s growth is primarily attributed to the rising complexity and cost of drug development. Pharmaceutical companies are increasingly outsourcing various functions—such as clinical trials, regulatory submissions, and laboratory testing—to CROs to streamline operations, reduce time-to-market, and manage risk. By doing so, they gain access to specialized expertise without having to invest in internal infrastructure.

North America holds the largest share of the CRO market, largely due to the presence of major pharmaceutical players and advanced healthcare infrastructure. However, Asia-Pacific, especially countries like India and China, is experiencing rapid growth. This is fueled by lower operational costs, skilled scientific workforce, large patient populations for clinical trials, and supportive government policies.

CRO services span a wide range, including clinical trial management, biostatistics, regulatory affairs, data management, pharmacovigilance, medical writing, and post-marketing surveillance. Full-service CROs offer end-to-end support from preclinical to Phase IV clinical trials, while niche CROs specialize in particular therapeutic areas or service segments.

The CRO industry is also witnessing consolidation through mergers and acquisitions. Large CROs such as IQVIA, Labcorp Drug Development, ICON plc, and Parexel dominate the market, offering global capabilities and integrated solutions. At the same time, mid-sized and regional CROs continue to thrive by offering flexible, tailored services.

Technological innovations, such as decentralized clinical trials (DCTs), artificial intelligence (AI), and real-world data analytics, are further transforming the CRO landscape. These tools help CROs improve efficiency, enhance data quality, and support more patient-centric research models.

The CRO industry is not only large but also dynamic and essential to modern drug development. Its scale, global reach, and continual evolution make it a foundation in accelerating medical innovation and delivering new therapies to patients worldwide.

What are company CROs?

Mon, 07 Jul 2025 12:17:32 GMT

What are company CROs?

The term “company CROs” refers to Contract Research Organizations that operate as formal businesses providing research and development services on a contractual basis to companies involved in the pharmaceutical, biotechnology, and medical device sectors. The CROs are independent entities or subsidiaries that support sponsors in conducting various aspects of the clinical trial and regulatory process.

CRO companies offer a wide range of services, such as:

Clinical trial design and management
Regulatory consulting and submissions
Site and patient recruitment
Data management and statistical analysis
Medical writing and pharmacovigilance
Preclinical research and laboratory services

Essentially, company CROs act as an extension of the sponsor’s R&D department, enabling companies to bring drugs or devices to market faster and more efficiently. These services are particularly valuable for small and mid-sized pharmaceutical firms that may lack the internal infrastructure to conduct large-scale clinical studies.

Some CROs are full-service organizations, meaning they handle the entire clinical development process—from protocol development to final regulatory submission. Others are niche CROs, specializing in certain therapeutic areas (e.g., oncology, neurology) or specific services (e.g., Phase I trials, regulatory strategy, bioanalytical testing).

Company CROs vary in size and global presence. In India, notable CRO companies include Syngene International, Veeda Clinical Research, CliniExperts, and Lambda Therapeutic Research, among others. These organizations have contributed significantly to India’s position as a growing hub for clinical research and regulatory services.

Navigating Indian regulatory frameworks can be overwhelming, but CliniExperts makes it simple. With its client-centric model, CliniExperts customises regulatory strategies based on product classification, market entry goals, and legal requirements. Their experts provide real-time support through dossier development, clinical trial design, safety assessments, and compliance training. They also assist with registrations, renewals, and audits, reducing regulatory risk and expediting time-to-market.

Working with company CROs allows sponsors to reduce costs, mitigate risks, access global patient populations, and leverage expert knowledge. Moreover, with increasing regulatory complexity and the push for faster approvals, the strategic role of CROs has expanded beyond execution to include innovation, compliance, and patient engagement.

Company CROs are specialised business entities that provide outsourced research services to help bring new drugs, devices, and treatments to market efficiently and compliantly.

What Is CRO in India?

Wed, 02 Jul 2025 12:22:51 GMT

What Is CRO in India?

In India, a CRO or Contract Research Organization is a company that provides support to the pharmaceutical, biotechnology, and medical device industries with research services outsourced on a contract basis. These services can range from preclinical research, clinical trial management, regulatory affairs, biostatistics, data management, to post-marketing surveillance. Right from planning and execution to regulatory compliance and data management, these organisations ensure easy workflow of clinical trials and research, so that companies can focus more on their innovation and less on management of research needs.

CROs in India have seen significant growth over the past two decades, fueled by the country’s large and diverse patient pool, cost-effective operations, and a growing number of skilled professionals in the life sciences sector. Many global pharmaceutical companies look to India not just for the cost advantage but also for the speed and scale that Indian CROs can offer in conducting clinical trials.

A key function of CROs is to ensure that clinical trials are conducted in compliance with regulatory standards while maintaining ethical practices. They often act as the bridge between sponsors (drug or device developers) and regulatory bodies like the Central Drugs Standard Control Organisation (CDSCO). From preparing clinical trial protocols, identifying trial sites, recruiting patients, managing data, and preparing dossiers for submission, CROs handle the operational complexity that comes with drug development.

However, the industry is not without its challenges. Regulatory scrutiny has increased in recent years to ensure patient safety and data integrity. Ethical concerns and the need for greater transparency in trial conduct have led to tightened guidelines, which credible CROs have adapted to with improved compliance systems.

CliniExperts is India’s leading regulatory solutions provider offering end-to-end compliance services for pharmaceuticals, cosmetics, medical devices, in-vitro diagnostics (IVDs), and food. With over 15 years of expertise, CliniExperts supports manufacturers and importers by navigating complex Indian and global regulatory pathways. Their comprehensive offerings include CDSCO registration, licensing, post-approval support, and regulatory intelligence. CliniExperts also facilitates global market entry by ensuring product compliance with US FDA, EMA, MHRA, and other international bodies.

The apex regulatory consulting body serves as an essential partner in the research and clinical trials development pipeline by providing specialized services that help bring new therapies to market faster, more efficiently, and in full alignment with global standards. So, if you are in need of a reliable CRO, contact CliniExperts for a wide range of regulatory solutions for both international and domestic market.

Regulatory Compliance in Dermatology and Clinical Trials

Mon, 02 Jun 2025 16:44:53 GMT

Introduction : Regulatory Compliance in Dermatology and Clinical Trials

Clinical trials are essential to create the novel medical cures and treatments. They produce vital information that aids pharmaceutical firms in introducing novel medications to the market. Clinical trials are scientific investigations designed to evaluate the safety and efficacy of novel therapies or interventions. These trials in dermatology are mainly concerned with assessing the effectiveness of biologic medicines, systemic medications, and topical treatments for different skin problems. Creating evidence-based therapy recommendations to enhance patient outcomes is one of the main objectives of clinical trials in dermatology. Patients with mild to severe skin problems are among the varied participants in these trials.

The Significance of Clinical Trials in Dermatology

Clinical trials serve as the basis for creating new treatments and refining those that already exist. Every development in dermatology, from topical therapies to systemic biologics, is the result of thorough clinical study. Furthermore, complicated immunological dysregulation and genetic predispositions are frequently the root causes of skin disorders like vitiligo and psoriasis. Researchers can examine these pathways in a variety of patient populations through clinical trials, which improves therapy methods and allows for more precise diagnosis.

Dermatology clinical trials also give many patients the chance to participate in a clinical trial, which gives them access to cutting-edge therapy that may not be possible with conventional treatment alternatives. For patients who have run out of options for traditional therapy, trials that concentrate on severe or treatment-resistant illnesses provide hope.

The Role of Regulatory Compliance in Dermatology and Clinical Trials

Fig. 1: Goals of Regulatory Compliance in Dermatological Clinical Trails

Keeping Patients Safe: Protecting the rights and welfare of the patients taking part in clinical trials is one of the main goals of regulatory compliance. Researchers must adhere to stringent guidelines set forth by regulatory bodies for patient recruitment, informed consent, and adverse event monitoring. This guarantees that patients’ rights and privacy are upheld during the trial and that they are not exposed to needless dangers.

Preserving the Integrity of Data: Since it serves as the foundation for assessing the safety and effectiveness of novel treatments and therapies, data integrity is essential in clinical trials. To guarantee the precision, dependability, and consistency of the data produced throughout the trial, regulatory compliance requires the application of standardized data collection techniques and strict quality control procedures. This is crucial so that researchers and regulators may use the trial results to make well-informed judgments.

Promoting Accurate Outcomes: By guaranteeing that trials are carried out in a way that is scientifically rigorous, regulatory compliance plays a crucial role in enabling accurate outcomes. Following the right rules and regulations reduces bias, improves the validity of the findings, and makes the findings more reproducible. In the end, this enhances the trial’s and the scientific community’s general credibility.

Accountability and Transparency: Transparency and accountability in clinical trials are further enhanced by regulatory compliance. Researchers must record and disclose every facet of the trial, including study design, methods, and statistical analysis, in order to comply with regulatory regulations. Greater scrutiny and peer review are made possible by this thorough reporting, which enhances the validity and dependability of the trial’s conclusions.

Cooperation and Harmony: International cooperation and standardization in clinical research are promoted by regulatory compliance. Although many nations have their own regulatory systems, international standards are becoming more and more important in an effort to expedite the drug development process and guarantee uniform quality across borders. By following these guidelines, researchers can make it easier for data and findings to be shared, which will promote a more effective and cooperative method of expanding medical knowledge.

The Process of Clinical Trials in Dermatology

Strategies for Ensuring Compliance in Clinical Trials

Fig. 2: Process Flow of Regulatory Compliance in Dermatological Clinical Trials

Creating a Plan for Compliance: Ensuring regulatory compliance in clinical trials requires the creation of a thorough compliance plan. Obtaining the required permits and permissions, establishing roles and duties, documenting procedures, and conducting routine audits to find and fix any possible non-compliance concerns are just a few of the activities and procedures that should be outlined in this plan.
Education and Training for Clinical Trial Employees: Maintaining regulatory compliance in clinical trials requires a workforce that is knowledgeable and well-trained. Putting money into the education and training of all trial staff members helps guarantee that they are fully aware of the rules, laws, and best practices that apply. Keeping up with the constantly changing regulatory environment also requires regular training and upgrades.
Regular Audits and Monitoring: To find and address any instances of non-compliance that can arise during a clinical study, regular audits and monitoring activities are essential. To give an unbiased evaluation of the trial’s adherence to rules and laws, these audits must be carried out by certified professionals or impartial outside parties. The integrity and credibility of the trial are enhanced by the prompt identification and resolution of non-compliance issues. Furthermore, it’s critical to remember that compliance in clinical trials involves more than just following the law. It also includes safeguarding the rights of participants and ethical issues.

Problems and Solutions in Clinical Trials for Dermatology Clinical trials are not without difficulties, even though they have greatly improved dermatological care. These difficulties range from the need to comply with strict regulations to the difficulty of recruiting patients. Nevertheless, creative ways to get past these challenges have surfaced.
Conclusion Regulatory compliance is more than a legal necessity, it is fundamental to ethical, scientific, and clinical excellence in dermatology trials. It protects participants, preserves data integrity, and promotes transparency, ultimately supporting the development of effective and safe dermatological treatments. As clinical research continues to evolve, embracing compliance not only fosters innovation but also builds the public trust essential for scientific advancement. This was it all about Regulatory Compliance in Dermatology and Clinical Trials.Hope you all enjoyed post of Regulatory Compliance in Dermatology and Clinical Trials

Section	Details
1. Structured Process of Clinical Trials in Dermatology	Protocol development Patient recruitment Obtaining informed consent Monitoring for treatment effectiveness and side effects Rigorous statistical data analysis
2. Multidisciplinary Collaboration	Involves cooperation among: Dermatologists Clinical researchers Pharmaceutical companies Regulatory authorities Patient advocacy groups
3. Variable Trial Duration	Depends on: Research objectives Nature and severity of the condition Duration: weeks/months to several years
4. Placebo-Controlled Trial Design	Some receive investigational treatment; others receive placebo Determines true treatment efficacy Ethical considerations: – Full disclosure of risks and benefits – Mandatory informed consent
5. Contribution to Advancing Dermatological Care	Evaluates safety and efficacy of treatments Enhances understanding of skin diseases Improves patient outcomes

Problems and Solutions in Clinical Trials for Dermatology

Clinical trials are not without difficulties, even though they have greatly improved dermatological care. These difficulties range from the need to comply with strict regulations to the difficulty of recruiting patients. Nevertheless, creative ways to get past these challenges have surfaced.

Typical Challenges in Trial Administration

Creative Approaches to Overcoming Obstacles

Patient recruitment is one of the biggest obstacles in clinical trials for dermatology.
There might not be as many participants with particular skin conditions, which makes it difficult to get the required sample size.Clinical trials are also subject to strict regulatory requirements that demand meticulous protocol adherence and copious documentation, both of which can be difficult and time-consuming.

A variety of tactics have been used by researchers and CROs to address the difficulties related to patient recruitment.
These tactics include using digital platforms for patient outreach, interacting with healthcare providers, and working with patient advocacy groups.

Conclusion

Regulatory compliance is more than a legal necessity, it is fundamental to ethical, scientific, and clinical excellence in dermatology trials. It protects participants, preserves data integrity, and promotes transparency, ultimately supporting the development of effective and safe dermatological treatments. As clinical research continues to evolve, embracing compliance not only fosters innovation but also builds the public trust essential for scientific advancement.

This was it all about Regulatory Compliance in Dermatology and Clinical Trials.

Hope you all enjoyed post of Regulatory Compliance in Dermatology and Clinical Trials

Streamlining Clinical Investigations: From Study Planning to Execution

Tue, 04 Feb 2025 15:20:32 GMT

Streamlining Clinical Investigations: From Study Planning to Execution

Clinical investigation is the backbone of medical progress, offering crucial information for assessing the efficacy and safety of new treatments. By 2028, the global clinical investigation market is projected to rise to USD 83.5 billion, underscoring the increasing importance of carefully thought-out trials.

However, delays occur in 86% of clinical studies, frequently due to inadequate planning. Researchers can minimize these setbacks and improve trial results by employing strategic methods.

Careful planning is required throughout the entire process of developing a clinical trial and pushing it through to completion. Choosing adequate trial designs and finding qualified participants while maintaining regulatory compliance are essential components of effective preparation.

In clinical investigation, strategic planning directs each stage from conception to implementation to achieve favorable outcomes and effective advancement.

What Is a Strategy for a Clinical Trial?

The general plan and methodology intended to carry out a clinical trial effectively is referred to as the clinical trial strategy. It involves defining the study’s goals, patient demographics, endpoints, treatment plans, and techniques for gathering data.

A clear clinical trial strategy serves as a road map for the entire experiment, directing choices and guaranteeing that the trial achieves its objectives. A well-thought-out clinical trial design can help researchers accomplish several significant goals.

Researchers develop a thorough clinical trial strategy by establishing goals, determining the target population, choosing trial designs, and organizing recruitment tactics.

This approach ensures a compliant and effective trial execution by taking into account resource allocation, ethical issues, and regulatory constraints. The likelihood of a clinical study being carried out successfully and producing accurate results is increased by careful planning.

The Importance of Planned Clinical Investigation

Clinical investigation plays a vital role in improving patient care and medical knowledge. A clinical trial’s strategic planning seeks to accelerate the procedure while guaranteeing that it is morally, scientifically, and regulatory correct. This entails establishing precise goals, picking suitable approaches, and efficiently allocating resources.

The significance of strategic planning in clinical investigation is emphasized by the following points:

It reduces dropout rates by assisting in the identification and recruitment of qualified participants.
It guarantees complete data collection techniques, producing precise and trustworthy outcomes.
Effective planning prevents wasteful spending by allocating resources sensibly.
By ensuring that all ethical standards and legal criteria are fulfilled, strategic planning helps to avoid legal problems.
Having backup plans and anticipating possible dangers enables quick and efficient reactions to unexpected problems.

Fig. 1: Advantages of Strategic Planning in Clinical Investigation

The Step-by-Step Process of Clinical Investigation

Development of Concepts

Specify the main goal and important questions that the trial seeks to address.
To comprehend the gaps and present knowledge, do a thorough review.

Design of Protocols

Establish selection criteria for participants to guarantee a uniform study population.
Establish primary and secondary endpoints to gauge the success of the experiment.
Describe in detail the steps involved in gathering data, implementing the intervention, and following up with participants.
Involve doctors or medical advisers having experience in therapeutic area.

Evaluation of Feasibility

Determine possible trial locations by taking into account variables such as the infrastructure, patient population, and investigator experience.
Examine the staffing, finance, and equipment availability of the required resources.

Create Administrative Records

Make sure all administrative procedures are finished, such as creating a clinical research study budget plan, establishing contracts if outsourcing to a contract research organization (CRO), and verifying a confidential disclosure agreement (CDA).
Create the investigator site file with the necessary documentation to assess the quality of the data and research conducted.

Planning and Compliance with Regulations

Create the study protocol and submit it for approval to ethics committees.
Send the necessary paperwork for trial authorization to the appropriate regulatory agencies (such as the CDSCO, FDA, or EMA).
6.Oversee Experimental Products

Assure safety and efficacy by obtaining, storing, and administering the investigational product in accordance with the study protocol.
Purchase the product from a reputable vendor, make sure it complies with Good Manufacturing Practices (GMP), and keep an eye on how site employees are handling it.

Detailed Operational Planning

Create an elaborate strategy that includes deadlines, objectives, and roles.
Determine possible threats and plans to reduce them.

A Well-Thought-Out Recruitment Strategy

Create a multifaceted recruitment strategy that includes direct mail, advertising, community outreach, and referrals. Include a budget for related expenses and participant remuneration.
Track the hiring process, resolve obstacles, keep in touch with the hiring team, and record the procedure for regulatory reporting.

Selecting a Site Early

Make sure all materials and equipment are available and train site personnel.
Start the participant recruitment process based on the inclusion/exclusion criteria.

Conducting a Trial

To guarantee data integrity and protocol compliance, make routine monitoring visits.
Assure trial participants of continuous communication and assistance.

Reporting and Data Analysis

To resolve discrepancies, clean the data, and then analyze it using the predetermined statistical strategy.
Create thorough reports and share the findings via presentations and publications.
12Submission to and Approval by the Regulatory Body

Send the trial’s findings to the appropriate authorities for approval.
To learn more about the treatment’s long-term consequences, schedule any post-approval research that may be required.

Fig. 2: Phases of Clinical Trial Investigation

Important Legal Requirements

For clinical investigation to maintain their ethical and scientific integrity, important regulatory requirements are essential.

A crucial regulatory criterion is informed consent, which guarantees that participants are completely informed about the goals, methods, risks, and advantages of the trial before consenting to take part.

Good Clinical Practice (GCP): GCP regulations guarantee that the clinical investigation is compiled to ethics. Trials that are meant to support regulatory filings must adhere to GCP.
Registration for the trial: It is frequently required by law to register clinical studies in databases that are open to the public, such as Clinical Trials Registry- India (CTRI) and ClinicalTrials.gov. This encourages openness and makes trial data accessible to the general population.
Ethics Committees and Institutional Review Boards (IRBs): To make sure clinical trial procedures are morally acceptable, IRBs and ECs examine and approve them. Before a trial can start, they must provide their consent.
Safety reporting: Regulatory agencies and IRBs/ECs must be notified as soon as sponsors experience any negative outcomes or side effects during the trial. This guarantees continuous participant safety monitoring.
Confidentiality and privacy of data: Participant data privacy and confidentiality are safeguarded by laws like the General Data Protection Regulation (GDPR) in the EU and the Health Insurance Portability and Accountability Act (HIPAA) in the US.

Conclusion

Streamlining clinical investigations is crucial for advancing medical science, improving patient care, and efficiently bringing treatments to market. Strategic planning ensures trials address key research questions, comply with ethical and regulatory standards, and utilize resources effectively.

By tackling challenges like recruitment delays and ensuring data integrity, researchers can enhance trial success. Adhering to regulations like GCP and informed consent safeguards participant welfare and scientific validity.

With structured strategies, clinical investigation can accelerate innovation, foster trust, and remain the cornerstone of medical progress, benefiting patients and global healthcare.

Navigating Clinical Trials: How Research Services of CliniExperts Can Accelerate Your Study

Wed, 18 Dec 2024 16:07:11 GMT

Navigating Clinical Trials: How Research Services of CliniExperts Can Accelerate Your Study

Overview

Navigating clinical trials involves understanding the phases of research that test new treatments for safety and effectiveness. Participants in the clinical trials must meet specific eligibility criteria and provide informed consent, which allows them potential access to innovative therapies while contributing to medical advancements.

Short Summary

Clinical trials are research studies conducted with human participants to evaluate the safety, efficacy, and optimal use of new medical treatments or interventions.
Clinical trials progress through phases (I to IV) to evaluate the safety, efficacy, and long-term effects of new treatments on human participants.
Clinical trials are closely monitored by independent committees to ensure participant safety and study integrity, helping to protect those involved throughout the research process.

What Are Clinical Trials?

Clinical trials are research studies where researchers assign participants to receive one or more interventions to observe their effects on individuals. For this reason, they are also known as interventional studies.

Clinical trials help find answers to specific health questions, serving as the safest and fastest method for developing new treatments. Each trial follows a detailed protocol outlining participant eligibility, treatment procedures, dosages, and objectives. They aim to assess the safety and effectiveness of new drugs or devices, explore improved usage of existing treatments, and include diverse populations to enhance health equity.

Fig. 1: Features of Clinical Trials

Regulations and Regulatory Bodies in Different Countries

Navigating clinical trials involves understanding the regulations and guidelines that govern the conduct of these trials in different countries. Each country has its own regulatory bodies and requirements to ensure the safety, efficacy, and ethical conduct of clinical research. Some of the regulatory bodies include:

Food and Drug Administration (FDA):

The FDA oversees clinical trials in the U.S. through its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for drugs and biologics, respectively. Before initiating clinical research, drug developers, also known as sponsors, must submit an Investigational New Drug (IND) application to the FDA. This application includes several key components:
Data from animal studies, including information on toxicity and potential adverse effects.
Details about the manufacturing process.
Clinical protocols that outline the planned studies.
Results from any prior human research.
Information about the principal investigator.

Clinical trials must comply with Good Clinical Practice (GCP) and be approved by an Institutional Review Board (IRB). Informed consent is mandatory.

European Medicines Agency (EMA):

The EMA is responsible for the coordination of clinical trials across European Union (EU) member states. Each member state also has its own national regulatory body. Clinical trials in the EU must follow GCP guidelines, and the Clinical Trials Regulation (EU) No 536/2014 governs clinical trials across EU member states. Informed consent and ethical committee approval are required.
Central Drugs Standard Control Organization (CDSCO):

The CDSCO, under the Ministry of Health and Family Welfare, governs clinical trials in India. India follows GCP guidelines, and clinical trials must be registered with the Clinical Trials Registry – India (CTRI). Ethical guidelines are governed by the Indian Council of Medical Research (ICMR) and include specific rules for vulnerable populations like children and pregnant women. Informed consent must be obtained from participants.
Pharmaceuticals and Medical Devices Agency (PMDA):

The PMDA govern the clinical trials in Japan, with compliance with GCP standards based on the International Council for Harmonisation (ICH) guidelines. Trials must be approved by an institutional ethics committee and follow Ministry of Health, Labour and Welfare (MHLW) guidelines.
Health Canada:

Clinical trials in Canada are regulated by Health Canada and must follow GCP guidelines. The regulatory process includes submission of a Clinical Trial Application (CTA), with ethics review and informed consent is essential.
National Medical Products Administration (NMPA):

Clinical trials in China are regulated by the NMPA. Trials must comply with the GCP standards based on the ICH GCP. Informed consent is required, and the ethics committee plays a central role in ensuring the trial meets ethical standards.

While clinical trial regulations vary by country, they all emphasize adherence to ethical standards, GCP guidelines, and the protection of participant rights.

Phases of Clinical Trials

Clinical trials are a complex process involving several steps, beginning with an initial idea and culminating in the implementation and sharing of results.

Each phase of the clinical trial process requires careful planning and collaboration among various stakeholders to ensure success. Different phases of clinical trials include:

	Phase I	Phase II	Phase III	Phase IV
Aim	To evaluate the safety and identification of side effects of new treatment	To evaluate efficacy and assess the safety of the new treatment	To confirm efficacy, monitor side effects, collect information on its safe use, and to compare with similar or standard treatments	To assess safety and collect information on its optimal use and benefits. Made available to the public after approval by the Regulatory Body
Participants	20-80 participants	100-300 participants	1000-3000 participants	1000+ participants
Length of Study	Several months	Several months – 2 years	1-4 years	–

Table 1: Phases of Clinical Trial

Together, these phases (from Phase I – Phase IV) ensure that new treatments are both safe and effective before reaching the public.

How Can CliniExperts Help?

Clinical trials are recognised as a costly component of drug and treatment development within the pharmaceutical industry. These trials demand significant resources and involve repetitive, often tedious tasks for data collection, analysis, and verification. Therefore, meticulous management is essential to ensure the integrity and accuracy of the data generated. Effective planning at every stage is crucial, and this can only be achieved with the expertise of highly trained professionals.

Fig. 2: Why You Should Outsource Clinical Trials

Outsourcing clinical trial management to CliniExperts offers a cost-effective solution for small to mid-sized pharmaceutical, biotech, and device companies. All facets of the clinical trial process on behalf of clients are effectively managed, including:

Site Selection: Potential sites are assessed using the Site Attractiveness Index (SAI), which considers factors like subject recruitment potential, principal investigator experience, and trained site staff. This ensures that study targets and timelines are reliably met.
Monitoring Services: Monitoring is done by highly experienced and professionally trained personnel, ensuring top-notch oversight throughout the trial.
Safety Monitoring Services: With extensive industry experience, the medical monitoring team focuses on safety review and reporting within clinical trials.
Project Management Services: Project managers and specialists diligently monitor project and site performance during the trials, ensuring everything runs smoothly.
Data Management Services and Case Study Reporting (CSR): Comprehensive services, including Case Report Form (CRF) design, database creation, statistical analysis, and medical report writing are provided. These customisable data management systems are tailored to meet specific trial needs and budget considerations, all while maintaining high quality and efficiency at competitive prices.
Post-Marketing Surveillance/Phase IV Studies: Extensive post-marketing surveillance observational studies are conducted across all therapeutic areas, which include protocol writing, CRF design, investigator selection, patient enrolment, CRF evaluation, and report writing.
Clinical Investigation and Clinical Performance Evaluation for Medical Devices and IVDs

With CliniExperts, you can navigate clinical trials with confidence and efficiency, ensuring your research meets the highest standards.

Conclusion

Navigating clinical trials can be challenging, but partnering with CliniExperts Research Services can significantly streamline the process. With expertise in trial design and regulatory compliance, CliniExperts provides invaluable guidance to help optimise your study protocols. Their focus on effective site selection and management ensures access to the right patient populations, while advanced recruitment strategies enhance patient enrolment and retention, both critical for timely trial completion.

Additionally, CliniExperts offers robust data management solutions and regulatory support to ensure compliance and accuracy in your study. By leveraging the latest technologies and providing customised services, they help reduce costs associated with delays and inefficiencies. Overall, their comprehensive support can accelerate your clinical trial and improve the quality of your research outcomes.

References

CTG Labs – NCBI [Internet]. clinicaltrials.gov. 2023. Available from: https://clinicaltrials.gov/study-basics/learn-about-studies
Basics About Clinical Trials [Internet]. U.S. Food and Drug Administration. 2019.

Available from: https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials

Center for Drug Evaluation and Research | CDER [Internet]. FDA. 2020.

Available from: https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder

Center for Biologics Evaluation and Research (CBER) [Internet]. FDA. 2020.

Available from: https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber

FDA. Step 3: Clinical Research [Internet]. U.S. Food and Drug Administration. 2018.

Available from: https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

Clinical Trials Regulation | European Medicines Agency [Internet]. www.ema.europa.eu.

Available from: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation

home [Internet]. Cdsco.gov.in. 2020.

Available from: https://cdsco.gov.in/opencms/opencms/en/Home/

Frequently Asked Questions (FAQ) | Pharmaceuticals and Medical Devices Agency [Internet]. www.pmda.go.jp.

Available from: https://www.pmda.go.jp/english/about-pmda/0004.html

Clinical Research Regulation For Canada | ClinRegs [Internet]. clinregs.niaid.nih.gov.

Available from: https://clinregs.niaid.nih.gov/country/canada

Clinical Research Regulation For China | ClinRegs [Internet]. clinregs.niaid.nih.gov.

Available from: https://clinregs.niaid.nih.gov/country/china#regulatory_authority

Navigating Clinical Trials | Office for Clinical Research Advancement [Internet]. ocra.fsu.edu. Available from: https://ocra.fsu.edu/study-support-services/clinicaltrialsgov-administration/navigating-clinical-trials/
Clinical Trial [Internet]. CliniExperts.

Available from: https://cliniexperts.com/clinical-trial/

Understanding Consumer Claims for Clinical Trials

Mon, 02 Dec 2024 11:21:04 GMT

Understanding Consumer Claims for Clinical Trials

Overview

Effective clinical trial solutions are crucial for food, supplement, and cosmetic brands to validate product claims, ensuring both safety and efficacy. By utilising expert services, companies can build consumer trust, meet regulatory requirements, and gain a competitive advantage in the marketplace.

Short Summary

Understanding consumer claims for clinical trials involves ensuring transparency and allowing participants to grasp the purpose, risks, and benefits of new products.
Regulatory bodies like the oversee these trials to protect consumer safety and ensure ethical practices.
Product claims must be substantiated by clinical trials to ensure their credibility and meet consumer expectations. Also, this helps to justify the claims from the regulatory front and can be used for claim approval perspective as well.

Introduction

In today’s competitive market, the safety and efficacy of products are essential for gaining consumer trust and ensuring regulatory compliance. The potency of any product relies on its composition and the quality of its ingredients, validated through rigorous clinical trials and studies.

This process is crucial for food and dietary supplements, which require robust efficacy evaluations to confirm their clinical benefits.

Similarly, cosmetics aimed at enhancing skin, hair, scalp, nail, and oral health must also demonstrate specific benefits that support their packaging and label claims. Understanding and validating these aspects not only helps meet market demands but also ensures that products deliver on their promises through scientific evidence.

What Are Clinical Trials?

Clinical trials are structured research studies in which volunteers participate to help get answers to specific health-related questions and contribute to the development of new treatments.

These trials follow a detailed protocol that outlines participant eligibility, testing schedules, drug dosages, study duration, and research objectives. Participants must agree to the protocol, and researchers must adhere to strict regulations set by the CDSCO, FSSAI, ICMR, and Ethics committee ensuring participant safety throughout the study.

The primary aims of clinical trials include evaluating the safety and efficacy of new drugs or devices, exploring alternative applications of existing treatments, and ensuring diverse populations are represented in medical research. Participants may choose to enrol in trials when standard treatments are ineffective or to aid in medical advancement.

Trials occur in various locations, including hospitals and research centres, and the Ethics committee oversees the process to protect participants. Before joining, individuals are encouraged to understand the trial’s specifics and product claims, including potential risks and benefits, and consult their healthcare providers.

Fig. 1: Primary Aim of Clinical Trials

Understanding Product Claims

Product claims are statements made by manufacturers/marketers about the benefits or characteristics of their products, primarily in the food, dietary supplement, and cosmetic industries. This involves a deep understanding of both the products and the regulatory landscape to ensure that all claims are valid and substantiated.

Product claims can be categorised into several categories:

Risk Deduction Claims:

Risk reduction claims refer to statements made by manufacturers or marketers suggesting that a product can lower the risk of developing certain diseases or health conditions. These claims often imply that the product can contribute to preventive health measures.
Functional Claims:

Functional claims refer to statements that highlight a product’s specific benefits or effects on health or body functions, such as improving digestion or enhancing energy levels. These claims must be supported by scientific evidence and research to ensure accuracy and credibility.
Nutritional and Health Benefits Analysis:

This involves examining the health benefits offered by a particular product, ingredient or nutrient. It may or may not include bioavailability of nutrients and the processes used in manufacturing such as unique technology. Rigorous clinical trials and studies are conducted to ensure that all nutritional claims are accurate and substantiated.
Immunity and Anti-ageing Claims:

Immunity claims assert that a product enhances or supports immune function, while anti-ageing claims suggest that a product reduces the signs of ageing or promotes a youthful appearance, both requiring scientific backing for validity.
SPF, UVA/UVB Analysis:

SPF, UVA, and UVB analysis involves evaluating cosmetic products to determine their effectiveness in shielding the skin from harmful ultraviolet radiation. This includes conducting evaluations of sun protection products such as lotions, gels, and creams.
Glycaemic Index (GI) Analysis:

Measures how quickly a food or supplement causes blood sugar levels to rise. Comprehensive GI assessments should be performed across different food matrices, providing valuable insights into the effects of various products on blood glucose levels.
Health Maintenance Claims:

This pertains to the maintenance of overall health, skin, hair, or body, and requires robust clinical trial backing.

Fig. 2: Different Types of Product Claims With Examples

Overall, these claims need to be supported through rigorous research and clinical trials, ensuring compliance with regulatory standards and accuracy in marketing communications before they are implemented.

How Can CliniExperts Help?

CliniExperts enhances your brand value through specialised clinical trial solutions tailored for food, cosmetics, and cosmeceutical products. With a proven track record of conducting successful trials for over 45 renowned brands and validating more than 123 consumer claims, CliniExperts can offer comprehensive services that include efficacy evaluation, safety assessments, and customised solutions for specific product needs.

Our expert team ensures that your product claims are scientifically substantiated, helping to build trust with consumers and strengthen your market position.

In addition to efficacy and safety evaluations, CliniExperts provides in-depth analyses for various claims, including but not limited to SPF, glycaemic index, and health benefits. Our advanced research tools and methodologies enable us to deliver precise results that support your product’s labelling and marketing strategies.

By partnering with CliniExperts, you gain access to our extensive expertise and resources, allowing you to navigate the complexities of clinical trials confidently and enhance your product offerings effectively.

Conclusion

Robust clinical trial solutions are essential for food, supplement, and cosmetic brands to validate product claims, enhance consumer trust, and ensure compliance with regulatory standards. These trials not only confirm the efficacy and safety of products but also provide critical data that supports marketing strategies and improves consumer loyalty.

By investing in scientifically substantiated claims, brands can differentiate themselves in a competitive market, driving growth and fostering long-term relationships with customers. Ultimately, thorough clinical evaluation serves as a foundation for innovation and responsible product development in the industry.

With their extensive expertise and customised approach, CliniExperts can help brands navigate the complexities of clinical trials, ensuring that their product claims are scientifically validated and effectively communicated to consumers.

References

Rogeaux M. Consumer understanding and reaction to health claims: insights and methodology [Internet]. Jaeger SR, MacFie H, editors. ScienceDirect. Woodhead Publishing; 2010. p. 277–302. Available from: https://www.sciencedirect.com/science/article/abs/pii/B9781845695675500101
Consumer Claims [Internet]. CliniExperts Research. 2024. Available from: https://cliniexperts-research.com/clinical-trial-india/consumer-claims/
Basics About Clinical Trials [Internet]. U.S. Food and Drug Administration. 2019. Available from: https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials

Data Management and Analysis: The Backbone of Successful Clinical Trials

Mon, 25 Nov 2024 09:00:42 GMT

Data Management and Analysis: The Backbone of Successful Clinical Trials

Overview

Data management and analysis are crucial for successful clinical trials, ensuring data integrity, regulatory compliance, and timely insights. They enable efficient workflows, facilitate real-time monitoring, and support adaptive trial designs, ultimately enhancing the reliability of trial outcomes and advancing medical research.

Short Summary

Reliable data collection and management systems for clinical trials ensure accurate and consistent data, which is crucial for trial validity.
Employing appropriate statistical methods and conducting interim analyses help interpret trial results effectively and inform necessary adjustments throughout the study.
Adhering to regulatory guidelines and implementing strong data security measures protect patient confidentiality and ensure the integrity of the trial process.

Introduction

Clinical trials are studies that involve participants who are given one or more interventions to examine the outcomes produced by the treatments. These trials are critical in determining the safety and efficacy of new treatments and represent the safest and fastest way to develop them.

Effective data management and thorough analysis are essential to ensure successful outcomes. Each trial adheres to a detailed protocol that specifies participant eligibility, treatment procedures, dosages, and objectives.
The primary goals of these studies are to evaluate the safety and effectiveness of new drugs or devices, explore enhanced uses of existing treatments, and include diverse populations to promote health equity.

While FDA regulations safeguard participant safety, it’s essential for potential participants to have thorough discussions with their healthcare providers to understand all aspects of the trial, including risks, benefits, and costs. The FDA oversees the approval of new treatments, ensuring the integrity of the research process.

Data Management in Clinical Trials

Clinical Data Management (CDM) is crucial for preserving data integrity throughout research. It ensures that datasets are accurate, secure, reliable, and ready for analysis. A CDM team systematically collects, enters, cleans, and processes information obtained during clinical research, guaranteeing the accuracy, completeness, and consistency of trial data while adhering to regulatory standards.
The primary objective of CDM is to validate and ensure the reliability of data, preparing it for regulatory submission and subsequent analysis. This function serves as the backbone for producing high-quality, statistically sound results that guide medical decisions and facilitate regulatory approvals.

Fig. 1: Why Is Clinical Data Management (CDM) Important?

Regulatory compliance is a core aspect of CDM, ensuring that all collected data meets the rigorous standards set by authorities. These electronic records must comply with the Code of Federal Regulations (CFR), specifically 21 CFR Part 11. Key regulatory guidelines and standards that are critical for ensuring the integrity, privacy, and quality of clinical trial data include:

Good Clinical Data Management Practices (GCDMP): Best practices for managing clinical data quality and integrity.
International Council for Harmonisation – Good Clinical Practice (ICH-GCP) – ICH (E6 R2): Global standards for ethical and scientific quality in clinical trials.
Clinical Data Interchange Standards Consortium (CDISC) Standards: Data exchange and submission standards for clinical trial data.
General Data Protection Regulation (GDPR): Regulations for protecting personal data, relevant in European clinical trials.
Health Insurance Portability and Accountability Act (HIPAA): Regulations ensuring the privacy and security of health data.

By maintaining comprehensive records and implementing stringent validation processes, CDM not only supports the approval of new treatments but also upholds the integrity of the research. The emphasis on data quality is critical, as it directly influences the credibility of research outcomes.

High-quality data is essential for ensuring that the results of clinical trials are statistically sound and reliable, providing a strong foundation for medical decisions and advancing patient care.

The objectives of Clinical Data Management are to:

Ensure data quality and integrity
Maintain compliance with regulatory standards
Manage data collection effectively
Facilitate accurate analysis and reporting

The Clinical Data Manager plays an important role in the success of clinical trials, overseeing all aspects of data collection, validation, and analysis. By adhering to industry standards and regulatory requirements, they help ensure the integrity of trial data, contributing to the ultimate goal of providing safe and effective treatments to patients.

The CDM team offers a comprehensive range of services to support the entire data management lifecycle for clinical trials, including study start-up activities, protocol review, development of the Data Management Plan (DMP), CRF design and development, database setup, data collection and monitoring, data quality and compliance oversight, data analysis and reporting, data extraction and coding, database lock, and data reconciliation.

These services are designed to ensure efficient and accurate data management throughout the trial process. Ultimately, a robust Clinical Data Management process is indispensable for advancing healthcare and fostering innovation within the life sciences sector.

Data Analysis in Clinical Trials

The Clinical Data Manager is responsible for overseeing data collection, cleaning, and basic transformation, ensuring the accuracy, consistency, and regulatory compliance of the data. While the CDM prepares datasets for analysis, they do not engage in statistical data modelling.

Data modelling, statistical analysis, and interpretation are handled by the biostatistician. Using advanced statistical methods, the biostatistician derives insights that inform clinical decision-making. Together, the CDM and biostatistician collaborate closely to ensure the integrity and quality of data analysis throughout the clinical trial process.

This collaborative approach is critical in clinical trials, where data analysis plays a vital role in assessing the safety and efficacy of new treatments. The process begins with a carefully designed study, incorporating randomization and blinding to minimize bias. Data is collected on primary and secondary endpoints using clinical assessments and lab tests.

Statistical analysis follows, using descriptive statistics to summarise data and inferential statistics to test hypotheses, including survival analysis for time-to-event data. Interim analyses may be conducted to evaluate results and potentially terminate the trial early for safety or efficacy.
Maintaining data integrity through rigorous management practices is crucial, often involving electronic data capture systems. Compliance with regulatory standards from organisations like the FDA ensures transparency. Results are reported clearly and post-trial analyses may explore long-term outcomes. Ultimately, effective data analysis is vital for validating findings and guiding clinical practice.

Fig. 2: Steps of Data Analysis in Clinical Trials

How Can CliniExperts Help With Data Management and Analysis?

Data management and analysis are the backbone of clinical trials, ensuring that findings are reliable and actionable. CliniExperts enhances data management and analysis by providing a centralised platform that streamlines data collection and storage.

With advanced electronic data capture systems, the risk of manual entry errors is minimised, ensuring accurate and efficient data gathering. This centralised approach not only protects data integrity but also facilitates real-time updates, making information easily accessible to all stakeholders. Additionally, CliniExperts ensures regulatory compliance, safeguarding against potential audit issues while adhering to industry standards.

Furthermore, CliniExperts employs robust analytical tools and data visualisation techniques that transform complex datasets into actionable insights. Real-time reporting capabilities enable stakeholders to monitor trial progress and address any emerging challenges promptly.

By fostering collaboration among research teams, CliniExperts promotes effective communication and the rapid exchange of insights, ultimately leading to more informed decision-making and improved clinical trial outcomes.

Conclusion

Clinical data management and analysis serve as the backbone of clinical trials, ensuring the integrity, accuracy, and reliability of trial outcomes. By meticulously collecting, organising, and interpreting data, these processes enable researchers to make informed decisions, uphold regulatory standards, and ultimately enhance patient safety and efficacy of new treatments.

As the landscape of clinical research evolves with technological advancements, the importance of robust data management and sophisticated analytical techniques will only continue to grow, paving the way for more innovative and effective healthcare solutions.

By partnering with CliniExperts, organisations can leverage expert guidance and advanced data solutions, ensuring that their clinical trials are not only efficient but also yield high-quality results that drive successful outcomes.

References

CTG Labs – NCBI [Internet]. clinicaltrials.gov. 2023.
Available from: https://clinicaltrials.gov/study-basics/learn-about-studies
Basics About Clinical Trials [Internet]. U.S. Food and Drug Administration. 2019.
Available from: https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials
Krishnankutty B, Naveen Kumar B, Moodahadu L, Bellary S. Data management in clinical research: An overview. Indian Journal of Pharmacology [Internet]. 2012;44(2):168.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/
Statistical Data Analysis [Internet]. Ct-toolkit.ac.uk. 2017.
Available from: https://www.ct-toolkit.ac.uk/routemap/statistical-data-analysis
Charles H. Evans J, Ildstad ST. Statistical Approaches to Analysis of Small Clinical Trials [Internet]. www.ncbi.nlm.nih.gov. National Academies Press (US); 2001.
Available from: https://www.ncbi.nlm.nih.gov/books/NBK223333/
Clinical Trial [Internet]. CliniExperts.
Available from: https://cliniexperts.com/clinical-trial/

Key Considerations for Designing a Successful Clinical Investigation for Medical Devices

Mon, 11 Nov 2024 11:35:23 GMT

Key Considerations for Designing a Successful Clinical Investigation for Medical Devices

Short Description

For a medical device to be effective and successful, it needs to go through medical device clinical trials. Clinical investigation for medical devices are indispensable in ensuring the safety and efficacy of medical devices so they meet regulatory requirements and become a part of healthcare technologies.

They are not just about gathering data; they provide assurance for regulatory approval and give healthcare professionals confidence in the devices’ safety and performance. There’s a lot involved in designing a successful medical device clinical trial. To understand clinical trials in India, we suggest reading the following post.

A Quick In-Depth to Medical Device Clinical Trials

Medical device clinical trials constitute rigorous testing and evaluation of medical equipment before they are made available to be performed on human subjects. They require systematic study of the device’s performance, safety, and potency in a controlled environment.

Clinical investigations follow the strict guidelines and protocols laid out by the regulatory bodies, as compliance with them is non-negotiable. The trials are conducted in multiple phases, from the small, controlled group to large-scale individuals.

The magnitude of medical device clinical trials doesn’t end here; these investigations help identify any risks or challenges associated with device usage, giving manufacturers a window to rectify the issues before seeking approval.

Different Phases of Clinical Investigation for Medical Devices

The clinical trials for medical devices are classified into various stages:

Phases	Explanation
Pilot Studies	Pilot studies for medical devices are conducted on a small population who have the condition or disease being studied. These studies aim to provide initial insights into the device’s performance and safety on subjects.
Pivotal Studies	Pivotal studies involve testing medical devices in a large population to obtain conclusive evidence of the device’s safety and effectiveness for intended use.
Post-market Surveillance Studies	Post-market surveillance studies are done to monitor the device’s performance and safety on participants after the device is marketed to confirm its long-term safety and performance.

Key Elements of Medical Device Clinical Trial Design

A crucial part of clinical trials is the study design, which establishes the methodology and data collection. The protocol ensures uniformity and strict standardization in the research process by outlining the objectives, methodology, goals, and statistical analysis strategy for the experiment.

Failing short on any of those could result in device manufacturers producing low-quality data. Let’s take a look at make-or-break factors in medical device clinical investigations that are fundamental in advancing patient care.

Sample Size

Think of sample size as one of the foundations of a medical device clinical trial process, as an incorrect sample size can produce unreliable conclusions, either by giving false positives or by failing to detect a true defect in the medical device. This could make the entire trial invalid. Suppose the sample size is too small; the trial may not have the statistical power to ensure the medical device’s efficacy.

Conversely, if the sample is larger than required, it could lead to a waste of resources without producing useful data. Hence, it is highly crucial to carefully do the sample size calculation based on the device’s required population size for the expected performance.

Primary and Secondary Endpoints

In a clinical trial, the primary endpoint is the main measure used to assess the effectiveness of the device being tested. Secondary endpoints, on the other hand, offer additional information about the device’s impact and how it works. It is essential to clearly define both primary and secondary endpoints in advance, within the trial’s protocol, to ensure accurate and r0eliable results.

Blinding

Blinding plays a quintessential role in medical device clinical investigations by reducing measurement bias, but it also comes with ethical and practical difficulties. When blinding isn’t possible, the alternative approach is to have the trial outcomes evaluated by experienced and certified people who are blind to the treatment details, which will ensure objective assessment.

Fig. 1: Important Constituents of a Clinical Trial Design for Medical Devices

Clinical Trial Team

Since many manufacturers don’t have in-house clinical trial personnel, they prefer outsourcing services from CRO companies. A dedicated clinical research organization (CRO) helps manufacturers with their medical device investigations through protocol development, statistical analysis, data management, regulatory affairs, and other clinical trial aspects.

For a medical device clinical trial to be performed successfully and with perfection, manufacturers must remember to validate the experience of the CRO in medical devices or fields related to the same before proceeding with the investigations, so the reports are delivered on scientific grounds.

Skill Level and Training of the User

When planning a medical device investigation, it’s essential to take into consideration the skill set required for the safe intended use of the device. The expertise of study investigators should reflect the skill set of the intended user when the market sets foot in a real-world setting.

Additionally, the hands-on training provided to the trial team in the pivotal study should also be provided in the post-market setting. Some medical devices require considerable training to use the device safely and properly. For instance, medical implants require a specific skill set of a trained surgical specialist, especially when the use of the device is complex (1).

If the marketed device does not require any formal training, then the study personnel should also not be trained specifically for the device’s operations to ensure accurate results similar to post-market usage conditions.

Control Group Selection

Assembling the right control group is critical to the success of a medical device clinical investigation. Depending on the medical device’s nature as well as ethical considerations, the control group could range from a standard treatment group to a placebo group or a sham group.

Methods of Evaluation

For a clinical trial to be factual and transparent, the use of appropriate statistical methods is vitally important. Correct statistical approaches warrant that any differences observed between control groups in the trial are statistically concrete and not due to chance. Employing varied statistical analyses under various assumptions can help provide reliable results.

However, there’s a catch. Too much insistence on data collection through various statistical analyses can overwhelm the clinical staff, such as clinical investigators, nurses, and coordinators. This is commonly observed in early-stage companies and those with massive R&D budgets.

Fig. 2: Key Objectives of Medical Device Clinical Trials

Takeaway

Embarking on a clinical investigation for medical devices is a journey that requires precision and expertise at every step of the way. Here’s what we learned:

The clear and sound objectives and hypothesis of the clinical investigation is important for establishing a statistical analysis plan.

Medical device clinical trials involve effective enrollment strategies, data collection and management, and quality control.

Responsible clinical trials must be conducted within ethical considerations with strict adherence to guidelines laid by regulatory bodies.

The CDSCO and CLA are the regulatory bodies for medical device clinical trials in India.

All medical devices belonging to classes B, C, and D require medical device clinical investigation.

Successful clinical investigations for medical devices require meticulous planning, closely working with regulatory bodies, hundreds of hours of manpower, and adherence to the best practices—all to have safe and effective use of the devices in real-world usage conditions.

Although the process is complex, it is rewarding in the long term, ensuring the flow of cutting-edge technologies in the market and safeguarding the health of millions of people.

Reference

Design Considerations for Pivotal Clinical Investigations for Medical Devices; FDA; https://www.fda.gov/media/87363/download; November 2013

Drug Clinical Trials and Approval in India

Tue, 06 Aug 2024 10:45:45 GMT

Drug Clinical Trials and Approval in India

Short Description

The approval process for new drugs clinical trials in India can be tricky. The roles of various regulatory authorities are crucial in ensuring high quality and well-researched products reach the consumers. Here’s a step-by-step guide.

Introduction

The drug approval process in India involves getting authorisation from various authorities. This includes stages like application for clinical trials for drugs, conducting trials, applying for marketing authorisation, and conducting post-marketing studies.

Each country has a regulatory authority to enforce rules and issue guidelines to companies seeking to launch their drugs in the market. The approval of new drugs and drug clinical trials in India is a thorough process overseen by several regulatory bodies like the CDSCO, DCGI, etc. This ensures the safety, efficacy, and quality of drugs and clinical trials for drugs.

Regulatory Bodies Overseeing Drug Clinical Trials in India

Understanding the regulatory bodies involved in drug clinical trial services in India is crucial to navigate the approval process. These organisations enforce strict regulations and guidelines to maintain the highest standards of drug safety and efficacy. The main regulatory bodies involved include:

Central Drugs Standard Control Organization (CDSCO): The CDSCO, operating under the Ministry of Health and Family Welfare, is the main regulatory body overseeing the approval of new drugs and drug clinical trials in India. It ensures adherence to national standards.
Drugs Controller General of India (DCGI): The DCGI, an official within the CDSCO, is responsible for approving new drugs and clinical trials. This role is crucial in ensuring the integrity and safety of drug clinical trial services.
Drugs Technical Advisory Board (DTAB): It comprises of special experts who advise the central and state governments on all matters related to drug control enforcement. This board is crucial for central government decision-making, as no rules can be made without consulting the DTAB.
Drugs Consultative Committee: It includes central members and state drug control officers. Its primary role is to ensure uniform application of drug control measures across the country.
Genetic Engineering Approval Committee (GEAC): It oversees the approval process for r-DNA medicinal products and assesses the bio-safety and environmental impact of biotechnological products to ensure safety standards are upheld.
Indian Council of Medical Research (ICMR): It conducts evaluations and provides critical appraisal alongside subject expert committees for conducting clinical trials, as well as for the import, manufacture, and sale of new drugs overseen by the CDSCO.
Institutional Review Boards (IRBs) and Ethics Committees: IRBs and Ethics Committees play a crucial role in reviewing and approving the ethical aspects of clinical trials at local levels. They ensure that the rights and welfare of participants are protected.

Regulatory Body	Role
CDSCO	Oversees drug approval and clinical trials, ensuring national compliance standards are met.
DCGI	Approves new drugs and clinical trials, ensuring the safety and integrity of trials and medications.
DTAB	Advises on drug control enforcement, influencing regulatory policies for effective governance.
Drugs Consultative Committee	Ensures consistent application of drug control measures across India, promoting uniformity in regulations.
GEAC	Approves r-DNA medicinal products and monitors biotechnological product safety to uphold bio-security standards.
ICMR	Provides scientific evaluation and ethical oversight for clinical trials and drug approvals, ensuring research integrity.
IRBs and Ethics Committees	Review and approve ethical aspects of clinical trials, safeguarding participant rights and ensuring ethical conduct in research.

Table 1: Key Regulatory Bodies and Their Roles

Approval Process of Clinical Trials for Drugs

The approval process for drug clinical trials in India can be tedious, time-consuming and expensive. This procedure involves multiple stages of review and evaluation by the afore discussed regulatory bodies. Here’s a brief overview of the steps:

Application Submission: Companies who want to conduct a clinical trial for a drug must submit a detailed application to the CDSCO, including preclinical data and proposed study protocols.
Review and Evaluation: The CDSCO reviews the application, evaluates the scientific validity, and assesses the potential risks and benefits of the clinical trials for drugs.
Ethical Approval: Simultaneously, IRBs and Ethics Committees review the study protocols to ensure ethical standards are met. This step is crucial for protecting participant rights.
Approval and Monitoring: Upon approval, the DCGI grants permission to conduct the clinical trial. Continuous monitoring ensures compliance with regulatory standards throughout the study.

Fig 1: Approval Process of Clinical Trials for Drugs

Steps to Ensure Compliance During Regulatory Approval

Ensuring compliance during drug clinical trial services is critical to uphold safety of participants and keep up efficacy standards for new treatments in the healthcare sector. A few key points to keep in mind are:

Good Clinical Practice (GCP): All clinical trials must adhere to GCP guidelines, ensuring ethical and scientific quality standards in the conduct, reporting and design of clinical trials.
Regular Inspections: Regulatory authorities conduct regular inspections of clinical trial sites to ensure compliance with approved protocols and guidelines.
Adverse Event Reporting: Investigators are required to report any adverse events promptly. This allows for timely intervention and ensures participant safety.

Fig 2: Steps to Ensure Compliance During Regulatory Approval

Conclusion

The approval process for drug clinical trials in India is methodically supervised by regulatory bodies ensuring that new medications meet demanding standards of safety. Through systematic review and ethical oversight, the process aims to safeguard participant welfare and uphold public trust in clinical research.

This regulatory framework underscores India’s commitment to advancing drug clinical trial services and facilitating the development of innovative treatments for diverse healthcare needs.

Summary

The drug approval process in India involves multiple difficult stages starting from four phases of clinical trials up to post-marketing studies, overseen by multiple regulatory bodies.
Key regulatory bodies include the CDSCO, DCGI, DTAB, GEAC, ICMR, and IRBs/Ethics Committees, each playing a crucial role in ensuring drug safety and efficacy.
The CDSCO oversees drug approval and clinical trials, maintaining national compliance standards.
The DCGI approves new drugs and clinical trials, ensuring safety and integrity throughout.
IRBs and Ethics Committees safeguard participant rights by reviewing ethical aspects of clinical trials.
Compliance measures like Good Clinical Practice (GCP) and regular inspections uphold safety standards during regulatory approval.

References

1. Gogtay, Nithya J; Ravi, Renju; Thatte, Urmila M. Regulatory requirements for clinical trials in India: What academicians need to know. Indian Journal of Anaesthesia 61(3):p 192-199, March 2017. | DOI: 10.4103/ija.IJA_143_17 Available from: https://journals.lww.com/ijaweb/fulltext/2017/61030/regulatory_requirements_for_clinical_trials_in.2.aspx
2. Gupta, N. Vishal & CR, M & KP, R & Ajay, K & HG, S. (2012). Process of approval of new drug in India with emphasis on clinical trials. International Journal of Pharmaceutical Sciences Review and Research. 13. 17-23. Available from: https://ijprajournal.com/issue_dcp/New%20Drug%20Approval%20Process%20in%20India%20Emphasis%20on%20Clinical%20Trials.pdf
3. Handbook for Applicants and Reviewers of Clinical Trials of New Drugs in India. [Internet] Indian Council of Medical Research [cited 2024 July 1st]. Available from: https://main.icmr.nic.in/sites/default/files/reports/Handbook%20for%20Applicants%20and%20Reviewers%20of%20Clinical%20Trials.pdf
4. Ethics Committee. [Internet] National Institute of Allergy and Infectious Diseases [cited 2024 July 1st]. Available from: https://clinregs.niaid.nih.gov/country/india#ethics_committee
5. Institutional Review Board. [Internet] Oregon State University [cited 2024 July 1st]. Available from: https://research.oregonstate.edu/irb/what-institutional-review-board-irb#:~:text=The%20Institutional%20Review%20Board%20(IRB)%20is%20an%20administrative%20body%20established,with%20which%20it%20is%20affiliated.
6. Draft Guidance on Approval Of Clinical Trials & New Drugs. [Internet] Central Drugs Standard Control Organization [cited 2024 July 1st]. Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadAlertsFiles/Guidance_for_New_Drug_Approval-23july2.pdf

Clinical Trials in India

Tue, 06 Aug 2024 10:45:06 GMT

Clinical Trials in India

Short Description

Enrolling in clinical trials in India can offer participants access to cutting-edge treatments while contributing to medical research. This article provides a step-by-step guide on how to enroll in clinical trials in India.

What are Clinical Trials?

Clinical trials for drugs are research studies performed on human participants to evaluate surgical, behavioral or medical interventions. They are the main methods researchers use to determine whether new treatments are safe and effective.

1- The drug clinical trials in India are regulated by the Department of Central Drugs Standard Control Organization (CDSCO), part of India’s Ministry of Health, which is the national regulatory authority ensuring the safety, efficacy, and quality of drugs, medical devices and cosmetics.

2- Enrolling in clinical trials in India provides the participants access to advanced treatments and contributes to medical research. Here’s a concise guide on how to participate in a clinical trial.

Finding Clinical Trials for Drugs

The initial step is finding appropriate clinical trials in which you can participate. Various resources can assist in this process:

Fig 1: Resources Assist in Drug Clinical Trial in India

Clinical Trial Registries: Begin by searching websites like Clinical Trials Registry – India (CTRI) to list ongoing trials. It was launched on July 20, 2007, and is overseen by the ICMR-National Institute of Medical Statistics in New Delhi, India. It operates as a free, searchable online platform for the prospective registration of all clinical studies conducted in India.
Healthcare Providers: Doctors and healthcare professionals often have information about local trials. You can also discover studies through newspapers, TV, or online sources.
Join A Registry of Research Volunteers: Additionally, you can look for nonprofit programs connecting volunteers with researchers nationwide. One such example is Research Match built by the NIH and it aims at building a diverse database for comprehensive health studies.

Verify If You Are Eligible

You can search registered trials by entering relevant keywords in the search box of the database homepage. For drug clinical trials in India, visit CTRI website. Once you identify a clinical trial of interest, you can read up more about the study. Review the trial titles to shortlist and assess details to determine if participating is possible given their inclusion/exclusion criteria. Common criteria include:

Age and Gender: Specific age groups or gender.
Health Status: Presence or absence of certain medical conditions.
Medical History: Previous and current treatments or outcomes.

Contacting Trial Sites

Once you identify a clinical trial you’re interested in, reach out to the study team using the contact information provided in the trial’s description. They can provide more details to help you make an informed decision about participation in that trial. Inform your healthcare provider if you choose to participate in a clinical trial. They may communicate with the study team to coordinate your care and ensure the trial’s safety for you.

Enrolment Process of Clinical Trials for Drugs

The enrolment process for clinical trials is essential to ensure participant safety and research integrity. It helps researchers determine suitability and ensure informed participation. These steps include:

Fig 2: Enrolment Process of Clinical Trials for Drugs

Informed Consent: Investigators must ensure that they obtain written or verbal informed consent from all participants in a clinical trial. For trials involving vulnerable participants (such as children or mentally challenged patients) and a new chemical or molecular entity, investigators must also ensure that the informed consent process is audio-visually recorded.
Screening Tests: You may need to undergo medical tests to confirm if you meet the trial’s requirements. While investigators can discuss study availability and potential participation without an initial consent, informed consent is necessary before starting clinical procedures solely for research eligibility, such as medication withdrawal (wash-out). Procedures conducted as standard medical practice, regardless of study entry consideration, can be used to determine eligibility without prior consent.
Baseline Assessments: In clinical trials, understanding how baseline factors relate to treatment outcomes can improve our ability to detect treatment effects. Factors like initial severity or specific conditions at the trial’s start often influence how well treatments work. This insight is crucial, especially in addiction treatment research and community-based trials aimed at real-world effectiveness.

Step	Description
Find a Trial	Use registries, healthcare providers, and online platforms
Check Eligibility	Ensure you meet the trial’s inclusion criteria
Contact Site	Provide personal and medical information
Screening	Undergo tests to confirm eligibility
Informed Consent	Understand and sign the consent form
Baseline Assessment	Initial medical assessments and measurements

Pros and Cons of Participating

Drug clinical trial in India provide hope and opportunity for participants and researchers alike to discover new treatments. Healthy volunteers often participate to advance science and help others. Possible benefits of participating in a clinical trial include:

Receiving thorough medical care from a dedicated research team including doctors and healthcare professionals.
Participating in well-designed clinical trials offers personal benefits and helps advance medical knowledge.
Gaining early access to new treatments not yet widely available.

However, enrolling in clinical trials also comes with a few risks. Potential risks include:

Minor discomfort and occasional need for medical attention.
Frequent site visits, additional tests, procedures, hospital stays, or complex dosage schedules.
Rarely, serious or life-threatening complications from experimental treatments.

Conclusion

In summary, drug clinical trials in India provide participants with early access to new treatments and contribute to medical research under the regulation of the Central Drugs Standard Control Organization. These trials offer thorough medical care and the chance to advance healthcare options. However, participants should weigh potential risks, including minor discomfort or serious complications. Overall, drug clinical trial services play a vital role in enhancing healthcare by evaluating and introducing innovative treatments.

References

1. Clinical Trials. [Internet] National Institute of Mental Health [cited 2024 July 1st]. Available from: https://www.nia.nih.gov/health/clinical-trials-and-studies/what-are-clinical-trials-and-studies
2. Gogtay, Nithya J; Ravi, Renju; Thatte, Urmila M. Regulatory requirements for clinical trials in India: What academicians need to know. Indian Journal of Anaesthesia 61(3):p 192-199, March 2017. | DOI: 10.4103/ija.IJA_143_17. Available from: https://journals.lww.com/ijaweb/fulltext/2017/61030/regulatory_requirements_for_clinical_trials_in.2.aspx
3. Clinical Trials FAQs [Internet] Clinical Trials Registry India [cited 2024 July 1st]. Available from: https://ctri.nic.in/Clinicaltrials/faq.php#1a
4. Clinical Trials Information for Patients. [Internet] National Institute of Mental Health [cited 2024 July 1st]. Available from: https://www.nimh.nih.gov/health/trials
5. Evaluating Inclusion and Exclusion Criteria in Clinical Trials. [Internet] Food and Drug Administration [cited 2024 July 1st]. Available from: https://www.fda.gov/media/134754/download
6. Screening Tests. [Internet] Food and Drug Administration [cited 2024 July 1st]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/screening-tests-prior-study-enrollment
7. Nunes EV, Pavlicova M, Hu MC, Campbell AN, Miele G, Hien D, Klein DF. Baseline matters: the importance of covariation for baseline severity in the analysis of clinical trials. Am J Drug Alcohol Abuse. 2011 Sep;37(5):446-52. doi: 10.3109/00952990.2011.596980. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3260520/
8. Safety, Benefits and risks of clinical trials. [Internet] National Heart, Lung, and Blood Institute. [cited 2024 July 1st]. Available from: https://www.nhlbi.nih.gov/research/clinical-trials/safety-benefits-risks

Unveiled Clinical Trials For Drugs: Exploring Research for New Treatments

Fri, 19 Jul 2024 12:41:19 GMT

Unveiled Clinical Trials For Drugs: Exploring Research for New Treatments

Summary

Clinical trials for drugs are essential to ensure their safety and efficacy.
Drug trials usually progress through four phases: I, II, III, and IV.
India is an emerging hub for clinical trials due to its diverse population and cost-effectiveness.
Regulatory bodies like CDSCO ensure safety and compliance.
Challenges include regulatory delays and ethical concerns, but opportunities abound with government support and technological advancements.

Introduction

Clinical trials for drugs are a critical phase in the development of new medications. These trials ensure the safety and efficacy of new treatments before they become available to the public. This article explores the significance of drug clinical trials in India, highlighting phases, advantages, challenges, and regulatory aspects, aiming to enhance understanding and effectiveness in healthcare research.

Introduction to Clinical Trials

Clinical trials are research studies that investigate new tests and treatments to assess their impact on human health. Drug clinical trials in India refer to the methodical examination of a new drug in human subjects to gather data that validates its clinical, and pharmacological (including pharmacodynamic and pharmacokinetic).

The primary goal is to assess the safety and/or efficacy of the new drug. Individuals of all ages, including children, may be enrolled in these studies. However, before initiating clinical trials, the study needs to undergo meticulous design, review, and approval processes.

Clinical trials are heavily regulated and must be conducted in accordance with standard ethical guidelines, codes of conduct and national laws. This is to ensure participant safety, protection of human rights and privacy, good clinical practice, responsible research conduct, and quality data collection.

Phases for Clinical Trials for Drugs

Clinical trials for drugs typically go through four phases before they can be approved for use. Each phase serves a distinct purpose and assists researchers in addressing specific inquiries. These phases include:

Phase I

Objective: Assess safety, observe possible side effects and identify dosage range
Participants: 20-80 healthy volunteers

Phase II

Objective: Evaluate further safety and side effects
Participants: Up to 100-300 people with the disease and healthy volunteers

Phase III

Objective: Confirm efficacy, monitor side effects, compare to commonly used treatments
Participants: 1000-3000 volunteers with the disease

Phase IV

Objective: Conducted following the approval of the drug or treatment by the DCGI and its release for public use. Collect additional information after the drug is marketed
Participants: Several thousand volunteers with the disease

Phase	Objective	Participants
Phase I	Assess safety, observe possible side effects, and identify dosage range	20-80 healthy volunteers
Phase II	Evaluate further safety and side effects	Up to 100-300 people with the disease and healthy volunteers
Phase III	Confirm efficacy, monitor side effects, compare to commonly used treatments	1000-3000 volunteers with the disease
Phase IV	Conducted following the approval of the drug or treatment by the DCGI and its release for public use. Collect additional information after the drug is marketed.	Several thousand volunteers with the disease

Table 1: Overview of Clinical Trial Phases and Participants

Drug Clinical Trial Services in India

Clinical trials in India are governed according to the regulations outlined in the Drugs & Cosmetic Act of 1940 and its corresponding Rules from 1945. As of late, India has been recognised as a favourable location for clinical trials.

Advantages of drug clinical trials in India include:

Diverse Population: Offers a variety of genetic backgrounds
Cost-Effective: Lower operational costs compared to Western countries
Skilled Professionals: High availability of qualified medical professionals

Challenges Faced Clinical Trials for Drugs

Even though drug clinical trials are being conducted aplenty in India, they often encounter obstacles ranging from regulatory delays to operational complexities at trial sites. Some ethics and regulatory challenges faced along with suggestions are:

Ethics committee approvals are often delayed due to frequent meetings and procedural bottlenecks. To expedite decision-making for multicenter trials, streamlined processes that enable joint reviews by a designated ethics committee are essential.
This can reduce administrative hurdles and facilitate quicker approvals, ensuring the timely commencement of clinical research activities.
Operational challenges at trial sites, like infrastructure limitations, difficulties in participant recruitment, and focus on enhancing site capabilities.
Overcoming this involves improving digital infrastructure and implementing robust strategies to engage participants effectively. These efforts aim to optimize site operations and facilitate smoother conduct of clinical trials.
To resolve inconsistencies in ethics committee requirements and eliminate unnecessary reviews, implementation of standardised submission templates is essential.
Additionally, educating committees about exemptions available for non-regulatory academic trials under current regulations can be immensely helpful. These actions aim to streamline the approval process and promote uniformity in ethical review practices across trials.
A major challenge is reluctance among participants for safety procedures or hesitancy to participate in randomized trials. This can be combated through evidence-based media reporting and educational programs aimed at debunking myths.
Funding uncertainties and legal concerns affected by evolving regulatory advisories can be a major hurdle for clinical trials. Advocacy for consistent policy guidance and support from funding agencies to maintain trial integrity and ensure continuity is needed to tackle this.

Conclusion

Drug clinical trials in India are essential to validate the safety and efficacy of new treatments. With its diverse population and cost-effective research environment, India is emerging as a key player in drug clinical trial services.

Addressing challenges effectively will boost India’s stature in this field, contributing to global advancements in healthcare. By leveraging its strengths and enhancing regulatory frameworks, India can continue to attract and conduct impactful clinical trials that benefit patients worldwide.

References

Clinical Trials. [Internet] World Health Organization [cited 2024 June 28]. Available from: https://www.who.int/health-topics/clinical-trials#tab=tab_1
FAQ Clinical Trials. [Internet] Central Drugs Standard Control Organization [cited 2024 June 28]. Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/GCT_PDFs/FAQ_CT.pdf
Poongothai S, Unnikrishnan R, Balasubramanian J, Nair MD, Mohan V. Why are clinical trials necessary in India? Perspect Clin Res. 2014 Apr;5(2):55-9. doi: 10.4103/2229-3485.128018. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3980544/
Bassi A, Arfin S, Joshi R, Bathla N, Hammond NE, Rajbhandari D, Tirupakuzhi Vijayaraghavan BK, Venkatesh B, Jha V. Challenges in operationalising clinical trials in India during the COVID-19 pandemic. Lancet Glob Health. 2022 Mar;10(3):e317-e319. doi: 10.1016/S2214-109X(21)00546-5. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8694703/

India’s Food Sufficiency: Current Status & Impact of consumer claims for better new food trends acceptability

Fri, 19 Jul 2024 12:40:39 GMT

India’s Food Sufficiency: Current Status & Impact of consumer claims for better new food trends acceptability

Summary

India’s food sufficiency rate is influenced by agricultural production, distribution, and consumer awareness.
It impacts the consumer acceptance to new food trends
Efficacy evaluation of food in India is crucial to ensure nutritional adequacy and safety.
Educating consumers about nutrition and food choices is essential to improve food sufficiency.
Continued focus on these areas can help India enhance its food sufficiency rate and overall nutritional status.

Introduction

This article explores India’s food sufficiency rate, highlighting the impact of agricultural productivity, distribution, and consumer awareness. It discusses key government schemes to enhance food security and address malnutrition and emphasizes the importance of consumer education and regulatory oversight in maintaining food quality and safety.

Understanding Food Sufficiency

Food self-sufficiency means a country produces enough food to meet its own needs but may still trade food. A practical view is to produce food equal to or more than what is consumed. Further, food self-sufficiency and food security are intertwined but different.

A country can be self-sufficient yet face hunger due to poor food distribution, while other countries may rely on imports and still be food secure.

As we explore food self-sufficiency, going ahead in this article we’ll examine how advances in food production, technology and consumer claims among other aspects are related and their role in shaping consumer perceptions and influencing the food industry’s approach to self-sufficiency in the country.

Food Sufficiency Scenario in India

In India, food sufficiency is closely tied to agricultural productivity, distribution systems, and consumer access to nutritious food options. Agriculture is the foundation of India’s economy, especially for over 70% of rural households.

Since 1950-51, food grain production has surged from 50 million tonnes to nearly 300 million tonnes in 2019-20, making a six-fold increase. This growth has played a crucial role in making India a net food exporter and the ninth-largest exporter of agricultural products worldwide.

With these milestones, India has gone from a food-deficit nation to being self-sufficient in food grains in the past 30 years. This progress is largely due to the 2013 National Food Security Act (NFSA), which provides subsidized monthly rations of rice, wheat, or millets to 813 million people through the Public Distribution System.

Despite achieving grain self-sufficiency, challenges persist, including heavy reliance on imports for edible oils and pulses, with around 55–60% of edible oil consumption and one-third of pulses imported. Challenges being faced to meet such needs include resource-intensive agriculture, regional biases, and sustainability issues such as water stress and land degradation.

Consumer Claims and Food Sufficiency

Consumer claims (Nutritional claims on labels) regarding food availability, quality, and safety are closely tied to India’s food sufficiency rate.

A higher food sufficiency rate assures consumers of consistent food availability, which is crucial for their sense of food security. In recent years, consumer concerns in India have expanded to include nutritional value and food safety, reflecting a growing awareness about food.

Efficacy evaluation of food in India is essential to address these consumer concerns. To guarantee the nutritional quality and safety of food, demanding quality control measures and firm adherence to food safety standards are essential.

Regulatory bodies like the Food Safety and Standards Authority of India (FSSAI) play a crucial role in overseeing and regulating food quality, responding to consumer concerns, and protecting public health.

Product-led Claims in India’s Food Market

Product-led claims have also become prominent in India’s food market due to increasing health awareness and nutritional consciousness among consumers.

There is a growing demand for food products that provide specific health benefits, increasing product-led claims where companies emphasize the nutritional content and health advantages of their products.

However, these claims must be substantiated with scientific evidence and comply with regulatory standards set by authorities like FSSAI. Clear and accurate labelling is essential to empower consumers to make informed choices and to build trust in the food supply chain.

Additionally, educating consumers about nutrition, food choices, and the importance of a balanced diet is crucial for improving India’s food sufficiency rate. This includes:

Fig 1: Product-led Claims in India’s Food Market

Enhancing Food Sufficiency: Key Government Schemes in India

India has implemented a range of impactful government schemes aimed at enhancing food sufficiency and addressing malnutrition across the country. These initiatives target various aspects of nutrition, food accessibility, and economic empowerment for vulnerable populations.

These schemes aim to improve food security by ensuring subsidized food distribution, promoting nutritional awareness, enhancing maternal and child health, and providing employment opportunities, thereby contributing to the eradication of food sufficiency problems in India as mentioned in Table 1.

Scheme	Objective	Beneficiaries
National Food Security Act (NFSA)	Ensure subsidized food grains distribution through PDS	813 million people
Mid-Day Meal Scheme (MDMS)	Provide nutritious meals to school children	Children in government-aided schools
Pradhan Mantri Matru Vandana Yojana (PMMVY)	Provide financial assistance to pregnant and lactating women	Pregnant and lactating women
Targeted Public Distribution System (TPDS)	Subsidize food grains for people below the poverty line	81 crore people (as per NFSA mandate)
POSHAN Abhiyaan	Reduce undernutrition through breastfeeding promotion, dietary diversification, and anaemia control	Pregnant women, lactating mothers, children
Mahatma Gandhi National Rural Employment Guarantee Act (MNREGA)	Provide guaranteed wage employment to rural households	Rural households

Conclusion

India’s journey toward achieving a high food sufficiency rate has been marked by significant progress in agricultural productivity, despite ongoing challenges. Heeding to consumer claims while strengthening has become increasingly important in shaping agricultural policies and market trends. Strengthening the efficacy evaluation of food has also become crucial for maintaining consumer trust and promoting public health. Lastly ensuring transparency in product-led claims is another vital aspect of India‘s food sufficiency efforts. Clear and honest labeling helps consumers make informed choices and supports the integrity of the food supply chain. Addressing these aspects, India can continue to enhance its food sufficiency rate, ensuring that its population has access to safe, nutritious, and affordable food.

References

Jennifer Clapp, Food self-sufficiency: Making sense of it, and when it makes sense, Food Policy, Volume 66,2017, Pages 88-96, ISSN 0306-9192. Available from: https://www.sciencedirect.com/science/article/pii/S0306919216305851
Swaminathan MS, Bhavani RV. Food production & availability–essential prerequisites for sustainable food security. Indian J Med Res. 2013 Sep;138(3):383-91. PMID: 24135188; PMCID: PMC3818607. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3818607/
Nutrition and Food security. [Internet] Food and Agriculture Organization [cited 2024 June 28]. Available from: https://india.un.org/en/171969-nutrition-and-food-security
India at a glance. [Internet] Food and Agriculture Organization [cited 2024 June 28]. Available from: https://www.fao.org/india/fao-in-india/india-at-a-glance/en/
Self-sufficiency in Edible Oil Production [Internet] National Academy of Agricultural Sciences [cited 2024 June 28]. Available from: https://naas.org.in/Policy%20Papers/policy%20121.pdf
Sustaining the Pulses Revolution in India: Technological and Policy Measures [Internet] National Academy of Agricultural Sciences [cited 2024 June 28]. Available from: https://naas.org.in/Policy%20Papers/policy%20116.pdf
Food security. [Internet] Food and Agriculture Organization [cited 2024 June 28]. Available from: https://www.fao.org/4/Y5061E/y5061e08.htm
Food Safety and Standards Authority of India (FSSAI) [Internet] FSSAI [cited 2024 June 28]. Available from: https://fssai.gov.in/cms/about-fssai.php
Hutchinson J, Watt JF, Strachan EK, Cade JE. Evaluation of the effectiveness of the Ministry of Food cooking programme on self-reported food consumption and confidence with cooking. Public Health Nutr. 2016 Dec;19(18):3417-3427. doi: 10.1017/S1368980016001476. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10270814/
Pavleen Soni, Kiranjot Kaur, Examining claims on food packages in India: Are they inadequate and deceptive? Measurement: Food, Volume 11, 2023, 100100, ISSN 2772-2759. Available from: https://doi.org/10.1016/j.meafoo.2023.100100
Hassoun, Abdo & Cropotova, Janna & Trif, Monica & Rusu, Alexandru & Bobis, Otilia & Nayik, Gulzar & Jagdale, Yash & Saeed, Farhan & Afzaal, Muhammad & Mostashari, Parisa & Khaneghah, Amin & Regenstein, Joe. (2022). Consumer acceptance of new food trends resulting from the fourth industrial revolution technologies: A narrative review of literature and future perspectives. Frontiers in Nutrition. 9. 10.3389/fnut.2022.972154. Available from: https://www.researchgate.net/publication/362015560_Consumer_acceptance_of_new_food_trends_resulting_from_the_fourth_industrial_revolution_technologies_A_narrative_review_of_literature_and_future_perspectives
Silva P, Araújo R, Lopes F, Ray S. Nutrition and Food Literacy: Framing the Challenges to Health Communication. Nutrients. 2023 Nov 7;15(22):4708. doi: 10.3390/nu15224708. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10674981/
Science Leading India towards Self-sufficiency in Food [Internet] Department of Science and Technology [cited 2024 June 28]. Available from: https://www.indiascienceandtechnology.gov.in/featured-science/science-leading-india-towards-self-sufficiency-food

Ensuring Success in Clinical Performance Evaluation for IVDs: Strategies for Sponsors

Thu, 23 May 2024 10:28:46 GMT

Ensuring Success in Clinical Performance Evaluation for IVDs: Strategies for Sponsors

Summary

In healthcare, in vitro diagnostics (IVDs) play a vital role in diagnosing diseases and monitoring treatment effectiveness.
However, before these crucial diagnostics can reach patients and healthcare providers, they must undergo clinical performance evaluation to ensure their safety and efficacy.
The regulatory process is complex, and sponsors face many challenges to ensure their products meet regulatory standards for evaluation.
To succeed in this process, sponsors must focus on regulatory compliance, designing comprehensive studies, ensuring data quality, adhering to ethical standards, and collaborating with stakeholders.

Introduction

In vitro diagnostics (IVDs) are important tools used in the diagnosis and monitoring of treatments. These devices conduct tests outside the body, using specimens like blood, tissue, or urine to provide valuable health information. Examples include test strips and reagents for diagnosis, prognosis, treatment, and monitoring of various conditions. Clinical performance evaluation (CPE) is important for sponsors of IVDs to ensure their accuracy, reliability, and safety before they reach patients and healthcare providers.

Sponsors of medical devices play a significant role in ensuring that IVDs meet regulatory standards for accuracy, reliability, and safety before they are made available to patients and healthcare providers. As a sponsor, your role goes beyond meeting industry standards; it involves overcoming the challenges of the evaluation process and navigating the complexities of the regulatory guidelines. Success of CPE demands focusing on regulatory compliance, designing comprehensive studies, ensuring data quality, adhering to ethical standards, and collaborating with stakeholders.

Strategies for Success in Clinical Performance Evaluation For IVDS

Clinical performance evaluation (CPE) is necessary for IVDs to ensure their accuracy, reliability, and safety. CPE assesses an IVD’s ability to provide results that correlate with specific clinical conditions or physiological states, verifying performance claims by the manufacturer. This evaluation is crucial for regulatory approval, compliance with standards, and ensuring that healthcare professionals can trust the test results.

In India, the Central Drugs Standard Control Organization (CDSCO) regulates IVDs to ensure their safety, efficacy, and quality. Compliance with CDSCO regulations is crucial for sponsors throughout the CPE process. However, navigating the complex and challenging CDSCO requirements can be daunting for sponsors.

To ensure success of the evaluation of IVDs, sponsors can adopt the following strategies:

Fig 1: Strategies for Success in Clinical Performance Evaluation For IVDS

Regulatory Compliances

Strict adherence to CDSCO guidelines throughout the CPE process is crucial. Sponsors must understand the specific requirements for registration, licensing, and post-market surveillance of IVDs. Form MD-24 must be filled for permission to conduct clinical performance evaluation. It is essential to be aware of and adhere to the associated fees for these forms. Following the step-by-step CDSCO process and guidelines is essential for success and regulatory compliance.

Developing a Comprehensive Performance Evaluation Plan (PEP)

Creating a detailed Performance Evaluation Plan (PEP) is a crucial strategy for ensuring success in the CPE. A well-thought-out PEP serves as a roadmap for the evaluation process, ensuring that all necessary aspects are covered. The PEP should include a comprehensive device description, study design, and statistical methods for data analysis. It should also address potential risks and mitigation strategies, ensuring that the evaluation is conducted safely and effectively. By developing a comprehensive PEP, sponsors can demonstrate the safety and efficacy of their IVDs, meeting regulatory requirements and ensuring the trust of healthcare professionals in the test results.

Compliance with Ethical Standards

Ensuring that the evaluation is conducted ethically is critical. This includes obtaining approval from an Ethics Committee registered with the CDSCO and ensuring that the study is conducted in accordance with ethical guidelines, such as the Declaration of Helsinki and Indian Council of Medical Research (ICMR) guidelines. Adhering to these standards demonstrates the sponsor’s commitment to participant safety and rights, contributing to the overall success and credibility of the evaluation process.

Conducting Robust Analytical and Clinical Studies

Data collection and analysis are critical aspects of the clinical performance evaluation process. Sponsors should ensure high-quality data collection using validated methods and instruments. Additionally, they should conduct thorough analytical and clinical studies to evaluate the performance characteristics of the IVD accurately. This includes conducting robust statistical analyses and interpreting the results in the context of the device’s intended use and clinical significance. By conducting comprehensive studies, sponsors can generate meaningful results that support the safety and effectiveness of the IVD.

Stakeholder Engagement

Stakeholder engagement involves actively involving healthcare professionals, patients, regulatory authorities, and industry experts throughout the CPE process. This includes seeking their input on study design, endpoints, and methodologies to ensure that the evaluation meets their needs and expectations. Engaging stakeholders can also help in obtaining support for the evaluation, addressing any concerns or challenges that may arise, and ultimately ensuring that the study is conducted effectively and produces meaningful results.

Transparency and Adherence to Standards

Ensuring transparency and adherence to regulatory requirements, includes accurate documentation, timely fee submission, and openness to inspections. Continuous monitoring of the evaluation process ensures compliance with the approved plan and guidelines, contributing to the overall success of the performance evaluation.

Conclusion

In conclusion, successfully navigating a CPE process for IVDs in India requires strategic planning and strict adherence to regulatory standards. Sponsors must develop detailed performance evaluation plans, follow ethical guidelines, conduct thorough analytical and clinical studies, and engage with stakeholders. Transparency, regulatory compliance, and continuous monitoring are essential. These strategies help sponsors navigate CDSCO regulations, ensuring the success and credibility of their IVDs in the Indian market, ultimately benefiting patients, healthcare providers, and the healthcare system.

References

Central Drugs Standard Control Organization. (2017). Medical Devices Rules, 2017. Retrieved from https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules,%202017.pdf
CDSCO. (2022). CDSCO-IVD-FAQ-03-2022. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/IVD/FAQs/CDSCO-IVD-FAQ-03-2022-.pdf
Indian Council of Medical Research. (2017). Ethical guidelines for biomedical research on human participants. Retrieved from
Available from: https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf
Central Drugs Standard Control Organization (CDSCO). (2018). Draft Guidance on Performance Evaluation Report (PER). Retrieved from https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/1Draft%20Guidance%20on%20PER%20.pdf

Maximizing Efficiency in Clinical Trials: Leveraging the Expertise of CROs in India

Thu, 23 May 2024 10:28:45 GMT

Maximizing Efficiency in Clinical Trials: Leveraging the Expertise of CROs in India

Summary

As clinical trials are increasing in demand and complexity, more time, capital and efforts go into its management and successful completion.
Indian contract research organizations (CRO) have seen a remarkable rise in demand due to low-cost structure, updated regulatory standards, and timely completion of the clinical trial process.
Many pharmaceutical and medical device companies in other countries partner with the expertise of CROs in India due to fairly huge and diverse patient load, highly skilled and motivated healthcare professionals, well-equipped hospitals, and strong technological support.

Introduction

Indian Contract Research Organizations (CROs) contribute significantly to the efficiency of clinical trials. The benefits of partnering with Indian CROs include cost-effectiveness and access to diverse patient populations, and more. Additionally, we discuss the challenges faced by CROs in India, like data privacy and patient retention, along with potential solutions.

What is a CRO?

A contract research organization (CRO) is a company that provides research services to pharmaceutical, biotechnological, and medical device industries. The companies or sponsors outsource a part or whole of their research needs on a contractual basis.

The major role of the CRO is to manage various aspects of the clinical trials and adhere to specific objectives, good clinical practice (GCP), and protocol design involved in its development.

Fig 1: CRO Services in India

How is partnering with a CRO in India beneficial for clinical trials?

Needless to say, having a CRO to conduct your clinical trials can be beneficial in numerous ways, as follows:

1. Cost and time effective

Clinical trial is a complex and time-consuming process. Working with a CRO offers great potential to cut down the cost

In India, the cost of conducting clinical trials is nearly 50% less compared to other countries.
Most CROs are well established and possess a state-of-the-art infrastructure and resources necessary for conducting clinical trials effectively within the stipulated time.
CROs eliminate the need for the pharma and biotech companies to invest in in-house resources.

2. Diverse patient recruitment and retention

For the success of a clinical trial, the inclusion of a diverse population is crucial as it represents the study of a wide range of populations.

CROs help in targeting and recruiting diverse patients ensuring equitable study participation.
India has an added benefit because of its patient pools across communities.
Retention of patients throughout the clinical trial helps to cut down the cost of recruiting new patients as well as provide more accurate and ‘real-world’ evidence.

3. Skill and expertise

Outsourcing to CRO has one significant benefit gaining of access to a highly skilled team of professionals.
They have sound scientific knowledge and experience in various fields of clinical research which aids in a successful outcome of the trial process.
CROs are well-versed with the objectives, protocol, and regulatory guidelines which helps in ensuring a clinical trial that is well-structured and compliant.

4. Wide array of services

CROs in India provide a wide range of services such as data analysis and management, regulatory compliance, pharmacovigilance, medical writing, and clinical research management.
CRO helps to streamline clinical trial management by providing all the research services under one roof.
They can also provide a statistical analysis evaluating the safety and efficacy of the drug being studied.

5. Cutback on overall risk

Any clinical trial has its own set of possible risks such as regulatory issues and concerns around patient safety.
CROs have an in-depth understanding of the associated risks of conducting clinical trials.
They know how to navigate along the unexpected risks that may arise such as non-compliance to the drug and manage them effectively.
CROs are also well aware of the ever-changing dynamics of clinical research and can also guide manufacturing companies on risk mitigation strategies to facilitate a successful clinical trial outcome.

Challenges and their solutions for CROs in India

Despite India’s advancement in the field of global clinical research landscape, it faces certain challenges that require attention.

a. Data privacy and management

Compared to developed countries, ensuring the privacy of massive volumes of data generated during clinical trials and managing them is very challenging.
One fairly good method is to utilize artificial intelligence (AI) and automated data analysis to enhance data quality and management.

b. Patient retention

One major issue is the retention of recruited patients on a long-term basis throughout the study.
Engaging the community more and leveraging new-age technology will help to increase the chances of successful trial completion.

c. Regulatory hurdles

Strict compliance standards and constantly changing regulatory guidelines are roadblocks to clinical trial approval and completion.
Biotech and pharmaceutical companies need to come up with more innovative strategies to navigate through such challenges.

d. Limited resources

Small to medium CROs, biotech startups usually face resource constraints which put them behind the competition from larger CROs.
One solution will be exploring alternative access for funding and maximal usage of digital technologies.

e. Partnerships and communication

Collaboration with multiple organizations, institutions, and partners can lead to miscommunication and interpretations which affects the optimal functioning of the trial process.
It is vital to maintain transparency in communication and build mutual trust to establish a strong partnership.

Fig 2: Challenges and their solutions for CROs in India

An overview of the role of CRO in clinical trials

Benefits

Challenges

Strategies

1. Increase trial participation from a diverse population pool

2. Maintain data quality and accuracy

3. Cost-effective

4. Leverage expertise and technology in regulatory requirements

1. Retaining the recruited patients.

2. Miscommunication and lack of coordination between companies and CROs.

3. Regulatory compliance, delay in approval.

4. Data Privacy

1. Implementation of the latest technologies for data analysis and management.

2. Maintain transparency in partnerships.

3. Conduct training sessions for CRO staff.

4. Regulatory guidelines must align with international standards.

Table 1: CRO: benefits, challenges, and strategies to leverage efficacy of clinical trials

Conclusion

The role of CROs in the successful outcome of clinical trials is of paramount importance. Despite the highly ranked and competitive global CROs around the world, Indian CROs are always at the top list of preferences of global pharmaceutical and biotechnological companies.

Despite plenty of CROs in India, how can you make sure to find the ideal one? Well, there is no need to look back as here is the best team to assist you. CliniExperts with its reliable and skillful team offers a well-organized, meticulous, and amicable approach to managing all regulatory requirements.

CliniExperts offers a hassle-free experience by providing all the services under one roof.

References

Central Drugs Standard Control Organization. (2017). Medical Devices Rules, 2017. Retrieved from https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules,%202017.pdf
CDSCO. (2022). CDSCO-IVD-FAQ-03-2022. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/IVD/FAQs/CDSCO-IVD-FAQ-03-2022-.pdf
Indian Council of Medical Research. (2017). Ethical guidelines for biomedical research on human participants. Retrieved from
Available from: https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf
Central Drugs Standard Control Organization (CDSCO). (2018). Draft Guidance on Performance Evaluation Report (PER). Retrieved from https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/1Draft%20Guidance%20on%20PER%20.pdf

Understanding the Importance of Clinical Performance Evaluation for IVDS: Meeting Regulatory Expectations

Thu, 23 May 2024 10:28:43 GMT

Understanding the Importance of Clinical Performance Evaluation for IVDS: Meeting Regulatory Expectations

Summary

In vitro diagnostics (IVD) are tests that are carried out outside the human body to diagnose a wide range of illnesses and monitor various medical conditions.
Importance of Clinical Performance Evaluation (CPE) for IVDS is essential for ensuring the accuracy and reliability of these diagnostic tools.
Meeting regulatory expectations is crucial for ensuring the safety, efficacy, and quality of these devices.
Adopting strategies like thorough research, building strong partnerships, investing in quality management systems, and staying informed about regulatory developments can navigate the regulatory process effectively and bring compliant IVD devices to the market, ultimately benefiting patients and healthcare providers alike.

Introduction

Having a detailed clinical performance evaluation for in-vitro diagnostics in India is extremely important to meet the regulatory expectations. It highlights the need for thorough research, strong partnerships, and compliance with quality management systems to navigate the regulatory process effectively.

What are In-Vitro Diagnostics?

In vitro diagnostics (IVD) are tests that are carried out outside the body to diagnose a wide range of illnesses and monitor various medical conditions. These tests involve using specialized tools and instruments such as test strips and reagents to analyse specimens like blood, tissue, or urine.

Types of IVDs

In India, the Central Drugs Standard Control Organization (CDSCO) classifies IVDs into four categories based on the potential risks associated with their use.

Risk Class	Description	Example
Class A	Low-risk	Blood smear cassette
Class B	Low to moderate risk, requires registration	Pregnancy test kits, blood glucose test strips
Class C	Moderate to high risk, requires registration	HIV test kits, Hepatitis B test kits
Class D	High risk, requires approval	Cancer diagnostic kits, genetic test kits

Table 1: Classification of IVD Medical Devices

Why Clinical Performance Evaluation is important?

Clinical Performance Evaluation (CPE) helps to assess the analytical and clinical performance of a new IVD medical device. It tests for its sensitivity, specificity, safety, accuracy, precision, and clinical validity, using human specimens systematically. It is an ongoing process that continues throughout the device’s lifecycle. Thorough clinical performance evaluations help to demonstrate the effectiveness and reliability of IVD devices, ensuring compliance with regulatory standards and suitability for diagnosing and monitoring medical conditions.

Process of Clinical Performance Evaluation

The Central Drugs Standard Control Organization (CDSCO) in India regulates the process of CPE to ensure that IVDs meet the necessary standards for accuracy, safety, and clinical validity. It includes the following steps:

Conduct of clinical investigation: It must be conducted in accordance with CDSCO rules and the permission has to be granted by the Central Licensing Authority.
Ethical Approval: Before conducting the study, approval must be obtained from an Ethics Committee registered with CDSCO. The committee ensures that the study meets ethical standards and safeguards the rights and welfare of participants.
Application for Permission: The sponsor must submit an application for permission to conduct a clinical investigation to the Central Licensing Authority in Form MD-22, accompanied by specified information.
Pilot Clinical Investigation: If conducting a pilot clinical investigation, the sponsor must pay a fee as specified in the Second Schedule and provide information as specified in the Seventh Schedule.
Grant of Permission: The Central Licensing Authority may grant permission to conduct a clinical investigation if satisfied that the requirements have been complied with. If not satisfied, the application may be rejected within ninety days.
Conditions for Permission: After grant of permission, the sponsor must comply with several conditions, including initiating the investigation after Ethics Committee approval, conducting the investigation according to approved plans and guidelines, and registering the investigation with the Clinical Trial Registry of India.
Reporting and Documentation: The sponsor must submit annual status reports of each investigation to the Central Licensing Authority and report any suspected unexpected serious adverse events within fourteen days.
Medical Management and Compensation: In case of injury or death during a clinical investigation, the sponsor must provide complete medical management or compensation as per the rules.
Inspection and Review: The premises of the sponsor and clinical investigation sites are open for inspection by the Central Licensing Authority to verify compliance with the rules. The Authority may impose or exempt any condition while granting permission for specific investigations.

Therefore, evaluation of IVDs is a systematic and rigorous process that ensures these devices meet the necessary standards for accuracy, safety, and clinical validity, as per the guidelines set by CDSCO.

Fig 1: Process of Clinical Performance Evaluation

Regulation of IVDs

The regulatory assessment of an IVD device involves several key steps to ensure compliance with regulatory requirements and standards.

Fig 2: Regulatory Assessment of IVDS

In India, the regulation of IVD devices is governed by the CDSCO under the Medical Devices Rules, 2017. These rules establish the regulatory framework for the registration, import, manufacture, sale, and distribution of IVD devices in the country. Meeting regulatory expectations in the context of IVD devices poses several challenges, but with the right strategies, these challenges can be overcome.

One of the key challenges in meeting regulatory expectations is ensuring compliance with the stringent requirements set forth by the CDSCO. This includes the need for CPE studies to demonstrate the analytical and clinical performance of IVD devices.

Challenges in Meeting Regulatory Expectations

Some of the common challenges faced by manufacturers in meeting regulatory expectations are:

Lack of clarity: The regulatory requirements for IVD devices can be complex and ambiguous, leading to confusion among manufacturers.
Resource constraints: Conducting CPE studies and obtaining regulatory approvals require significant resources in terms of time, money, and expertise.
Changing regulations: The regulatory landscape for IVD devices is constantly evolving, requiring manufacturers to stay updated with the latest requirements.

Strategies for Successful Evaluation

To overcome these challenges and meet regulatory expectations, manufacturers can adopt the following strategies:

Conduct thorough research: Understand the regulatory requirements specific to IVD devices in India and seek guidance from experts if needed.
Build strong partnerships: Collaborate with local experts, consultants, and regulatory bodies to navigate the regulatory process effectively.
Invest in quality management systems: Implement robust quality management systems to ensure compliance with regulatory requirements and standards.
Stay informed: Keep abreast of the latest developments in the regulatory landscape for IVD devices in India and adapt your strategies accordingly.

Conclusion

In conclusion, meeting regulatory expectations for a CPE for In-Vitro Diagnostics in India is crucial for ensuring the safety, efficacy, and quality of these devices. While the regulatory landscape may pose challenges such as complex requirements and resource constraints, manufacturers can overcome these challenges by adopting strategies like thorough research, building strong partnerships, investing in quality management systems, and staying informed about regulatory developments. By doing so, manufacturers can navigate the regulatory process effectively and bring compliant IVD devices to the market, ultimately benefiting patients and healthcare providers alike.

References

Regulatory guidance for medical device 2017 CDSCO https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4NQ==
GHTF (2008b) Principles of In-Vitro Diagnostic (IVD) Medical Devices Classification 2016. https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n8-2012-clinical-performance-studies-ivd-medical-devices-121102.pdf#:~:text=The%20objective%20of%20a%20clinical%20performance%20study%20is,literature%20and%2For%20experience%20gained%20by%20routine%20diagnostic%20testing. A GUIDANCE DOCUMENT for MEDICAL DEVICES Indian Pharmacopoeia Commission National Coordination Centre-Materiovigilance Programme of India Ministry of Health & Family Welfare Government of India https://ipc.gov.in/images/mvpi/Guidance_Document.pdf
Overview on Performance Evaluation / External Evaluation of In-vitro Diagnostic Medical Device (IVDMD) 2022 Ministry of Health and Family Welfare Government of India https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/1Draft%20Guidance%20on%20PER%20.pdf
Manu M, Anand G. A review of medical device regulations in India, comparison with European Union and way-ahead. Perspect Clin Res. 2022 Jan-Mar;13(1):3-11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8815674/

The Role of Clinical Research Services in India in Meeting Regulatory Expectations

Mon, 06 May 2024 14:19:22 GMT

The Role of Clinical Research Services in India in Meeting Regulatory Expectations

Introduction

In the field of clinical research, where novel findings and transformative medical breakthroughs emerge, regulatory compliance is a crucial cornerstone. In regulatory expectations meeting clinical research provides global Clinical trial approval, safety reporting, test license services, etc. Clinical research organizations in India have become leaders in maintaining adherence to complex regulatory frameworks among the several centers of excellence for research.

Why are clinical trials necessary in India?

As a vital part of India’s commitment to drug discovery and development, clinical studies are becoming a more significant activity in the country. Clinical trials provide numerous advantages to participants in addition to furthering knowledge.

Conducting carefully planned clinical trials is the only reliable method of assessing a novel medication. This emphasizes the necessity of making sure that regulatory standards are followed and that relevant staff members are properly trained in good clinical practice (GCP). This would guarantee that clinical trials continue to benefit India and position the country as a global leader in this area.

Understanding the roles of the regulatory bodies

The key documents in clinical research include the Drugs and Cosmetics Act (1940) and Drugs and Cosmetics Rules (1945), the Indian Council of Medical Research (ICMR), 2017 (National Ethical Guidelines for Biomedical and Health Research involving human participants), and Indian Good Clinical Practice Guideline (2001).

A complicated network of laws, regulations, and guidelines governs the field of clinical research. It is both an ethical obligation and a need for the validity and acceptability of research findings to ensure adherence to these principles.² The basic regulations in India and the main documents followed include:

Regulations in India	Key Documents Followed
Law	Drugs and Cosmetics Act (1940) and Drugs and Cosmetics Rules (1945)
Regulations	The New Drugs and Clinical Trial Rules, 2019⁵
Guidelines	Indian Council of Medical Research (ICMR) guidelines Good Clinical Practice (GCP) guidelines, 2017

The roles and responsibilities of the regulatory bodies include:

Clinical studies (trials) for both newly approved indications of registered medications and non-registered medications must be reviewed by regulatory bodies.
It is legally required of regulatory authorities to make sure that the medications that are sold in the nation meet the standards for efficacy, quality, and safety.
In the event of significant violations of good clinical practice, it is the duty of regulatory authorities to terminate an ongoing trial.
It is the duty of regulatory authorities to put in place a system of regulations requiring registration from all clinical trials planned to be carried out in the nation.
The regulatory authorities shall bear the primary responsibility of promoting, guaranteeing, and overseeing adherence by authorized ethical committees in a nation that has pertinent laws, rules, and directives, including guidelines.

Sponsors and CROs

A sponsor is an individual, business, institution, or other group that assumes accountability for the planning, execution, and/or funding of clinical studies or trials.

An organization hired by a different business or research facility to manage particular facets of a clinical study is known as a clinical research organization or contract research organization. The company may organize, supervise, and design the trial in addition to assessing the results.

How do Clinical Research Organizations in India meet Regulatory Expectations

A CRO in India is a blessing for both pharmaceutical and research needs, as they can multitask within a set timetable.

The services provided by CRO include:

Clinical Research Services Provided	Meeting Regulatory Expectations
Global Clinical Trials Approval (GCT)	Helps to complete the application for a GCT approval which includes Form CT-04 (Application for grant of permission to conduct clinical trial of new drug or investigational new drug), Form CT-10 (Application for grant of permission to manufacture new drug or investigational new drug to conduct clinical trial), Form CT-12 (Application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for clinical trial), Form CT-13 (Application for grant of permission to manufacture of unapproved active pharmaceutical ingredient for development of formulation for clinical trial), and/or Form CT-16 (Application for grant of license to import new drug or investigational new drug for clinical trial).
Safety reporting	As per the New Drugs and Clinical Trial Rules, 2019, , periodic safety update reports (PSURs), are submitted once every six months for the first two years and annually for the subsequent two years.
Test license	By the 2019 new drug and clinical trial regulations, CDSCO accepts applications in Form CT-11/CT-14/CT-15/CT-17 for the granting of a license for the manufacturing or import of new pharmaceuticals for testing, analysis, or clinical trial study. Form CT-11: After reviewing the documents submitted with the application in Form CT-10 and conducting any additional investigations as deemed necessary, the Central Licensing Authority may permit the manufacture of the new drug or investigational new drug for use in clinical trials, bioavailability or bioequivalence studies, or for the purpose of examination, testing, and analysis of the new drug or investigational new drug.
Clinical Trial Registry India (CTRI) Registration	Ensures trial registration in the CTRI. Provides a registration number for every trial in each publication. Provides details of the target sample size, trial locations, enrollment date, and investigator details. Following registration, they update the trial status on a regular basis with any modifications.
Ethics Committee Registration	Ensures submission of ethics committee registration application as per rule 8. Assists in submitting Form CT-01 (application for grant of registration to the central licensing authority). Registration is granted via Form CT-02.

Fig 1: Services provided by CROs

Conclusion

Cliniexperts is a full-service provider of clinical trial solutions with over a decade of experience in the market. The team’s expertise and wide industry networks make it easy to procure the licenses and approvals your products need. Cliniexperts is a one-stop shop for clinical research services in India, capable of handling a variety of regulatory issues, ensuring complete client satisfaction.

Performing clinical trials not only advances science but also offers numerous advantages to the individuals involved. With sufficient regulations in place to guarantee participant safety, clinical trials have made India a major global center. India will continue to gain from clinical trials as long as regulatory standards are followed and relevant personnel are properly trained in GCP.

References

Poongothai S, Unnikrishnan R, Balasubramanian J, Nair MD, Mohan V. Why are clinical trials necessary in India? Perspectives in Clinical Research [Internet]. 2014;5(2):55–9.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3980544/
Gogtay NJ, Ravi R, Thatte UM. Regulatory requirements for clinical trials in India: What academicians need to know. Indian Journal of Anaesthesia [Internet]. 2017 Mar 1;61(3):192–9. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5372399/
INDIAN COUNCIL OF MEDICAL RESEARCH 2017 NATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL AND HEALTH RESEARCH INVOLVING HUMAN PARTICIPANTS [Internet].
Available from: https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf
K. Kamnoore, M P Venkatesh, Balamuralidhara V, T M Pramod Kumar. Regulatory requirements for conducting Clinical Trials in India. Research J. Pharm. and Tech 2020; 13(3):1517-1522.
Available from: https://rjptonline.org/HTMLPaper.aspx?Journal=Research%20Journal%20of%20Pharmacy%20and%20Technology;PID=2020-13-3-81
The New Drugs and Clinical Trials Rules, 2019 [Internet]. Cdsco.gov.in. 2023.
Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTIzMA==
Roles and Responsibilities of the Regulatory authority CHAPTER-II [Internet].
Available from: https://webstor.srmist.edu.in/web_assets/srm_mainsite/files/downloads/Responsibilities_of_Regulatory_authority.pdf
Clinical study sponsor [Internet]. Toolkit.
Available from: https://toolkit.ncats.nih.gov/glossary/clinical-study-sponsor/
Definition – Contract Research Organization [Internet]. National Cancer Institute. 2011.
Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/contract-research-organization
CRO Support, Clinical Trials, Research & Approval -CliniExperts [Internet]. cliniexperts.com. Available from: https://cliniexperts.com/india-regulatory-services/cro/
Application For Global Clinical Trial [Internet].
Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/GCT_PDFs/GCT_Checklist.pdf
Notice [Internet]. Cdsco.gov.in. 2024
Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTYyMQ==

Navigating the Regulatory Landscape: How CROs in India Ensure Compliance in Clinical Studies

Fri, 19 Apr 2024 14:35:49 GMT

Navigating the Regulatory Landscape: How CROs in India Ensure Compliance in Clinical Studies

Introduction

Clinical research organization’s in India have become leaders in guaranteeing adherence to complex regulatory frameworks. By means of their steadfast dedication to maintaining ethical standards and meticulous attention to detail, these organizations are essential in negotiating the intricate regulatory environment and guaranteeing research results that are revolutionary and credible.

What is a CRO?

A contract research organization or clinical research organization in India is a company contracted by another company or research facility to handle specific aspects of managing clinical studies. The business may plan, coordinate, and oversee the trial, as well as evaluate the outcomes.

Fig 1: CROs ensure compliance by adhering to these requirements

Understanding the regulatory requirements for clinical trials in India

The field of clinical research is regulated by a complex web of rules, policies, and procedures. Ensuring adherence to these principles is a requirement for the validity and acceptance of research findings as well as an issue of ethical duty. The Indian Council of Medical Research (ICMR) is the supreme authority for the purpose of formulating, coordinating, and advancing biomedical research. The key documents in clinical research include:

Document	Purpose
Central Drugs Standard Control Organization	To ensure the quality, safety, and efficacy of medications, cosmetics, and medical equipment in order to protect and improve public health.
New Drug Clinical Trial Rule, 2019	All new drugs, investigational new drugs for human use, clinical trials, bioequivalence studies, bioavailability studies, and ethics committees are subject to and governed by the NDCT Rules.
Clinical investigation of medical devices for human subjects – Good clinical practice, ISO 14155:2020 (E), Third edition 2020-07	This document addresses good clinical practice for the design, conduct, recording and reporting of clinical trials conducted in humans to evaluate the clinical performance or effectiveness and safety of medical devices.
Medical Devices Rules, 2017	The Medical Devices Rules, 2017 are a set of new laws that aim to bring the regulatory framework’s quality standardization up to date with global norms.
In-vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good Study Practice, ISO standard 20916:2019 (E), first edition 2019-05	To evaluate the clinical performance and safety of in-vitro diagnostic (IVD) medical devices for regulatory purposes, clinical performance studies are conducted. This document outlines acceptable study practices for their planning, design, conduct, recording, and reporting.
Drugs and Cosmetics Act (1940) and Drugs and Cosmetics Rules ( )	There are twelve appendices, including forms for informed consent, clinical trial protocols, templates for ethics committee (EC) approval, and a major adverse event (SAE) reporting format.
Ethical Guidelines of the Indian Council of Medical Research (2006)	This guideline addresses two main facets of clinical research: basic guidelines that must be adhered to and recommendations for specific study fields.
Indian Good Clinical Practice Guideline (2001)	A good clinical practice (GCP) guideline was released in 2001 by the CDSCO.

Services provided by CROs in India

A CRO is a blessing for both pharmaceutical and research needs, as they can multitask within a set timetable and provide high quality clinical trial solutions.

The services provided by CROs include:

Services provided by CROs	How CROs ensure compliance
Approval of Global Clinical Trials (GCT)	Completes application for a GCT approval which includes informed consent form, trial site details, investigator’s brochure, formulation data, preclinical data involving animal pharmacological and toxicological studies, results and clinical report of phase I, II, III trials, etc. Provides a checklist of protocol development adjustments and modifications, both major and minor Provides a copy of the letter granting authority to conduct clinical trials, the TR 6 challan, and other items included in the import licence checklist. Verifies any site additions, deletions, closures, or changes to the lead investigator.
Safety reporting	Provides periodic safety update reports, or PSURs, once every six months for the first two years after drug approval. For subsequent two years, these reports are submitted annually as per New Drugs and Clinical Trial Rules.⁴
Test license	Ensures compliance with Form 11 which contains information on the application’s contents as well as a list of required attachments.
Clinical Trial Registry India (CTRI) Registration	Trial registration in the CTRI was once a voluntary procedure, but it is now a crucial and required step that must be taken CROs ensure a registration number for every trial is included in publications. The Indian target sample size, trial locations, enrollment date, and Indian investigator details are all included in CTRI. Following registration, they update the trial status on a regular basis with any modifications.
Ethics Committee Registration	CROs ensure DCGI approval for the trial to be registered under rule 8. Helps in the application for grant of registration to the central licensing authority in Form CT-01. Registration granted through form CT-02.

Summary

An organisation that provides professional services by providing support for research is known as a contract research organisation (CRO).
CROs typically serve the pharmaceutical, biotechnology, in-vitro diagnostic devices and medical device industries. Typical CRO services in the medical device industry include regulatory affairs, conducting clinical trial from Phase I to Phase IV, site selection and initiation, recruitment support, clinical monitoring, data management, trial logistics, biostatistics, medical writing, and project management.
CROs help in the development of biological assays and biopharmaceuticals, product commercialization, pre-clinical and clinical research, clinical trial management, and pharmacovigilance.
CROs provide guidance to understand the regulatory framework by providing knowledge ranging from the preliminary design of a study to the ultimate submission of findings.

Conclusion

CliniExperts are pillars of assurance in the complex world of clinical research, where regulatory compliance is the foundation of credibility. By means of their uncompromising dedication to regulatory standards, rigorous attention to detail, and dedication to ethical procedures, this CRO in India with a track record of over a decade has paved the route toward revolutionary research that changes medical paradigms and transforms lives.

Clinical regulatory organisations in India can offer invaluable advice and assistance because they have a great deal of expertise and experience navigating the regulatory procedure. Regulatory specialists can also help with the interpretation of regulations, the creation of regulatory plans, and the preparation of the paperwork required for regulatory filings. They can also assist business owners in staying informed about any updates or modifications to legislation that might have an effect on their goods.

References

Definition – Contract Research Organisation [Internet]. National Cancer Institute. 2011.
Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/contract-research-organization
Gogtay NJ, Ravi R, Thatte UM. Regulatory requirements for clinical trials in India: What academicians need to know. Indian Journal of Anaesthesia [Internet]. 2017 Mar 1;61(3):192–9. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5372399/
SUO MOTTO DISCLOSURE UNDER SECTION 4 OF RTI ACT, 2005 (CDSCO, Seaport, Kochi) 1. Organisation and Function 1.1 Particulars of its organisation, functions and duties [Section 4(1)(b)(i)] [Internet].
Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Cochin.pdf
The New Drugs and Clinical Trials Rules, 2019 [Internet]. Cdsco.gov.in. 2023.
Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTIzMA==
ISO 14155:2020 [Internet]. ISO. 2020.
Available from: https://www.iso.org/standard/71690.html
Medical Device Rules, 2017 [Internet]. CDSCO.
Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules,%202017.pdf
ISO 20916:2019 [Internet]. ISO.
Available from: https://www.iso.org/standard/69455.html
CRO Support, Clinical Trials, Research & Approval -CliniExperts [Internet]. cliniexperts.com. Available from: https://cliniexperts.com/india-regulatory-services/cro/

Choosing the Right Clinical Research Organisation in India: Key Considerations and Benefits

Fri, 19 Apr 2024 14:20:03 GMT

Choosing the Right Clinical Research Organisation in India: Key Considerations and Benefits

Introduction

A Contract Research Organization (CRO) is a company contracted by manufacturers of pharmaceutical, biological or medical devices and in-vitro diagnostic kits to manage clinical research studies and other services to support product development in all phases of a clinical trial.

What is a CRO?

A contract research organisation (CRO) is a company contracted by another company or research facility to handle specific aspects of managing a clinical study. The business may plan, coordinate, and oversee the trial, as well as evaluate the outcomes. Pharmaceuticals can outsource part of their clinical trials to CROs in India.

Fig 1: Responsibilities of CRO

Phases of Clinical Trial

Clinical research organisations in India play a major role in ensuring safe, ethical clinical trials that are essential to developing new, life-changing drugs and medical devices that benefit millions of patients worldwide. The 4 phases of a clinical trial include:

Clinical Trial Phase	Purpose
Phase 1	Tests new drugs in a small group to evaluate the safe dosage range and identify side effects
Phase 2	Tests the treatments safe in Phase 1 in a larger group. Larger group considered to check for any adverse Assess efficacy and further evaluate safety in a larger group.
Phase 3	Tests treatments in larger populations (different regions and ) To confirm the effectiveness, monitor side effects, and compare to existing treatments.
Phase 4	Conducted after a drug is approved by a Regulatory Authority Testing of treatments done in a wide population over a longer Post-market surveillance to monitor long-term effects and use in a wider population.

Table 1: The phases of a clinical trial

Considerations while choosing a clinical research organisation in India

The sponsor’s obligations under its guidelines for good clinical practice include:

Criteria	Responsibility
Quality Control and Quality Assurance	A sponsor may assign a CRO some or all of the sponsor’s trial-related responsibilities, but the sponsor is always ultimately in charge of ensuring the accuracy and integrity of the trial data. Quality assurance and quality control should be implemented by the CRO.
Documentation	Any trial-related responsibility or role that is delegated to or taken on by a CRO needs to be documented in writing. The sponsor is responsible for supervising all trial-related tasks performed on its behalf, including tasks that are subcontracted to a third party by the sponsor’s designated CRO(s).
CRO and Sponsor Capabilities	The sponsor retains all trial-related responsibilities and tasks that aren’t expressly delegated to or taken on by a CRO.
CRO and Sponsor Responsibilities	If a CRO has taken on a sponsor’s trial-related responsibilities, then all references to sponsors in this guideline also apply to CROs

Table 2: Considerations while choosing a clinical research organisation

What services do CROs in India provide?

Development of biological assays and biopharmaceuticals, product commercialization, pre-clinical and clinical research, clinical trial management, and pharmacovigilance are among the services offered by a CRO. A CRO is a blessing for both pharmaceutical and research needs, as they can multitask within a set timetable.

Fig 2: Services Provided by CRO

The services provided by CRO include:

Approval of Global Clinical Trials (GCT): A GCT approval is crucial for research and clinical studies. The flow of GCTs is as follows:
- Application for a GCT approval includes informed consent form, trial site details, investigator’s brochure, formulation data, preclinical data involving animal pharmacological and toxicological studies, results and clinical report of phase I, II, III trials, etc.
- A checklist of protocol development adjustments and modifications, both major and minor
- A copy of the letter granting authority to conduct clinical trials, the TR 6 challan, and other items are included in the import licence checklist.
- Verifying any site additions, deletions, closures, or changes to the lead investigator.
Safety reporting: A crucial facet of pharmacovigilance is safety reporting. Periodic safety update reports, or PSURs, are due once every six months for the first two years and then once every two years after that, as per schedule Y. PSURs cover the current status of worldwide marketing, updates on safety-related activities, etc.
Test licence: A test licence is essential to import small quantities of drugs, cosmetics, medical devices, etc. for research and development, testing, and analysis. Form 11 contains information on the application’s contents as well as a list of required attachments.
Clinical Trial Registry India (CTRI) Registration: ICMR’s National Institute of Medical Statistics handles the CTRI registration. It provides a free online public record registration mechanism for clinical trials conducted in India, as well as for multinational trials in which India is a participant country. Trial registration in the CTRI was once a voluntary procedure, but it is now a crucial and required step that must be taken. A registration number for every trial being undertaken in India must now be included in publications. The Indian target sample size, trial locations, enrollment date, and Indian investigator details are all included in CTRI. Following registration, it is required to update the trial status on a regular basis with any modifications.
Ethics Committee Registration: In order to receive ethics approval, an application for ethics committee registration must be submitted. To function in India, Ethics Committees overseeing clinical trials, bioavailability, bioequivalence studies, and biomedical research must register with the Central Licensing Authority (CLA). Application via Form CT 01 is required, along with specific details such as committee name, composition, office address, chairperson profile, member information, and standard operating procedures. CLA grants registration in Forms CT-02 or CT-03, valid for five years unless suspended or revoked.

Summary

Sponsors may choose to outsource all or part of the trial-related tasks to a company called a clinical research organisation or contract research organisation (CRO) to manage the clinical trial on their behalf
CROs are a fundamental part of clinical trials that offer a wide variety of services associated with conducting the study that facilitate the work of the Sponsor.
Choosing a good CRO is very important, as much of the success of the study will depend on its management and will help the trial run as smoothly as possible.

Conclusion

A CRO is a blessing for all pharmaceuticals, medical devices, and in-vitro diagnostic kits manufacturers. Research demands an ability to multitask within a set timeframe. Finding a trustworthy, qualified, and skilled CRO, however, requires effort and a thorough survey. CliniExperts decade-long experienced team is there to assist you. CliniExperts offers an organised, methodical, and cooperative approach to managing all regulatory matters. Our team of trustworthy industry professionals helps our clients find the ideal CRO in India for their requirements.

CliniExperts offers a single point of contact for all of your regulatory needs, from application to approval. In the event that there are any revisions or modifications, we offer post-task services to guarantee total client satisfaction well before deadlines.

References

Definition – Contract Research Organisation [Internet]. National Cancer Institute. 2011.
Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/contract-research-organization
WHO. Clinical trials [Internet]. www.who.int. 2023. [cited 17 Nov 2023]
Available from: https://www.who.int/health-topics/clinical-trials#tab=tab_1
European Medicines Agency. Committee for Human Medicinal Products Guideline for good clinical practice E6(R2) Step 5 [Internet]. 2016.
Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-good-clinical-practice-e6r2-step-5_en.pdf
CRO Support, Clinical Trials, Research & Approval – CliniExperts [Internet]. cliniexperts.com. Available from: https://cliniexperts.com/india-regulatory-services/cro/
New Drugs and Clinical Trial Rules, 2019, Ministry of Health and Family Welfare, Notification, G.S.R. 227(E). March 19, 2019. Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf

Understanding the Importance of Real-World Evidence (RWE) in Clinical Trial Solutions

Fri, 05 Apr 2024 10:24:11 GMT

Understanding the Importance of Real-World Evidence (RWE) in Clinical Trial Solutions

Introduction

The process of obtaining data on a treatment’s actual effectiveness from medical records and other sources is known as real-world evidence or RWE. RWE can help researchers make more informed decisions about which therapies to make available by helping them comprehend practical results that go beyond what they see in clinical studies. Moreover, RWE is used by the FDA to help with decision-making about approval of drugs or label modifications.

What is real world evidence (RWE)?

Under Section 505F(b) of the FD&C Act (21 U.S.C. 355g(b)), real world evidence (RWE) is defined as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.

This can help in clinical development, lower medical risks, enhance patient satisfaction, and satisfy payer and regulatory obligations. RWE refers to clinical evidence about the application and possible advantages or disadvantages of a medical procedure or product.

Real-world data (RWD) is transformed, analysed, and interpreted before being used as a basis for RWE, which can then be applied to payer, policy, clinical, or other choices.

Difference between real world evidence and real-world data in clinical studies

	Real world data (RWD)	Real world evidence (RWE)
Definition	Data gathered from a variety of sources about the health of patients and/or the provision of healthcare.	Clinical data regarding the application and possible advantages or disadvantages of a medicinal product.
Source	Registries, collections of electronic health records (EHRs), administrative and medical claims databases can be used for data collection.	Obtained from an analysis of real-world data.

Is real world evidence in clinical trials necessary?

RWE supports inclusion/exclusion criteria early in the clinical trial planning phase by assisting in the identification of suitable patient populations and by using RWD sources.

RWE fosters creative experimentation. Phase II/III hybrid trials can be carried out through the integration of site-based data with registry and electronic health record data. RWE also uses historical or external controls to improve results from single-arm experiments. It also makes it possible to establish external control arms for a more accurate comparison with patients receiving active treatment. Thus, RWE can be a real game-changer in clinical studies.

Importance of real-world evidence in Clinical Trial Solutions

Real world evidence refers to clinical evidence about the application and possible advantages or disadvantages of a medical procedure or product. Value is differentiated by RWE from the industry standard of care, similar items already on the market, and new competitors.

The main importance of real-world evidence in clinical trial solutions include:

Robust technology: The real-world evidence is obtained from an analysis of real-world data (Registries, collections of electronic health records (EHRs), administrative and medical claims databases are used for data collection)
Helps in drug approval: The US Food and Drug Administration (FDA) is willing to use real-world evidence (RWE) for drug approval. RWE helps companies satisfy regulatory standards by facilitating timely and informed decision-making, which is beneficial for drug approval. RWD improves the process from integrated product development planning to regulatory submission, health authority involvement, and regulatory approval. Additionally, evidence-based outcomes research and health economic evaluation are used to show its usefulness.
Supports research in larger populations: We can gain a better understanding of illness situations, patient experiences, and the effects of medicines in larger populations by looking at how pharmaceuticals function in these settings.

Fig : Applications of Real-World Evidence

Summary

CliniExperts is a well-established, 360-degree, regulatory consultants’ agency who have many years of industry expertise for clinical trials in India.

Real-world evidence can provide important insights and advance knowledge of patient experiences and results.
Real-world evidence has been utilised to support regulatory choices, influence designs of clinical studies, enhance clinical guidelines and disease understanding, aid financial conversations and reimbursement decisions, and encourage new applications for already-marketed medicines.
Real-world evidence can supplement and improve knowledge obtained from clinical trials.

Conclusion

In India, CliniExperts is a decade long established regulatory expert offering full-service, 360-degree clinical trial solutions. It can be difficult to navigate the complicated path from the conception to the approval of a product, particularly when faced with strict rules surrounding a clinical trial of a medical device or therapy. We provide an affordable way to expedite this procedure. We give you a strategic edge because of our extensive knowledge of the complexities involved in development, testing, approval, manufacturing, commercialization, and post-marketing surveillance. Count on us to streamline your clinical research services in India to triumph.

Numerous benefits of RWE studies include enhanced external validity, higher generalizability, better comprehension of the treatments’ long-term effects, lower costs associated with drug approval, in-depth examination of the product/treatment in specific patient subgroups, such as those with comorbidities, and faster research findings and knowledge. RWE studies and randomised controlled trials (RCTs) should therefore ideally work together to further explore and offer deeper insights into product effectiveness and safety in particular patient subgroups.

References

FRAMEWORK FOR FDA’S REAL WORLD EVIDENCE PROGRAM [Internet]. www.fda.gov. 2018. Available from: https://www.fda.gov/media/120060/download?attachment
Real-World Evidence [Internet]. U.S. Food and Drug Administration. 2019.
Available from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
Dang A. Real-World Evidence: A Primer. Pharmaceutical Medicine. 2023 Jan;37(1):25–36.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9815890/
Purpura CA, Garry EM, Honig N, Case A, Rassen JA. The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications. Clinical Pharmacology and Therapeutics [Internet]. 2022 Jan 1;111(1):135–44.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299054/
Pharma Regulatory Consultants, Regulatory Affairs Services in India -CliniExperts [Internet]. cliniexperts.com.
Available from: https://cliniexperts.com/

Unlocking the Potential of Real-World Evidence (RWE) in Clinical Trials: A Guide for Sponsors

Fri, 05 Apr 2024 10:24:09 GMT

Unlocking the Potential of Real-World Evidence (RWE) in Clinical Trials: A Guide for Sponsors

Introduction

RWE studies and randomised controlled trials (RCTs) should ideally work together to further explore and offer deeper insights into product effectiveness and safety in particular patient subgroups, such as those with comorbidities.

Overview of Real-World Evidence in Clinical Studies

Real world evidence can help researchers make more informed decisions about which therapies to make available by helping them comprehend practical results that go beyond what they see in trials. Actually, RWE is used by the FDA to help with decision-making about approval of drugs or label modifications.

This is noteworthy because a growing number of medications are being licensed on the basis of RWE rather than the outcomes of clinical trials. A primary reason for this is that organisations struggle to carry out extensive, long-term research on actual patients with real diseases and subsequently publish their findings.

What is real-world evidence (RWE)?

Real-world evidence (RWE) is defined as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials” under Section 505F(b) of the FD&C Act (21 U.S.C. 355g(b)).

Fig : Real-World Evidence

Any pertinent patient-level data not gathered through a standard clinical trial, which is typically randomised, is referred to as real-world data and real-world evidence. The differences in the data obtained from randomised clinical trials, real-world data and real-world evidence is as follows:

	Clinical Trials	Real world data (RWD)	Real world evidence (RWE)
Overview	Clinical trials are investigations conducted to evaluate a medicinal, surgical, or behavioural intervention.	Regularly gathered from a range of sources about the state of health of patients and/or the provision of healthcare.	Clinical data regarding the application and possible advantages or disadvantages of a medicinal product.
Source	Results of trials conducted on humans.	Registries, collections of electronic health records (EHRs), administrative and medical claims databases can be used for data collection.	Obtained from an analysis of real-world data.

Benefits of Real-World Evidence for Sponsors

Understanding the true efficacy and safety profile of the product is made easier by utilising real world data and evidence to bridge the gap left by randomised clinical trials (RCTs) in current clinical understanding. Some of the benefits of clinical trials in the medical field using real world evidence include:

Exploring various facets of health and illness, including epidemiology, disease burden, treatment patterns, safety, treatment outcomes, long-term outcomes, and patient-reported outcomes like satisfaction, quality of life, medication adherence, and patient experience.
Obtaining deep insights into the financial aspects of a medical product.
Reduction of trial time and associated costs in early stages of drug development.
Enhancing regulatory and clinical decision making, such as the approval of medicinal items, are increasingly being supported by RWE.
Improving the way RCTs are conducted.

At each stage of clinical trials, real world evidence provides various advantages for sponsors. This includes:

Prior to product development	At or after marketing authorization	After launch of product
Prevalence, incidence, and unmet medical need of natural history of disease	Insights into early and/or long-term clinical experience	Health outcomes and comparative effectiveness & support for increasing the number of indications
Recognizing the existing service infrastructure and whether any modifications are necessary to provide the new medication	Prospective research on safety surveillance	Compliance with product labels or treatment guidelines
Generating hypotheses for prospective trials.	Evidence to show improved health outcomes, resource conservation, and patient acceptability	Recognizing inadequate dosage or course of treatment
	Identification of undiagnosed/untreated patients (or “unmet need”).	Monitoring safety, particularly unusual or rare adverse reactions.

How can CliniExperts help?

With more than ten years of experience in the industry, CliniExperts is a 360-degree comprehensive clinical studies solutions provider. It is a one stop solution service and ensures a simple, and hassle-free process to obtain the required permissions and supporting documentation for obtaining the best clinical research services in India.

Obtaining the required licences and approvals for your products is made simple by the highly skilled team and extensive industry networks. With the help of CliniExperts you are assured a smooth experience in receiving necessary licences and approvals for your products.

Summary

The FDA has a long history of monitoring and assessing the post market safety of authorised medications by using real-world data (RWD) and real-world evidence (RWE).
The process of obtaining data on a treatment’s actual effectiveness from medical records and other sources is known as “real-world evidence,” or RWE.
Numerous benefits of RWE studies include enhanced external validity, higher generalizability, better comprehension of the long-term effects of treatment, in-depth examination of the product/treatment, and faster research findings and knowledge.

Conclusion

A valuable resource for helping doctors and patients make educated treatment decisions is real-world evidence. It is important to keep in mind that RWE can frequently complement and enhance clinical trials to further develop therapeutic understanding and research.

References

Real-World Evidence [Internet]. U.S. Food and Drug Administration. 2019.
Available from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
FRAMEWORK FOR FDA’S REAL WORLD EVIDENCE PROGRAM [Internet]. www.fda.gov. 2018.
Available from: https://www.fda.gov/media/120060/download?attachment
Clinical trials [Internet]. WHO. 2023.
Available from: https://www.who.int/health-topics/clinical-trials#tab=tab_1
Dang A. Real-World Evidence: A Primer. Pharmaceutical Medicine. 2023 Jan;37(1):25–36.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9815890/
Bhatt A. Conducting real-world evidence studies in India. Perspectives in Clinical Research [Internet]. 2019 [cited 2019 May 12];10(2):51.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463503/

Are Clinical Trials safe? What are the Safety Measures of Clinical Trials?

Wed, 14 Feb 2024 12:56:09 GMT

Are Clinical Trials safe? What are the Safety Measures of Clinical Trials?

Introduction

In a clinical trial, the safety and well-being of the volunteer participants is paramount. All researchers, investigators and healthcare workers involved in the clinical study must ensure that the risks of a trial do not outweigh its benefits. Participant inclusion and exclusion criteria are designed accordingly. This is done by sharing complete information of the clinical trial with the participants and their acknowledgement that they understand the risks involved. The participants are made aware of all the procedures, benefits and risks associated with the study. There are also many stakeholders who monitor trials to protect the participants of a clinical study. A regulatory firm like CliniExperts can aid sponsors and stakeholders in conducting clinical trials safely and successfully.

Clinical research offers a lot of hope to patients, researchers, sponsors and all the stakeholders. With the help of clinical trials, patients gain active treatment while scientists and researchers gain insights into the treatment of the particular condition.

Clinical trials also help clinical research stakeholders in successfully translating years of drug research, into finally launching an effective and safe drug into the market and helping patients to get the outcomes they deserve.

Are Clinical Trials Safe?

Participants of a clinical trial can first ensure their own safety by collecting thorough knowledge and information about the clinical trial. This is done with the help of an informed consent form (ICF) provided to them by the investigator and HCPs of the trial.

The informed consent form is a regulatory document which includes:

Details, purpose, duration, procedures of a clinical study.
Risks and benefits associated with the study.
Contact details of the clinical trial personnel.
Participants are free to clear all their doubts and seek additional information related to the study before signing the form and enrolling in the study. They are also free to withdraw from the study at any point of time during the trial.

The following table describes the safety parameters along with its duration in each phase of a clinical trial.

Safety Parameters in a Clinical Trial
Pre-clinical	Lab studies	Several years
Phase I	Human safety	Days or weeks
Phase I/II	Expanded safety	Weeks or months
Phase III	Efficacy & Safety	Several years

Table 1: Safety parameters in a clinical trial

Benefits of Participating in a Clinical Trial

There are a multitude of benefits for patients participating in a clinical trial. Some of these are:

They help patients suffering from a particular disease (E.g.: cancer) to obtain active treatment and careful medical attention from physicians and HCPs.
Patients also receive access and benefits to the new drug/treatment before it launches into the market. They are given additional information, resources, participation in support groups etc.
They are given careful attention from physicians and their health is regularly monitored.

Risks of Participating in Clinical Trial

Along with its benefits, one cannot ignore the possible risks occurring in a clinical trial. A few of them are:

Trials do involve tests/ procedures which may cause side effects, mild complications, and even serious complications such as AEs and serious adverse events (SAEs) to the patients.
The new drug/treatment may not be as effective or may not work as compared to the standard, conventional treatment.
The new drug/treatment involved in a clinical trial may cost the patients more time as compared to them receiving the standard treatment such as additional hospital visits, blood tests, complex schedules, and procedures etc.

Fig. 1: Risks involved in clinical trials

How is the Safety of Participants Protected?

In order to keep the trial participants as safe as possible, there are stringent rules and regulations set in a carefully designed and executed research protocol which must be followed by all the investigators, HCPs, trial patients etc.

Fig. 2: Safety measures implemented in clinical trials

There are 3 main safeguard groups which protect participants namely:

Institutional Review Boards (IRBs): IRBs consist of a committee of experts such as physicians, scientists, authoritarians etc. who ensure that the clinical trial is designed with the highest ethics, and accuracy. They also help ensure that the rights, safety, and well-being of participants are protected at all times. IRBs review and approve clinical trial before commencement.
Regulatory authorities: Authorities like the Food and Drug Administration (FDA), European Medicines Agency (EMA), Central Drugs Standard Control Organization (CDSCO) in India, etc. are responsible for approving clinical trials, providing guidance on trials’ processes, ethical requirements etc. All these are performed to safeguard the trial participants.
Data Safety and Monitoring Boards (DSMBs): DSMBs are made up of experts who closely monitor and inspect a clinical trial as it progresses through the various phases. They are responsible for reviewing trial data, offering insights to the investigators, watching over the safety of the patients, and have the power to stop the trial early, if needed.

How CliniExperts can help?

CliniExperts is a well-established, 360-degree, regulatory consultants’ agency who have many years of industry expertise for clinical trials in India.

They provide faster and better solutions related to clinical trial safety management needs of global local sponsors.
They help in launching the sponsors’ drugs to the market by supporting the products’ life cycle via pharmacovigilance and regulatory activities.

Summary

The safety of participants in a clinical trial is of prime importance. This is why every clinical study goes through stringent review and quality control processes in order to get approved by the regulatory authorities. The healthcare professionals (HCPs) involved in a clinical trial are also trained to always protect the rights, safety, and well-being of participants.
For participants to take part in a clinical trial, they must be given complete and accurate information about its processes. An informed consent form helps achieve this and confirms the participation of the volunteer. It ensures that they are completely aware of the benefits and risks associated with the study.
There are many benefits for patients participating in clinical trials such as better medical knowledge, free treatments, free tests, etc.
Along with their benefits, clinical trials also possess many potential risks such as ineffectiveness, adverse events (AEs) etc.
The Drugs and Cosmetics Act 1940 & Rules 1945 and 21 C.F.R sets out strict rules and for every clinical trial to ensure the safety of participants. The safeguards of a clinical trial are the Institutional Review Boards (IRB), regulatory authorities and Data Safety and Monitoring Boards (DSMB).
CliniExperts’ regulatory services can provide an all-in-one solution to all the safety needs of a clinical trial conducted by sponsors across India.

Conclusion

In conclusion, the safety of participants in a clinical trial takes precedence over all other aspects of the trial as it is one of the main principles of Good Clinical Practice (GCP). Hence, CliniExperts can provide seamless guidance and support to the participants and sponsors associated with a clinical study.

References

What are Clinical Trial Phases?

Wed, 14 Feb 2024 12:55:54 GMT

What are Clinical Trial Phases?

Introduction

Clinical trials are conducted in four or more different phases to evaluate an investigational new drug (IND) and its effect on human health. Through these phases, the drug is discovered, the disease needing treatment is identified, and finally, the drug is submitted for regulatory approvals and launched for sale in the market. CliniExperts, with its regulatory and clinical trials’ expertise can help in smoothly receiving necessary approvals from the regulatory authorities in India to launch drugs/devices in the Indian market.

Fig. 1: Phases of clinical trials

Many medical conditions plague humans that still do not have a clear treatment. The development of a drug involves the entire cycle right from discovering a molecule to ensuring it is safe for human use and then launching it in the market for treatment of the said medical condition.

In India, the regulatory authority which oversees clinical trials across the country is the Central Drugs Standard Control Organization (CDSCO). Trials must stringently follow guidelines laid by CDSCO in order to establish the most beneficial and effective form of treatment and get timely clearance for market launch.

Processes in a Clinical Trial

In a clinical trial, the volunteer participants are divided into 2 or more groups:

Most of the clinical trials undergo randomisation where the participants are randomly allocated to different treatment groups.
This ensures that the participants do now know whether they are given the IND or not. This is known as blinding.
In some trials, double blinding method might be used. Here, the participants as well as the investigators (physicians) don’t know who receives the IND.
Out of these, one of the groups is typically given a control i.e., they receive the conventional form of the treatment which acts as a standard to gauge the effects of the IND.
In some trials, the participants in the control group may not be given any treatment at all, also called as placebo i.e., blank pills. The placebo resembles the IND but has no therapeutic effect.

Pre – Clinical Phases (Phase 0) of a Clinical Trial

Pre-clinical studies are an important pre-requisite for clinical trials as they discover the active drug to resolve treatment needs of a particular disease.

Early drug discovery: In this phase, the researchers identify and study a target gene/protein of an active drug which has a curable effect on a disease/condition.
Pre-clinical research: Pre-clinical studies are required by all regulatory authorities as they help in predicting the outcome of the treatment and the side effects associated with the IND. They consist of in-vitro and in-vivo studies performed on animals.
Regulatory approval: After pre-clinical research, the IND must now be approved by the regulatory authorities to proceed to human clinical trials. While submitting the IND application, it must contain information on animal pharmacology and results of the toxicology studies, manufacturing information, clinical protocols, and investigator information.

The Phases of a Clinical Trial

After pre-clinical studies, the IND is next evaluated for its safety, efficacy, risks, and benefits in humans through a series of 4 phases of studies which are based on a carefully designed research protocol. These phases are:

Phase I: The IND is tested on a small group of healthy participants to evaluate the safety and side effects of the drug.
Phase II: After successful completion of Phase I studies, the IND is tested in a larger group of participants for efficacy. They are patients suffering from the respective condition for which the drug is targeted to assess efficacy.
Phase III: This is followed by Phase III studies where the IND is tested on a much larger group of participants (hundreds to thousands) where large amounts of qualitative and quantitative information about its safety and efficacy are evaluated.
Phase IV: Post-marketing research is conducted in this phase. Here, the IND is evaluated for its long-term safety, efficacy, benefits, and risks.

Parameters	Phase I	Phase II	Phase III	Phase IV
Duration	Upto 1 month	Several months	Several years	Ongoing (following regulatory approval)
Population	Healthy individuals	Individuals with target disease	Individuals with target disease	Individuals with target disease and new age groups, genders, etc.
Sample Size	20 to 80	200 to 300	Hundreds to thousands	Thousands

Table 1: Phases of a clinical trial

Post – Clinical phases of a Clinical Trial

After the successful completion of a clinical trial, the IND now needs approval by the regulatory bodies in order to be launched in the market.

Fig. 2: Stages of Post-Clinical Phase

New Drug Application (NDA): An NDA is made by the sponsor to gain regulatory approvals of their tested drug. This NDA contains adequate information about the IND so that the regulatory authorities can deem it safe and effective for human use.
Product Launch: After the IND obtains approval, several operations are carried out for finally launching the drug into the market. This includes production, packaging, storage, marketing etc.
Post Marketing Safety Surveillance: In this phase, the pharmacovigilance (PV) department of the sponsor identifies and gathers safety information and the risk-benefit ratio of the IND after it has been launched into the market. This is done to check for any complaints or reports regarding the safety and efficacy of the drug as used by real patients.

How CliniExperts can help in Clinical Trials

CliniExperts is an established 360-degree regulatory consultancy with expertise in conducting successful clinical trials in India. We assist global and local sponsors in the following trial procedures:

Regulatory approvals and obtaining licenses for importers and manufacturers.
Storage of INDs and other clinical trials’ supplies.
Trial site management services.
Post – approval services.
Pharmacovigilance activities etc.

Fig. 3: Overview of phases of Clinical Trials

Summary

A clinical trial is a research study conducted to analyse drugs and treatments and their effect on human health. It involves participation of human volunteers and is based on a research protocol.

In a clinical trial, the participants are divided into 2 or more groups using randomisation, blinding, double – blinding, administration of placebo, etc. These techniques ensure the trial results are objective.

There are 4 main phases of a clinical trial. These include pre-clinical and post-clinical trial phases.

The pre-clinical phase further consists of 3 stages aimed at discovering the new drug, predicting treatment outcomes, and obtaining regulatory approval.

The pre – clinical phase is then followed by 4 biomedical trial phases. Each phase has different pre – defined conditions to evaluate different aspects of the Investigational New Drug (IND).

Next is the post – clinical studies phase (with 3 stages) where the IND is prepared for approval by the regulatory authorities, launching in the market and inspection of its safety post marketing.

The clinical team of CliniExperts can provide regulatory, technical and project management services to help sponsors conduct their clinical trials efficiently.

Conclusion

In conclusion, the successful development and launch of an IND revolves around how regulated and efficient the phases of a clinical trial are. Hence, a regulatory consultant like CliniExperts can help sponsors navigate and smoothly conduct all their clinical trial phases in India.

References

https://cliniexperts-research.com/clinical-trial-expert-articles/drug-development-process/

Clinical Trial Methods – Quantitative / Qualitative Clinical Research

Tue, 23 Jan 2024 10:04:42 GMT

What is Clinical Trial Method?

Introduction

Clinical trial methods integrate strategies to achieve valid conclusions about trial objectives and safeguard participants, utilizing both quantitative and qualitative research approaches. Emphasising the significance of statistical reasoning in clinical research, a clinical trial method is integral to the methodology of clinical trials. Therefore, understanding the various types of clinical trial methods is crucial for conducting effective clinical research. Clinical trials are essential in comparing the impacts of one intervention against another, involving participants who may be patients, healthy individuals, or a combination of both. They play a crucial role in advancing our understanding of human health and disease, as well as in the development of innovative and effective therapies. This article delves into a comprehensive exploration of clinical trial methods highlighting their importance in clinical trials.

Importance and Considerations in Methodology

Conducting clinical research necessitates a systematic approach, involving meticulous planning, execution, and sampling to ensure the acquisition of reliable and validated results. Researchers must possess a comprehensive understanding of various research methodologies. The choice of a specific methodology is contingent upon factors such as:

Hypothesis under investigation
Research question or problem statement
Study objectives
Study’s nature
Participant pool
Controls
Intervention
Variables

The credibility and validity of results hinge on a well-defined overall study design, encompassing clear objectives, reproducible methodology, careful data collection and analysis to minimise errors and bias, and effective reporting of findings. Therefore, the selection of an appropriate methodology is crucial for obtaining valid results, emphasising the necessity for researchers to have a solid grasp of research methodology.

Types of Clinical Research

Clinical research can be broadly classified as quantitative or qualitative based on study design. Further categorisation of quantitative into descriptive or analytical considers data collection techniques and the direction of causality, including factors like time relationships.

Fig. 1: Types of Clinical Research

Quantitative Clinical Research

Quantitative Clinical Research involves the systematic collection and analysis of numerical data to quantify relationships, patterns, and trends within a larger population.

Descriptive Research

Descriptive research involves recording and reporting new or unusual events, like disease prevalence in a family, without randomisation. It includes case reports for individual patients, case series for common characteristics, and surveillance studies for continuous monitoring of disease occurrence in a population.

Analytical Research

Analytical studies, unlike descriptive studies, incorporate control groups for comparative evaluations. These can be experimental (intervention) studies or observational (non-intervention) studies.

Observational Studies

Non-interventional studies where patients receive therapy based on diagnosis and therapeutic need. They include therapeutic, prognostic, and observational drug studies, case series, and single case reports.

Fig. 2: Classification of Observational Studies

Observational studies can be broadly classified as individual and aggregate studies:

Aggregate Observation Studies

These studies aggregate individual-level data based on geographic area, year, or other parameters. They provide insights into the distribution of diseases in populations, such as aggregating data on COVID-19 or cancer registries.

Individual Observation Studies

These studies analyse disaggregated individual results, grouping subjects based on outcomes or exposures. These are further divided into the following:

Case-control studies group subjects based on selected outcomes, comparing exposure experiences between case and control groups.
Cohort studies group subjects based on exposure, allowing the study of multiple outcomes.
- Retrospective cohort studies look back at archived data, while prospective cohort studies follow cohorts over time.
Cross-sectional studies assess exposures and outcomes concurrently, providing prevalence data but not causation insights.

Experimental Studies

Experimental studies encompass intervention trials, comprising preclinical trials conducted on animals and clinical trials conducted on humans. They employ main designs such as randomised controlled trials and non-randomised controlled trials.

Fig. 3: Classification of Experimental Studies

Non-randomised Studies

In these studies, the study population is chosen based on predetermined criteria, and intervention is prescribed according to the course of the disease. In cases where randomisation is not feasible or ethical, such as surgical interventions for specific patient groups, non-randomised designs are employed. Non-randomised studies can be categorised into three additional types:

Quasi-experiment: This involves assigning exposure to the intervention similar to a randomised controlled trial, but subjects are not randomised.
Field Trial: These large-scale studies assess therapeutic interventions, such as the efficacy of COVID-19 vaccines. They require numerous samples, especially when the incidence of a particular disease is low.
Community Trial: Interventions are allocated to a community group, as seen in testing the effects of water fluoridation on communities.

Randomised Controlled Trials

These trials typically involve random division of study participants into two groups, with the experimental group receiving the intervention and the control group not receiving it (or possibly receiving an existing standard of care). The assignment of the intervention is generally randomised. Subsequently, participants are monitored over a period to evaluate changes in outcomes within both groups. The comparison of outcomes in these groups enables an assessment of the intervention’s impact. As these studies are conducted with a prospective approach, wherein the investigator allocates the intervention, this study type offers a robust level of evidence and is frequently regarded as the gold standard. Randomised controlled trials can be categorised into four additional types:

Parallel Group Design: This is the most common method. In this design, a substantial number of subjects or patients are enrolled in two groups (experimental vs control), followed up, and observed for outcomes concurrently over a designated period.
Crossover Design: This design involves the sequential administration of two interventions in the two enrolled groups (experimental vs control), and the assessment of their effects. It applies to drugs with reversible and transient effects. Notably, the number of required patients is smaller compared to other designs.
Factorial Design: This study design lets investigators see how one or more interventions; both together affect the group of participants or patients. There are generally 4 groups in this design. One group receives both interventions, the other two groups receive one intervention each, and the last group is the control group.
Withdrawal Group Design: In this design type, interventions for chronic diseases are either halted or the dosage is reduced. This approach proves valuable for evaluating the optimal intervention duration for chronic conditions and assessing interventions for which conclusive evidence in the literature is lacking.

Quantitative Clinical Research

On the other hand, qualitative Clinical Research focuses on exploring and understanding the complexity of human experiences, behaviors, and perspectives through in-depth, non-numerical data collection and analysis.

Conclusion

Clinical research involves diverse methodologies, with descriptive studies capturing new events, while analytical studies employ control groups for comparative evaluations. Observational studies, categorised as aggregate and individual, provide valuable insights. Experimental studies, including randomised controlled trials and non-randomised studies, play a crucial role in intervention research. Non-randomised studies, like quasi-experiments and community trials, offer flexibility in design. While, randomised controlled trials with investigator-allocated interventions are highly regarded for providing robust evidence, often considered the gold standard.

Types of Clinical Research
Quantitative					Qualitative
Descriptive	Analytical
Case report Case Series Surveillance studies	Observational Studies		Experimental Studies
	Individual	Aggregate	Non-Randomised Studies	Randomised Controlled Trials
	Case-control Studies Cohort Studies Cross-sectional Studies	Quasi Field Trial Community Trial	Parallel Group Design Crossover Design Factorial Design Withdrawal Group Design

Table 1: Exploring the landscape of clinical trials: From diverse observational studies to the gold standard of prospectively conducted experimental trials

References

Chen, Ding-Geng & Peace, Karl. (2010). Clinical Trial Methodology. [Internet]. [cited 2023 Dec 18]. Available from: https://www.researchgate.net/publication/267764342_Clinical_Trial_Methodology
Kiani AK, Naureen Z, Pheby D, et al. Methodology for clinical research. J Prev Med Hyg. 2022;63(2 Suppl 3):E267-E278. Published 2022 Oct 17. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9710407/
Clinical trials. NHS. [Internet]. [cited 2023 Dec 17]. Available from: https://www.nhs.uk/conditions/clinical-trials/
Lesson 1: Clinical Trials Overview. [Internet]. [cited 2023 Dec 18]. Available from: https://ccrod.cancer.gov/confluence/download/attachments/164235639/EUPATI%20Core%20Educational%20Materials%20for%20REiNS%20%28002%29.pdf?version=1&modificationDate=1539610009020&api=v2
Setia MS. Methodology Series Module 4: Clinical Trials. Indian J Dermatol. 2016;61(4):393-402. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966397/

What Are the Technology Solutions for Clinical Trials?

Mon, 22 Jan 2024 14:36:49 GMT

What Are the Technology Solutions for Clinical Trials?

Introduction

Technological solutions continue to foster medical research, especially the clinical trial approach. Much like the impact it has had on our daily lives, digital technology has significantly revolutionised the medical research landscape. Introducing technologies into clinical trials has influenced them in numerous ways, such as bringing about changes in the methodological tools and modes of delivering interventions in clinical trials.

Clinical trials play a key role in advancing medical research. In fact, randomized controlled clinical trials serve as a gold standard for establishing evidence in medical research. However, traditional approaches are often plagued by challenges that we will explore in the next section. Rapid technological evolution provides innovative solutions to many of these challenges, thereby reshaping the landscape of clinical trials. This blog explores the diverse array of technological solutions that transform clinical trials and the benefits they bring to the table.

Current Challenges in the Clinical Trials

Traditional clinical trial processes face several hurdles, including slow recruitment, data management issues, and resource-intensive procedures. Slow recruitment often leads to delays in trial completion, hindering the progress of drug development. Additionally, the manual handling of data increases the risk of errors, impacting the overall quality of the trial results. The high costs associated with traditional methods limit accessibility to clinical data and slow down the pace of medical advancements. With promising technological solutions, almost all the steps in a clinical trial can now be performed virtually, eliminating the necessity of in-person interactions. Various digital health technologies as well as technological solutions are employed for clinical trial processes and delivery of interventions.

Technology Solutions Transforming Clinical Trials

The applications of digital technology solutions in clinical trials include:

Fig. 1: Applications of Digital Technology

1. Electronic Data Capture (EDC)

Traditionally, clinical trial data collection relied on manual processes involving paper forms, leading to inefficiencies, data errors, and delays. Electronic Data Capture (EDC) revolutionizes this process by digitizing data entry, enabling researchers to collect, validate, and manage data electronically. The integration of EDC with other systems ensures seamless data flow, reducing the risk of errors and expediting the overall data collection process.

2. Mobile Technologies for Electronic Consent, Data Collection, and Intervention

Mobile technology plays a pivotal role in revolutionizing the informed consent process, reaching a broader audience with the electronic consent (eConsent) tool. It also serves as a versatile tool for delivering interventions and monitoring adherence, and is a robust platform for managing large volumes of data.

3. Integration of Electronic Health Records (EHR)

The integration of Electronic Health Records (EHR) with clinical trials has marked a significant leap forward in enhancing the quality and comprehensiveness of patient data. By leveraging real-time patient information from EHR systems, researchers gain a more holistic view of participants, contributing to informed decision-making, better patient outcomes, and better collaboration between healthcare providers and research teams.

4. Decentralized and Virtual Trials

The traditional model of clinical trials required participants to make frequent visits to trial sites, posing challenges in terms of accessibility, patient recruitment, and diversity of the study population. Decentralized and virtual trials bring about a paradigm shift by leveraging digital technologies to conduct trials remotely.

5. Remote Patient Monitoring (RPM)

Remote patient monitoring (RPM) utilizes connected devices such as smartphones and sensors to collect patient data outside of conventional clinical settings. Wearable devices, such as fitness trackers or smartwatches, allow for continuous monitoring of vital signs and other relevant health metrics. This real-time data not only enhances the quality of data collected but also provides valuable insights into a patient’s health, contributing to more personalized and effective care.

6. Telemedicine Platforms and Wearable Devices

Telemedicine platforms have become integral in clinical trials, facilitating virtual consultations between researchers and participants. The use of wearable devices, synced with these platforms, enables continuous data collection, offering a comprehensive understanding of a participant’s health status. These technologies not only improve patient engagement but also reduce the burden of physical visits, enhancing the overall participant experience.

7. Blockchain Technology in Clinical Trials

Ensuring the security and transparency of clinical trial data is paramount for maintaining integrity and fostering trust among stakeholders. Blockchain technology, with its decentralized and tamper-resistant nature, has emerged as a potent solution. Blockchain serves as an immutable ledger that records transactions securely. Applied to clinical trials, it provides an unalterable record of data, reducing the risk of fraud and ensuring the integrity of trial results. This not only enhances data security but also supports transparency and accountability throughout the entire trial process.

8. Predictive Analytics and Artificial Intelligence

The integration of predictive analytics and artificial intelligence (AI) is transforming clinical trials by enabling data-driven, informed decision-making throughout the trial lifecycle. AI algorithms analyze vast data sets to better identify suitable candidates for clinical trials, allowing researchers to tailor recruitment strategies and accelerating the trial initiation process. Additionally, AI-driven insights contribute to improved participant retention by identifying potential challenges and implementing proactive measures. From identifying potential risks to optimizing trial protocols, AI enhances the efficiency and effectiveness of decision-making processes, ultimately contributing to the success of clinical trials.

These innovations not only address existing challenges but also open the door to more efficient, patient-centric, and impactful clinical trials, thus holding the potential to improve patient outcomes.

Benefits and Future Implications

The integration of technology solutions in clinical trials brings forth numerous benefits, such as:

Fig. 2: Benefits of Technology Solution

Efficiency: Streamlined processes and automated workflows reduce the time and resources required for trial conduct.
Patient-Centricity: Decentralized and virtual trials enhance patient convenience, leading to increased participation and diversity in the study population.
Data Quality: Electronic data capture and integration with EHRs improve the accuracy and completeness of trial data.
Cost Reduction: Technology-driven solutions reduce the overall costs associated with clinical trials.
Reduced burden of data collection: Digital technologies also reduce the burden of data collection by synchronizing data capture models with existing platforms on registries, EHRs, smartphones, and administrative databases.

As we stand on the cusp of a new era in clinical research, the integration of technology solutions in clinical trials offers a promising path forward. From electronic data capture to blockchain technology and AI-driven decision-making, these innovations are revolutionizing the way trials are conducted. Embracing these advancements not only addresses current challenges but also paves the way for a future where clinical trials are more efficient, inclusive, and impactful. The ongoing synergy between technology and healthcare holds the potential to accelerate medical discoveries and improve patient outcomes on a global scale.

Fig. 3: Integration of digital technology in the clinical trial transforms the trial landscape, thereby enhancing efficiency, data quality, and patient-centricity

Technology Solution

Benefits

EDC

Digitizes data entry, reducing errors

– Streamlined workflows

– Expedited data collection

Mobile Tech

Enables eConsent, interventions, and data collection

– Improved consent

– Versatile tool

– Efficient data management

EHR Integration

Integrates EHR for holistic patient view

– Informed decision-making

– Streamlined data acquisition

Decentralized trials

Leverages tech for remote trials, improving accessibility

– Enhanced patient convenience

– Increased diversity in the study population

RPM

Uses connected devices for data collection outside clinics

– Continuous vital sign monitoring

– Enhanced data quality

Blockchain

Ensures secure, transparent trial data management

– Data security

– Fraud prevention

– Accountability enhancement

Predictive Analytics & AI

Drives data-driven decision-making, and participant insights

– Efficient candidate identification

– Improved retention

– Enhanced decision-making

Table 1: Technology Solutions in Clinical Trials

References

Mittermaier M, Venkatesh KP, Kvedar JC. Digital health technology in clinical trials. NPJ Digit Med. 2023 May 18;6(1):88. Available from: https://www.nature.com/articles/s41746-023-00841-8
Rosa C, Marsch LA, Winstanley EL, Brunner M, Campbell ANC. Using digital technologies in clinical trials: Current and future applications. Contemp Clin Trials. 2021 Jan;100:106219. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8734581/
Mitsi G, Grinnell T, Giordano S, Goodin T, Sanjar S, Marble E, Pikalov A. Implementing Digital Technologies in Clinical Trials: Lessons Learned. Innov Clin Neurosci. 2022 Apr-Jun;19(4-6):65–9. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341314/
Askin S, Burkhalter D, Calado G, El Dakrouni S. Artificial Intelligence Applied to clinical trials: opportunities and challenges. Health Technol (Berl). 2023;13(2):203-213. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9974218/

What is a Clinical Trial Treatment?

Mon, 22 Jan 2024 14:12:21 GMT

What is a Clinical Trial Treatment?

Introduction

A clinical trial or a clinical trial treatment involves researching to examine the effects of new tests and treatments on human health outcomes. Clinical trial treatments, as well as clinical trials in general, go through meticulous design, thorough review, and rigorous approval processes before initiation. When conducted with precision, clinical trial treatments stand as a quick and secure method for discovering innovative treatments and enhancing healthcare practices. Individuals willingly participate in these clinical trial treatments to assess various medical treatments, encompassing drugs, surgical and radiological procedures, cellular and biological products, devices, behavioural treatments, and preventive care. This article delves deeper into the world of clinical trial treatments, exploring their significance and implications.

Fig. 1: Clinical Trial Treatment assess these aspects

Overview of a Clinical Trial Treatment

It is crucial to evaluate the potential impact of a new treatment on the overall health of a population before incorporating it into that population. By doing so, the goal is to understand the general health of the population, following the adoption of the treatment. This is done in comparison with what the general health would have been without the treatment. However, in reality, determining the exact outcome is challenging due to the counterfactual nature of the scenario. Nevertheless, the responsibility of assessing the treatment’s impact to the best extent possible is tasked to the regulatory governmental agencies that approve new treatments. They aim to make informed judgments on the effects of the treatment on the population’s health.

Importance of a Clinical Trial Treatment

Within the realm of medicine and healthcare, clinical trials play a pivotal role in discerning the efficacy and safety of medical treatments. These trials serve as the paramount method for uncovering what truly works in the treatment of diseases (such as cancer). The fundamental questions addressed in clinical trials are pivotal in shaping the landscape of medical practices:

Comparing with Standard Treatments:

Is the new treatment superior to the standard treatment for a particular disease?
Do clinical trials demonstrate the superiority of a new drug, treatment, or combination over current practices?

Assessing Safety:

Is the new treatment considered safe?
Acknowledging that no treatment is entirely risk-free, do the benefits of the new treatment outweigh the potential risks?

Evaluating Treatment Efficacy:

Does the new treatment demonstrate effectiveness in people?
Will the doctors consider its effectiveness?
To what extent does it outperform existing treatments?
If not superior, is it at least as effective while causing fewer side effects?
Can it benefit individuals who do not respond to current treatments?

The importance of clinical trial treatments lies in systematically addressing these critical questions. This process is often conducted through different phases, each meticulously designed to balance the quest for knowledge with the utmost safety of participants. The collective results from these phases contribute to establishing the reasonable safety and efficacy of the new drug or treatment. This critically helps in guiding advancements in medical care.

Requirements for a Clinical Trial Treatment

Fig. 2: Requirements for a Clinical Trial Treatment

Moving to Clinical Trials:

The inception of a clinical trial often originates in the laboratory, following pre-clinical findings that indicate the potential safety and efficacy of a new drug or treatment for use in people. After rigorous testing in both laboratory and animal settings, the most promising treatments advance to clinical trials.

Regulatory Approval:

In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for approving clinical trials as well as the import, manufacture, and sale of new drugs. The CDSCO is supported in this process by subject expert committees, and the Indian Council of Medical Research (ICMR) is involved in this assessment.

Inclusive Participant Criteria:

Recognising the diverse ways individuals experience diseases, clinical trials must encompass participants with varied lived experiences, living conditions, and demographic characteristics. This inclusivity extends to factors such as race, ethnicity, age, sex, and sexual orientation, ensuring that scientific advances benefit all communities equitably.

Informed Consent Practices:

Incorporating a comprehensive practice of informed consent is imperative, aligning with legal objectives to safeguard patients’ rights, ethical principles supporting autonomous decision-making, administrative goals for efficient healthcare, and interpersonal objectives aimed at building the trust necessary for the successful implementation of novel treatments.

Protocol, Eligibility Criteria and Documentation:

Clinical trials adhere to a meticulously crafted plan called a protocol, aimed at striking a balance between potential benefits and risks for participants while addressing specific research queries. The protocol outlines the study’s objective, eligibility criteria for participants, safeguards against risks, specifics of tests and treatments, expected trial duration, and the information to be collected. Further, the use of training and validation data sets is essential to evaluate the accuracy of an analysis. Statistical analysis involves processing and interpreting quantitative data to understand the treatment course. In clinical study reports, this includes statistical validation and scientific interpretation of collected data to guide treatment decisions.

Funding and Resources:

Entities responsible for initiating, overseeing, or funding clinical trials, known as sponsors, can encompass individuals, institutions, companies, government agencies, or other organisations. Their role involves managing and financing the clinical trial, although they are not directly involved in conducting the research.

Considerations Before Clinical Trial Enrolment

Individuals undergoing the experimental treatment may experience discomfort or encounter side effects, varying in intensity from mild to severe. There is a possibility that the experimental treatment may not prove effective, or it might not surpass the efficacy of the standard treatment. Therefore, before entering a clinical trial, thoroughly discuss your questions and concerns with the healthcare team conducting the trial. Consult your healthcare provider to assess the trial’s suitability for your current treatment, ensuring clarity on trial procedures, healthcare provided, associated costs, and the potential benefits and risks of participation.

Conclusion

Clinical trial treatments are a crucial avenue for medical progress, rigorously designed and regulated. Sponsors, whether individuals or organisations, play a pivotal role, and potential participants should carefully weigh the implications before joining. Open communication with the trial healthcare team ensures informed decisions, and regulatory approval, such as from the CDSCO, adds a layer of scrutiny, emphasising the delicate balance between scientific progress and participant well-being.

Overview of a Clinical Trial Treatment
Importance of a Clinical Trial Treatment	Requirements for a Clinical Trial Treatment	Considerations Before Clinical Trial Enrolment
Comparing with Standard Treatments	Moving to Clinical Trials	Implications and Risks
Assessing Safety	Regulatory Approval
Evaluating Treatment Efficacy	Inclusive Participant Criteria
	Informed Consent Practices
	Protocol, Eligibility Criteria and Documentation
	Funding and Resources

Table 1: Balancing Progress, Ethics, and Well-being in Clinical Trials

References

Clinical trials. World Health Organization. [Internet]. [cited 2023 Dec 17]. Available from: https://www.who.int/health-topics/clinical-trials
Basics about clinical trials. FDA. [Internet] [cited 2023 Dec 17]. Available from: https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials
National Research Council (US) Panel on Handling Missing Data in Clinical Trials. The Prevention and Treatment of Missing Data in Clinical Trials. Washington (DC): National Academies Press (US); 2010. Appendix A, Clinical Trials: Overview and Terminology. Available from: https://www.ncbi.nlm.nih.gov/books/NBK209903/
Types and phases of clinical trials. American Cancer Society. [Internet]. [cited 2023 Dec 17]. Available from: https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html
The Basics. NIH. [Internet]. [cited 2023 Dec 17]. Available from: https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
Handbook for Applicants and Reviewers of Clinical Trials of New Drugs in India. [Internet]. [cited 2023 Dec 17]. Available from: https://main.icmr.nic.in/sites/default/files/reports/Handbook%20for%20Applicants%20and%20Reviewers%20of%20Clinical%20Trials.pdf
Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ. 2012;184(5):533-540. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307558/
Mandrekar JN, Mandrekar SJ. Biostatistics: a toolkit for exploration, validation, and interpretation of clinical data. J Thorac Oncol. 2009;4(12):1447-1449. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2796575/
Clinical Research: Benefits, Risks, and Safety. NIH. [Internet]. [cited 2023 Dec 17]. Available from: https://www.nia.nih.gov/health/clinical-trials-and-studies/clinical-research-benefits-risks-and-safety

Difference between Clinical Trial and Clinical Study

Wed, 01 Nov 2023 10:15:54 GMT

Difference between Clinical Trial and Clinical Study

Summary

Clinical studies and clinical trials are both types of clinical research.
Clinical research aims to study research findings and help translate them in treating patients for various diseases. It comprises different types of clinical studies all of which involve human participation.
Clinical studies are a broader category of research conducted on human participants to study about different diseases and their treatments.
Clinical trials, also known as interventional studies, are a type of clinical study carried out to answer a defined question on the research conducted. It is a specific category which falls under clinical studies.
The difference between these 2 categories is that clinical trials involve investigational medicinal products (IMP) whereas clinical studies do not necessarily involve them. There are also key differences in regulatory requirements of reporting the results of each of them.
It is imperative to know the difference between the 2 categories and a regulatory consultant agency like CliniExperts can help sponsors understand this in order to successfully conduct their clinical research in India.

Introduction

Clinical research is the study of how various medical diseases affect human health. It involves clinical studies which are conducted on people to research about different medical treatments in a more generalised approach. Clinical trials are a type of clinical study where the research is designed to answer a defined question present in a research protocol, involving human participants. In order to successfully navigate between the 2 categories, it is important for sponsors to understand their differences. CliniExperts can help direct them in carrying out their research operations smoothly across India.

Every drug which comes into the market is a result of several years of clinical research conducted on the diseases/medical conditions, treatment methods and ultimately, their respective drugs. This is what clinical research comprises. It is the study of how diseases affect the health of human beings. It aims at directing scientific research to help the treatment of patients by involving participation of people in research.

Clinical research is anchored by clinical studies and there are various types of clinical studies, one of which is called clinical trials. Clinical trials are a major type of clinical studies that are conducted today.

What is a Clinical Study?

Clinical studies involve human participants to help researchers study about different diseases, their respective treatments and the drugs involved in the process. It takes a more generalised approach to help healthcare professionals (HCPs) widen their medical knowledge. It comprises of a wide range of studies such as those involving:

Drugs/ medications
Medical devices
Radiation therapies
Surgery techniques
Diagnostic tools to detect and prevent diseases etc.

There are 2 broad types of clinical studies i.e., interventional studies (also called clinical trials) and observational studies. In interventional studies, researchers test or try out an intervention, such as a drug, device, activity, or procedure, in people and observe its effects on outcomes. Whereas, in observational studies, researchers do not assign participants to a treatment or other intervention; instead, they observe participants or measure certain outcomes to determine health outcomes.

What is a Clinical Trial?

Clinical trials are a type of clinical study where an intervention is introduced to a group of human participants. These trials are conducted to test a potential drug, device, or a medical procedure. They have a preset structure and a set of research protocols/blueprints which must be followed by the participants during the course of the study.

Clinical trials have very detailed and specific purposes such as:

To compare new medical treatments to traditional established treatment methods
To compare an Investigational New Drug (IND) to a control group (placebo) and so on.

Clinical trials consist of 4 phases wherein the studies are successfully conducted to obtain approvals by the regulatory authorities.

The Difference between a Clinical Study and a Clinical Trial:

Both clinical studies and clinical trials come under the broader term, clinical research. According to Good Clinical Practice (GCP), both the terms can be used synonymously. However, when sponsors wish to conduct human participation in clinical research, then the key differences must be understood. They are:

Definition:
- Clinical studies are a broader term which comprises many types of studies such as interventional, observational, epidemiological, cross-sectional, feasibility studies etc. They take a more generalized viewpoint in studying about a particular disease, condition, drug and/or treatment.
- Clinical trials or interventional studies are a subtype or a component of clinical studies which follow a stringent set of study protocols involving human participation who are required to follow specific rules and interventions given in the protocol so as to study a particular drug, disease and/or treatment.

Intervention:
- Clinical studies may or may not involve an intervention such as an IMP or an IND.
- Clinical trials always involve interventions such as an IND. They study how the intervention affects the human population through a set of predefined conditions given in the research protocol.
Legal and Regulatory requirements:

Clinical studies and clinical trials also have different procedures and regulations when it comes to registration and reporting of their respective results.

Type	Clinical trials	Clinical studies
Conduct	Protocol based and GCP compliant	Usual care/clinical practice
Outcome	Efficacy and safety	Effectiveness and economic assessments
Population	Narrow extensive selection criteria	Wide, unrestricted, few exclusions
Comparator	Gold standard/placebo	No comparator/standard care
Randomization and blinding	Yes	No
Relevance	Internal validity	Clinical practice

Table: Differences between clinical trials and clinical studies

How CliniExperts can help?

It is extremely important for sponsors to learn the differences between clinical studies and clinical trials, if they have to conduct them in order to launch their drug and/or treatment in the Indian market.

CliniExperts is a regulatory consultant and a Contract Research Organization (CRO). It is well established within the clinical research framework of India. The regulatory authority governing clinical research in India is the Central Drugs Standard Control Organization (CDSCO). They have stringent regulations for clinical investigations.

Hence, CliniExperts can guide and direct international and local business owners in navigating the complex systems to successfully obtain approval for their clinical trials or clinical studies.

Conclusion

In conclusion, stakeholders involved in either clinical studies or clinical trials must know their differences and similarities, the regulations involved and various other elements. CliniExperts can be of immense help in gaining smooth approvals in order to successfully translate research in treatment of patients.

Reference

https://cliniexperts-research.com/

Best Practices for Designing Medical Device Clinical Investigations

Thu, 21 Sep 2023 12:40:25 GMT

Best Practices for Designing Medical Device Clinical Investigations

What is a clinical investigation of medical devices?

Devices, much like pharmaceuticals, must go through extensive testing processes before gaining approval for use on patients. However, Medical Device Clinical Investigations tend to be more manageable and involve fewer stages compared to pharmaceutical trials. Clinical investigation concerning medical devices involves examining a medical device’s safety and performance on human subjects. This investigation can involve either a completely new medical device or one that is already available on the market in any country.

The primary aim of a clinical investigation is to assess the device’s safety and effectiveness, evaluating its suitability for the intended purpose and target population (as outlined in ISO 14155-1:2020). ISO 14155-1:2020, titled “Clinical Investigation of Medical Devices for Human Subjects – General Requirements,” provides overarching guidelines for conducting clinical investigations. Furthermore, ISO 14155-2:2020 delves into clinical investigation plans, offering detailed guidance.

It is imperative for clinical investigations to adhere to ethical standards governing human subject participation and the scientific principles governing data collection in clinical settings. The clinical investigation plan should comprehensively outline the investigation’s objectives and methodology, ensuring that it aligns with accepted standards and regulations.

What is a medical device?

A medical device encompasses any device that, according to the manufacturer’s definition, is intended for medical use either individually or in conjunction. This category encompasses a wide range of objects, such as equipment, software, materials, or other related items. The designation “medical device” encompasses a variety of products, including breast implants, walking aids, and contact lenses.

All Class III and Class IIb implantable devices in the EU are subject to clinical trials by EU MDR.
The FDA demands clinical investigations for all Class III devices in the US as part of premarket approval (PMA).
In India, Class B, Class C, and Class D risky medical devices are subject to clinical investigation without justification. Class A medical equipment may not require collecting clinical investigation data, with a few exceptions.

Factors to keep in mind while designing the clinical investigation for medical devices:

Sample size: It is often impossible to conduct a clinical study for a medical device involving the target population, particularly if the population size is indefinite. Instead, we conduct research using a sample of the population in the hopes that the data we gather will allow us to conclude the entire population. Therefore, calculating sample size for medical device studies involves figuring out the bare minimum of samples needed to make a study’s outcome or outcomes statistically significant (more reliable in statistics).
Assessment of results for clinical trials on Medical Devices: The clinical trials of medical devices are funded mainly by the industry thus, are prone to report positive responses so that outcomes are in favor of the investigation. Therefore, it is important to report results based on scientific grounds.
Outsourcing the experts: Most medical device manufacturers do not have an in-house Clinical trial team, so they export the team or collaborate with other teams. As a result, there is an increased demand for clinical research organization (CRO) companies. Medical device manufacturers need to see the experience of the CRO before working as if they have experience in medical devices or related field.
Expert team: Manufacturers need an expert team with scientific knowledge to help them design the clinical investigation plan for a medical device.
Regulatory requirements: Besides these points, manufacturers must understand the different regulatory requirements of clinical investigation. After the new medical device regulations, the responsibilities of conducting clinical studies have increased. It is important that all the economic participants, including the producers of medical devices, authorized representatives, importers, and distributors, should have clearly defined interactions with one another.

Five essential Traits for medical device clinical trials:

Five vital traits in medical device clinical trials	Rationale
Low participant enrolment	Endpoints that demonstrate a “reasonable assurance of safety and effectiveness” typically have small sample sizes. Other times, logistical difficulties make carrying out more extensive research impractical.
Blinding	Blinding is one of the most crucial components of clinical trials because it lessens the measurement of bias caused by the partiality of the observer, the doctor, or the patient. Blinding is considered more challenging in randomized clinical trials of medical devices compared to the randomized clinical trials of pharmacological. The medical device manufacturer needs to keep in mind that the outcome of the blind assessment should be planned with trained staff who can assess the outcome.
The design of the trial or procedure can be modified.	In some cases, the trial’s design can be changed based on the feedback received from the researchers or patients. If it can be demonstrated that data from the original device or procedure is appropriate to leverage, validation of the changes may not require a completely new study but additional clinical data beyond the original plan.
Existing data may occasionally completely or partially replace prospective trial data.	The clinical data readily available outside of prospective studies is considered by regulators like the FDA and EU-MDR to assist marketing applications. This is especially important when considering expanded indications for approved devices when there is a body of research supporting the “off-label” use, and it might be challenging or even immoral to assign participants at random.
Numerous device trials evaluate incremental advancements over devices from earlier generations.	While some devices are novel, device development is typically an iterative improvement on current technologies as clinical experience and scientific knowledge increase. Clinical data are frequently needed, though they may not be as extensive as for the original device, to assess the risks and benefits of the new device.

Conclusion

Meticulous planning and adherence to established best practices are essential when designing and executing clinical investigations for medical devices. Several critical factors must be taken into account to guarantee the efficacy and dependability of these trials. Achieving success in medical device clinical trials necessitates thorough planning, unbiased reporting of findings, collaboration with experienced Contract Research Organizations (CROs), the involvement of a proficient team of experts, and strict compliance with regulatory mandates. By adhering to these best practices, manufacturers can validate the safety and efficiency of their medical devices, confirming their appropriateness for their intended purpose and target population.

Role of a CRO in Medical Device Clinical Investigations

Mon, 04 Sep 2023 15:10:18 GMT

Role of a CRO in Medical Device Clinical Investigations

Clinical investigations are essential for assessing the medical device safety and efficacy before they are launched in the market. Regulatory bodies like the CDSCO and CLA oversee clinical investigations in India. CRO for medical device plays a crucial role in conducting clinical investigations offering expertise in study design, regulatory compliance, patient recruitment, and data management. CROs like CliniExperts bring industry knowledge to enhance risk mitigation and cost-effectiveness. Their contributions optimize study processes and yield numerous benefits, ensuring successful and efficient clinical trials.

Clinical research is important to develop new treatments for different diseases in humans. For this, clinical investigations must be performed to assess if a new treatment is safe and effective.

Clinical trials which are performed on medical devices are called clinical investigations and they follow strict research protocols to assess effective treatments for human beings. They follow stringent research protocols in order to protect patients and produce accurate scientific data.

Understanding Medical Device Clinical Investigations

Here are some of the key reasons why a clinical investigation is necessary:

It helps in preventing risks and errors that may happen to patients and healthcare professionals (HCPs).
It helps in establishing the performance of a medical device by checking its technical, functional, and diagnostic abilities, etc.
It helps the manufacturer in achieving the purpose of the device to treat patients.
It verifies the positive clinical benefits by studying patient-focused outcomes.

It is crucial for Contract Research Organizations (CROs) to aid in these investigations as their services are specifically designed to meet medical device clinical trial needs.

The regulatory authorities that supervise clinical investigations in India are the CDSCO and the CLA. Importers/manufacturers who desire to conduct clinic investigations in India must get permission from the CLA by:

Applying through an online identified portal, SUGAM (https://cdscoonline.gov.in/CDSCO/homepage) of the Ministry of Health and Family Welfare (Form MD-22).
The CLA then grants the permission to conduct the investigations through the Form MD-23 (Rule 52 of the Medical Devices Rules, 2017).
The application fee for conducting a pilot clinical investigation is INR 100,000 and that of conducting a clinical performance evaluation is INR 25,000.
The timeline for obtaining permission is 1 to 2 months.

The Value of Partnering with a Contract research organisation (CRO)

A CRO is an organisation that specialises in conducting clinical investigations, and data management. There are many benefits for sponsors and HCPs in hiring a CRO for their clinical investigations as follows:

Expertise in study design and protocol development:
- They have an experienced team of scientists and clinicians who provide expert insights into protocol development and methodology to execute a clinical investigation.
- They create efficient study designs and identify appropriate study designs to generate accurate data while minimizing costs and timelines.
Regulatory compliance and approval:
- CROs are knowledgeable about the latest regulatory requirements of the CDSCO/CLA for conducting clinical investigations.
- They ensure that research protocols are well aligned to comply with these regulatory guidelines so that approvals are achieved seamlessly.
Site selection and management:
- CROs have a vast network and deep databases which help in identifying potential sites to carry out clinical investigations.
- They help in preparing the selected site and the site personnel to conduct the investigation efficiently by following regulatory requirements (site initiation).
- They conduct regular site visits to check for compliance with the protocol, regulatory requirements, and Good Clinical Practice (GCP) (site monitoring).
- Finally, when the study is completed, CROs ensure that all essential documents and study related items are properly collected, stored, and archived (site closeout).
Patient recruitment and retention:
- CROs help sponsors in developing effective patient recruitment as they help in recruiting the required number of patients within the given timeframe due to their wide network and database.
- They also help in retaining patients for the study using various approaches such as making the study as patient centric as possible, providing patients incentives to encourage them to remain in the study, etc.
Data management and analysis:
- CROs have expertise in handling large volumes of data generated during a clinical investigation. They use specialized data management systems to ensure data accuracy, confidentiality, and reporting.
- They conduct verification and quality control processes of clinical data to ensure integrity, accuracy, and reliability.
- They also perform statistical analysis, which is important for interpreting study data, preparing statistical reports, drawing conclusions, and making evidence-based decisions.
Adverse event (AE) reporting and safety monitoring:
- CROs ensure patient safety throughout the investigation. They develop protocols for AE reporting and ensure the site complies with safety precautions.
- They are also prompt in communicating all safety concerns of a trial to the regulatory authorities and other stakeholders.
Project management and timelines:
- CROs ensure that studies progress efficiently, meet the planned objectives and adhere to timelines.
- They achieve this using their expertise in planning, constant communication with all the stakeholders involved, coordination, timely and pro-active problem solving, risk management and resource optimization.
Quality assurance and auditing:
- CROs implement strategies to help maintain data integrity and reliability.
- They also conduct regular external and internal audits to ensure that study sites are adhering to the research protocol.
- They also promptly address any non-compliance issue as and when they arise.

Case studies and Success stories

Successful collaborations between CROs and medical device companies:
- The assistance of CROs in setting up clinical investigations for a sponsor result in faster patient recruitment and regulatory approvals.
Positive outcomes and benefits achieved through CRO partnerships:
- These collaborations lead to streamlined regulatory compliance, faster market entry and cost-effectiveness in the development of medical devices.

Conclusion

In conclusion, CROs like CliniExperts play a pivotal role in clinical investigations of medical devices. Their collaboration with medical device sponsors can lead to innovation and advancement in healthcare, ultimately meaning greater profits for sponsors and healthcare benefits for patients.

References

https://cliniexperts.com/india-regulatory-services/medical-device/permission-to-conduct-clinical-investigation-license-in-india/

From RCT to BCT: How Big Data is Transforming the Clinical Trials Landscape

Wed, 19 Jul 2023 16:02:23 GMT

How big data is transforming the clinical trials landscape

Currently, Randomized Controlled Trial (RCT) is the gold standard of clinical research, but with caveats. Translating biological efficacy into clinical efficacy is a major hurdle. Since RCTs are conducted in strictly monitored environments and even stricter guidelines, their implementation in real-world healthcare situations falls short of desired outcomes. This is true especially for the underserved healthcare ecosystems where lack of infrastructure, facilities, technology, imbalance between trained adequate manpower and patient population, and other factors prevent research outcomes to bear fruit in real-world treatment regimes.

A ray of hope to arrest this inadequacy is Big-Data Clinical Trial or BCT. With its intrinsic advantage of data-guided interventional models, clinicians are now better-equipped to derive accurate and efficient treatments using BCT.

How has big data revolutionized clinical research?

Since data feeds from trial sites are received in real time and their inflow is continuous, researchers are able to construct precise predictive analytics models based on the latest information gathered around vital trial factors such as drug tolerability, drug exposure levels, drug immunity, tolerability, patient safety, treatment outcomes, and other matrixes. The combination of up-to-the-minute data updates, their unquestionable reliability, and their “anytime” accessibility creates an agile research environment in which continuous data modeling as well as continuous data “editing” is made possible, due to which rehashing of analytics is possible on the go as trials progress. Eventually, as trials conclude, such humongous data analyzed on a daily basis creates robust, reliable, and resilient BCT models.

Automation further helps to improve accuracy and effectiveness of analytics, since the human error factor is discounted in BCTs.

Thus, traditional data-dependent clinical trials are rapidly transforming into data-driven activities, thanks mainly to the BCT models. As Associate Director & Head, Emerging Analytics and Advanced Visualizations, Janssen Pharmaceuticals, articulates, “This (BCT) has culminated in sponsors of trials having the unique opportunity to leverage big data and advanced analytics to optimize and improve clinical trials operations at a time when advanced analytics is coming of age.”

The business side of BCT

How does the BCT ecosystem enable businesses to improve their top-lines and bottom-lines?

BCT design and implementation often incorporate other information provided by sponsoring clients, such as biomarkers, claims data, data from wearables and medical devices used on patient population, their medical imaging and electronic records, and the like. This combination of multiple factors facilitates superior trial outcomes, the end-result of which is safer drugs with better efficacy. Good products mean good profits.
BCT programs are cost-effective. Extraction, extrapolation, synthesis, analytics, and reporting of data through manual processes is often costlier than the automated versions.
BCT models ease the pain of patient recruitment and reduce their dropout rates, hence improving results and enabling companies to produce drugs with better efficacy on a wider section of real-world patients.
BCT not only streamlines the entire trial process but also reduces trial time, thus eliminating delays.
These trials reduce the go-to market time of end-products.
And of course, ready-to-serve big data analytics are availed faster with BCT.

Additional benefits of big data in clinical trials

Aside from research and trials, big data has also helped in improving post-trial value chains, and made it easier for clinicians to treat patients. Be it medical infrastructure, healthcare professionals and frontline workers, logistics, supply chain, delivery, or availability, big data has produced positive results across the healthcare pipeline.

How effective is BCT in healthcare decision-making? We get an inkling from the fact that COVAX succeeded in delivering 1 billion vaccines to 144 participating countries by January 2022, thus making the vaccination drive equitable and inclusive with the help of big data.

Human longevity has increased from 66.8 years in 2000 to 73.4 in 2019. However, healthy life expectancy remains at 63.7 years. As we live longer, we are predicted to fall sick often and face many new health threats during our lifespan. Amidst this classic paradox, big data and BCT have emerged as the sunrise factors in clinical trials and healthcare domains.

The Drug Development Process – From Conception to Market · Cliniexperts

Tue, 02 Aug 2022 18:06:20 GMT

The Drug Development Process –From Conception to Market

Drug development encompasses the entire process of bringing a new drug to market. The drug discovery journey starts with the identification of a disease or disease area with an unmet medical need and ends with regulatory submissions and market launch.

This article explores the process of drug development from discovery through the stages of development up to approval and product launch.

Stage 1: Early drug discovery program

Companies start with the pre-discovery phase by uncovering the molecular basis of the disease. Researchers study the mechanisms at the tissue and subcellular levels. Based on the underlying disease mechanism, suitable animal disease models and assay platforms are developed.

The next step is target identification. A “target” is an entity (gene/protein) whose chemical modulation may lead to a desired therapeutic effect. Target validation is the process of demonstrating the relevance of the selected target for a specific biological pathway, process or disease.

After target identification and validation, follows the hit identification and lead discovery phase. Hits are molecules that can bind to the target and modify its function. Some of the screening methods available to identify hit molecules include high throughput screening, focused or knowledge-based screening, fragment screening, virtual screen and physiological screen.

During lead discovery, an in-depth search results in the identification of a drug candidate that is progressed through preclinical studies, and if successful, into clinical development and ultimately launched in the market.

Stage 2: Preclinical Research

Preclinical research involves all activities that link drug discovery in the lab to the initiation of trials inhumans. The ultimate goal of preclinical phase is to predict the biological effect of a drug accurately.

Preclinical studies are required by all the regulatory authorities. Preclinical phase helps predict the treatment outcome and identify and characterise all toxicities associated with the drug. Pharmacology studies to evaluate the pharmacokinetics and pharmacodynamics studies to assess the mechanisms of action of the drugs on the body are also conducted. Preclinical studies are conducted using in-vitro/in-vivo models, animal models or in-silico model.

Stage 3: Preparing for Regulatory approval

An investigational new drug (IND) is defined as a new substance, chemical or biological entity that has not been approved by any regulatory authorities for marketing as a drug in any country. An investigational drug is often known as a “study drug” or “experimental drug”.

In India, the approval of manufacture/import of Investigational New Drugs for marketing in the country is given by the Central Licensing Authority (CLA).Permission to conduct clinical trials of new drugs, including Investigational New Drugs, is also provided by CLA.The IND application must ideally contain information in three broad areas:⎯Animal Pharmacology and Toxicology Studies⎯Manufacturing Information⎯Clinical Protocols and Investigator Information

Stage 4: Clinical Trials

The efficacy, safety, dosing, and tolerability of new drug molecules is established through carefully designed and executed clinical trials. Clinical trial for a new drug progresses through a series of steps called phases during which vital information regarding the new drug is generated.

Clinical trials of drugs developed in India have to undergo all four phases of trials.

⎯Phase I or “first in man” study

-Phase I trials evaluate the safety and tolerability profile of an investigational new drug in humans. Phase I trials are conducted in healthy subjects or specific groups of patients.

⎯Phase II or exploratory trials

-Phase II trials evaluate the drug’s effectiveness for a particular disease/condition in patients. This phase help identify the common short-term side-effects and other risks associated with the drug. The dose and regimen of the drug for Phase III trials are also decided.

⎯Phase III or confirmatory trials

-Phase III or confirmatory trials confirms the drug safety and efficacy in a larger number of patients, usually between 1000-3000 subjects. In phase III, the drug may be compared with a standard drug and/or a placebo. If the phase III trial results are favourable, the data is presented to the regulatory authorities for a commercial license to market the drug.

⎯Phase IV or post-marketing trial

-Phase IV or post-marketing trial of new drugs are performed after the drug’s approval.

Stage 5: New Drug Application

-New Drug Application (NDA) is an application made by the sponsor to the regulatory authorities for approval to sell and market a new drug in different countries.

NDA includes enough information for the regulatory authorities to determine whether the new drug is safe and effective, whether the drug’s benefits outweigh its risks, whether the proposed drug label (package insert) is appropriate, and whether the drug manufacturing standards are adequate.

NDA can be broadly divided into different steps:

⎯ The submission of application to conduct clinical trials

⎯ Conducting clinical trial

⎯ Application to marketing authorisation of drug by submitting the data collected from the clinical trials

⎯ Post-marketing surveillance

Stage 6: Product Launch

Once the drug receives approval from the licensing authority, several activities are initiated to prepare for the product’s market launch. Some of the key activities during this stage include:

⎯ Production and scale-up activities

⎯ Packaging and labelling activities

⎯ Storage and distribution

⎯ Developing market access strategies

Stage 7: Post-marketing Safety Surveillance

Post-marketing safety surveillance is the identification and collection of information regarding the drug product after its approval.Periodic safety update reports (PSUR) are pharmacovigilance documents that allow regular assessment of the drug product’s risk-benefit balance after it is marketed. The primary purpose of the PSUR is to identify new or emerging safety information as a means of determining changes in the benefit-risk profile of the authorised drug.As per the New Drugs and Clinical Trials Rules, 2019, the companies should furnish PSURs every six months for the first two years after drug approval. For the subsequent two years, the PSURs need to be submitted annually.

References

Bermúdez-Crespo J, López JL. A better understanding of molecular mechanisms underlying human disease.Proteomics Clin Appl. 2007;1(9):983-1003.
Schenone M, Dančík V, Wagner BK, Clemons PA. Target identification and mechanism of action in chemical biology and drug discovery.Nat Chem Biol. 2013;9(4):232-240.
Targum SD, Milbauer AJ. The process of getting new drugs to market.Psychiatry (Edgmont). 2008;5(8):57-60.
Polson AG, Fuji RN. The successes and limitations of preclinical studies in predicting the pharmacodynamics and safety of cell-surface-targeted biological agents in patients.Br J Pharmacol. 2012;166(5):1600-1602.
Hughes JP, Rees S, Kalindjian SB, Philpott KL. Principles of early drug discovery.Br J Pharmacol. 2011;162(6):1239-1249.
Saxena P, Saxena R. Clinical trials: changing regulations in India.Indian J Community Med. 2014;39(4):197-202.
New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

Covid-19 vaccines approved for use in India – What you need to know · Cliniexperts

Tue, 02 Aug 2022 18:03:38 GMT

Covid-19 vaccines approved for use in India – What you need to know

Indian, one of the leaders in the pharmaceutical sector, is set to play a vital role in the global COVID-19 vaccination effort.On 03 January 2021, the Drugs Controller General of India (DCGI) granted emergency approval for two COVID-19 vaccines –Covishield and Covaxin. Both Covishield and Covaxin work by triggering the immune system against the spike protein of the SARS-CoV-2 virus (novel coronavirus). While Covaxin uses an inactivated SARS-CoV-2 virus, Covishield includes a weakened version of adenovirus.

Bharat Biotech’s Covaxin

Covaxin is the first COVID-19 vaccine made in India. The vaccine is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology.

Covaxin is a whole virion inactivated vaccine made up of killed coronaviruses, making it safe to be injected into the body. When the vaccine is administered, the dead virus can trigger the immune system to produce antibodies against the novel virus. As per the National Institute of Virology, antibodies induced by Covaxin can neutralise the UK variant strains as well. Covaxin is given in two doses, four weeks apart.

Covaxin was studied in preclinical studies in mice, rats, rabbits and Syrian hamster. Challenge studies on on-human primate models have also been carried out. Phase I and Phase II clinical trials showed that the vaccine is safe and demonstrates a robust immune response.

The efficacy, safety, and immunogenicity of Covaxinare being studied in a phase III trial in 25,800 subjects aged ≥18 years. The study population also include subjects aged above 60 years of age (2400 subjects) and subjects with comorbidities (more than 4500 subjects).

As per the interim analysis of the phase III trial, Covaxindemonstrated 81% efficacy in preventing COVID-19 in those without prior infection after the second dose. The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus seven cases observed in the Covaxin group.

Covishield

Covishield is the Indian version of the Oxford -AstraZeneca COVID-19 vaccine (AZD1222). The Serum Institute of India manufactures Covishield.

Covishield consists of a replication-deficient chimpanzee adenoviral vector, ChAdOx1, containing the SARS-CoV-2 spike protein gene. Covishield is given in two doses, four and 12 weeks apart.

The interim analysis of Covishield, published in Lancet in December 2020, reports that the vaccine has an efficacy rate of 70.4% and possesses an acceptable safety profile. The efficacy results are based on a pre-specified pooled analysis of phase III trials in the UK and Brazil.

Based on the interim safety and immunogenicity data from the overseas clinical studies, the Indian regulators granted approval for the Phase II/III clinical trial of Covishield on an Indian cohort. The study on the Indian population was initiated in November 2020 and has enrolled 1600 people at 15 different centres across the country.

Vaccine candidates in development

Apart from Covaxin and Covishield, several other vaccines are at different stages of clinical development:

COMPANY	VACCINE	CURRENT STATUS
Cadila Healthcare Ltd	ZyCov-D -Plasmid DNA vaccine	Received DCGI approval for conducting phase III trial
Biological E in collaboration with US-based Dynavax and Baylor College of Medicine	COVID-19 subunit vaccine candidate. CpG 1018 used as adjuvant	Phase I/II trials ongoing
Genova biopharmaceuticals in collaboration with Seattle-based HDT Biotech Corporation	HGCO19 -mRNA vaccine	Received DCGI approval for conducting phase I/II trial
Bharat BioTech	BBV154 -Novel adenovirus vectored, intranasal vaccine	Received DCGI permission forPhase Itrials
Dr Reddy’s Lab and Gamaleya National Centre in Russia	Sputnik V	Phase II/III clinical trials ongoing in Indian population. Interim results from the phase III trial in Russia showed an efficacy rate of 91.6%.
Serum Institute of India and American vaccine development company Novavax	COVOVAX-recombinant protein-based vaccine	Applied to initiate the bridging trial in India.Was found to be 89.3% effective in a UK trial.

India’s mega immunisation drive

The pandemic can be controlled only if the approval, production, and distribution of the vaccines go smoothly and vaccines are administered to the people, especially those vulnerable.

India’s mega immunisation drive started on 16 January 2021. Nearly 30 million people were vaccinated in the first phase; healthcare and frontline workers were given priority. In the second phase, people over 60 and those between 45 and 59 with comorbidities are getting vaccinated. From 01 April 2021, all above 45 can get vaccinated.

India is reported to make 60% of the world’s vaccines and plays a major role in the global vaccination drive. India is also providing vaccine to neighbouring countries. As of 25 March 2021, India has shipped 604.49 lakh doses of vaccines to 76 countries.

References

COVAXIN® -India’s First Indigenous COVID-19 Vaccine. Available at: https://www.bharatbiotech.com/covaxin.html. Accessed: 25 March 2021.
Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency approval of COVID-19 virus vaccine. Available at: https://pib.gov.in/PressReleseDetail.aspx?PRID=1685761Accessed: 25 March 2021.
Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK [published correction appears in Lancet. 2021 Jan 9;397(10269):98].Lancet. 2021;397(10269):99-111.
Logunov DY, Dolzhikova IV, Shcheblyakov DV, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologousprime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia [published correction appears in Lancet. 2021 Feb 20;397(10275):670].Lancet. 2021;397(10275):671-681. doi:10.1016/S0140-6736(21)00234-8
Harrison EA, Wu JW. Vaccine confidence in the time of COVID-19.Eur J Epidemiol. 2020;35(4):325-330.
Bharat Biotech Announces Phase 3 Results of COVAXIN. Available at: https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf. Accessed: 25 March 2021.7.Vaccine Supply. Ministry of external affairs. https://www.mea.gov.in/vaccine-supply.htm

Are Investigational New Drug Trials in India A Positive Sign For Healthcare · Cliniexperts

Tue, 02 Aug 2022 18:01:27 GMT

Are Investigational New Drug Trials in India A Positive Sign For Healthcare

On June 1st, 2021, the Indian Government announced the waiver of requiring prior India bridging clinical trials to be conducted for the US and UK-based vaccines for the novel COVID-19. This move comes in the midst of immense pressure faced by the Government due to the shortage of vaccines, where a huge section of the Indian population, including the youth, are left vulnerable. As this news brought a wave of relief among the general public, it also has caught the attention of Indian epidemiologists, regulators, researchers, and clinicians.

The move was applauded by the professionals in the closed groups of clinical trials management India has, as the decision would promote the efficiency of the healthcare system in the better interest of the general public, as well as frontline workers who are overwhelmed in the second wave of the grueling pandemic.
However, two members of the National Institute of Medical Statistics, ICMR, Delhi have spoken about the scientific considerations of such a groundbreaking decision.

What are the grounds for such a waiver?

For the waiver of vaccine clinical trials in India to be considered, the trial must be found in the global pool of the International Clinical Trial Registry Platform by WHO, and the trial for such a drug must be registered in a clinical trial registry of the country of origin. Furthermore, there must be an elaborate disclosure of such drug trial results on the registry to consider the waiver. The waiver of vaccines and drugs may not be processed depending upon its permissibility in scientifically advanced nations like the USA. The priority lies on the level of scientific and research methodology, which should have parameters that take into consideration not just a particular section of the population, but also the global effects of consumption.

Being mentioned on the clinical trial registry vouches, the clinical trial management registry of India has access to all the data collected by WHO’s International Clinical Trials Registry Platform (IRCTP) database regarding Pfizer and Moderna vaccines. These points pertain to the research model, randomization allocation concealment, sample size, and the approval of the ethics committee along with the particulars of regulatory clearances. It makes a vaccine or drug credible scientifically since it has passed all the checkpoints and standards set by the WHO and national clinical trial body.

Do Clinicians and Researchers Have any Concerns Regarding Such Waivers?

There are a few concerns that were addressed by these professionals, stating that the drug bypassing the bridge trials in India may show some adverse effects on the Indian masses. There could be a possibility of the racial and genetic variations being a cause of both short and long-term adverse side effects of such vaccines and drugs widely approved by the WHO. In such instances where the probability cannot be ruled out, an opinion of the scientific committee before granting such waivers is necessary.

In the instance of the current case of India, the Central Drugs Standard Control Organization (CDSCO) is the body that heads clinical trial inspections, oversight, and approvals, while the Drug Controller General of India (DGCI) regulates CDSCO as per the 2019-CT Rules. The aforementioned authorities giving their approval for the importation of COVID-19 vaccines in India indicates that such considerations towards adverse side effects of the drugs on the Indian population have been scrutinized prior to the sanction of the waiver. Additionally, the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) made the recommendation of assessing the first hundred recipients of such emergency approved vaccines before it is given the nod for nationwide distribution, which has also been accepted by the Centre, guaranteeing that there are no angles overlooked.

Conclusion: Are There Trials that Do Not Qualify for Such Waivers?

As invigorating as the news has made the country and its citizens, there arises the question of such waivers being bestowed upon other lifesaving drugs that are still subject to strict protocol and scrutiny. However, drugs for diseases like cancer, H1N1, and HIV, trials do not qualify for the waiver. Drugs of such conditions that have proven evidence for their efficacy can be considered to be put through fast-tracked clinical trials. However, this requires extensive epidemiological as well as statistical research along with clinical parameters. The COVID-19 vaccine waiver may open doors to the possibility of other emergency drugs improving their research for global distribution, which gives us hope for the future, post-pandemic.

Phase 2-3 Clinical Trials for Covaxin To Commence On Children Aged 2-18 Years Soon · Cliniexperts

Tue, 02 Aug 2022 18:00:31 GMT

Phase 2-3 Clinical Trials for Covaxin To Commence On Children Aged 2-18 Years Soon

On the 13th of May, 2021, as per one of the country’s top health officials, India’s very first trial of a domestically manufactured Covid-19 vaccine is all set to commence on children in the next 10-12 days. At the forefront of global concerns lies the fear that the next wave of the pandemic may strike the country hard if the citizens are not given preliminary safety measures such as the vaccine.

Bharat Biotech, the maker of Covaxin, had proposed to conduct Phase II and Phase III clinical trials of their COVID-19 vaccine for children belonging to the age group of 2 to 18 years. This trial is going to be administered to 525 healthy volunteers. However, the news was met with high levels of apprehension and resistance by the public.

On Tuesday, the Government of India said that trials pertaining to Covaxin’s efficacy against the SARS-COV-2 virus and its variants on children of ages 2-18 years aim to have all citizens vaccinated by the end of 2021, making over 200 Crore doses available from August to December. Addressing a Health Ministry briefing, Niti Aayog member VK Paul provided his statement on the matter by saying, “Covaxin has been approved by the Drugs Controller General of India (DCGI) for phase II and III clinical trials in the age group of 2 to 18 years.”

India’s drug regulator DCGI accepted the recommendation of the Subject Expert Committee (SEC) and approved the Hyderabad-based Bharat Biotech to commence their Phase II/III clinical trials on the 13th of May. Covaxin by Bharat Biotech is backed by the Indian Council of Medical Research (ICMR) and is effective so far against the majority of the new variants of the virus that have unleashed immeasurable damage in India during the second wave.

The clinical trials phase II and III for Covaxin consist of two Covid-19 vaccine shots injected to the volunteers on days 0 and 28, respectively. The data of the efficacy and any side effects shall be recorded by the company and ICMR to arrive at a conclusive report.
These trials will be hosted at various sites, such as AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.

The announcement for the approval of trials on children came as a shock amidst reports of new COVID-19 strains affecting an alarmingly growing number of children. Earlier this week, the Chief Minister of Delhi, Mr Arvind Kejriwal, made an appeal to the Central Government for the immediate cancellation of all airway services embarking from and to Singapore, claiming the new strain of Coronavirus detected there is “highly dangerous” to children. This new variant could capsize India in the third wave, he said on his social media account.

Among others who have raised their concerns for the safety of the children undergoing trials, a bench of Chief Justice DN Patel and Justice Jyoti Singh issued notice on a Public Interest Litigation (PIL) filed by Sanjeev Kumar. This notice seeks direction to stay the order passed on the 13th of May, which gave Bharat Biotech the consent for conducting clinical trials on children between the ages of 2-18 years. The Ministry of Women and Child Development, too, was delegated as a party to these proceedings.

In a subsequent hearing, the Delhi High Court on Wednesday, the 19th of May, denied an interim stay order on the clinical trials of Covaxin on the children volunteering. However, the court has also sent out notices to the Drugs Controller General of India (DCGI) and other parties involved with a plea challenging the DCGI’s approval to Bharat Biotech for conducting these trials. Further developments are awaited in the matter, given the citizens’ nervousness to subject children to the Coronavirus vaccine clinical trial in India, especially with several noted side-effects found in adults.

Besides Covaxin, the vaccine producer Serum Institute’s Covishield is also being utilized to vaccinate citizens in India. In the meantime, Russia’s Sputnik V is also being made available for beneficiaries who are 45 years or older at Apollo Hospital at Hyderabad’s Jubilee Hills. Small to medium level hospitals in Mumbai, too, could begin administering Sputnik V vaccines from the month of June.

COVID-19 – Can patent waivers increase vaccine coverage? · Cliniexperts

Tue, 02 Aug 2022 17:59:33 GMT

COVID-19 – Can Patent Waivers Increase Vaccine Coverage?

With the new virus variant causing a surge in infections, India has been crippled by the pandemic. Apart from the shortage of medicines, oxygen and healthcare staff, several states in India face a shortage of vaccines – one of the most effective tools to end the pandemic.

As of 5 May 2021, 1.1 billion COVID-19 vaccine doses have been administered. However, only 0.3% went to low-income countries. Experts predict that if the vaccine production and distribution are not ramped up, it may take a minimum of 2 years for most income countries to be vaccinated.

In October last year, around 100 countries, led by India and South Africa, requested World Trade Organization members to agree on a time-limited waiver of COVID-19-related intellectual property (IP) rights. As per the request, the vaccine suppliers should share their knowledge so that more countries, especially low-income countries, can start producing vaccines on their own. Waiving the IP is expected to increase the production and the global coverage of COVID-19 vaccines.

US support to waive patents on COVID-19 vaccines

The US until now had opposed the plan to waive the IP related to COVID -19 vaccines, but in a dramatic turn of events, on 5 May 2021, the US trade representative, Katherine Tai, announced that the US would support a proposal to waive patents on COVID-19 vaccines considering the urgent need for more global supply.

The pharmaceutical industry and others have opposed the decision to lift patent protections on COVID-19 vaccines. The opponents argue that waiving patents on COVID-19 vaccines may not ramp up production quickly and could compromise vaccine quality. However, supporters of the waiver disagree and point out that generics drug developers have been supplying the world with high-quality vaccines and drug products for years.

What does the COVID-19 patent waiver mean for India?

Experts suggest that there is a high probability of a third wave of the pandemic in India. Developing affordable generic vaccines can increase vaccine accessibility and help the country prepare for the next surge. If the patents are lifted, it will undoubtedly mean expanding the scale of production and speeding vaccine rollout.

Manufacturing vaccines can be challenging

Manufacturing vaccines is a complex process and is easier said than done.
Though the IP waiver may be game-changing, many experts believe that IP is not the real hurdle. Manufacturers in developing countries need to be supported with the technology to actually produce the vaccines. This applies particularly to innovative vaccines such as mRNA. A majority of the COVID-19 vaccines involve an element of genetic manipulation, a highly complex procedure, which may be difficult to reverse engineer.

Manufacturing equipment and raw materials are other bottlenecks. It also requires highly trained staff and the establishment of workflows with stringent quality control.

While the US has proposed to support patent waiver, the export of vital raw materials is still blocked as per the country’s Defense Production Act, which grants US vaccine makers priority access to specialised materials such as filters, tubing and specialised disposable bags essential to making vaccines.

Lastly, any vaccine which is manufactured will have to go through the final step of clinical trials to get regulatory approvals.

Reverse-engineered COVID-19 vaccines will undoubtedly have to go through clinical trials

Vaccine manufacturers who reverse engineer COVID-19 vaccines will have to run the vaccines through clinical trials once again. Clinical trials are necessary to evaluate the reverse-engineered version’s immunogenicity and efficacy.

CliniExperts – Clinical trial services tailored to individual needs

Sharing of technology and IP could increase global vaccine coverage, which would likely increase public and private investment in developing countries like India.

At CliniExperts, we understand the difficulties of conducting clinical trials and the strategies that enable hassle-free launches. CliniExperts brings you innovative clinical trial solutions based on the latest technology.

We offer a wide range of clinical trial services and have the ability to handle challenges and complications in any clinical trial. Our services are specifically tailored to ease the process of getting your products ready for the market.

References

It’s time to consider a patent reprieve for COVID vaccines. Nature. 2021. Available at: https://www.nature.com/articles/d41586-021-00863-w. Accessed: 21May2021.
In shock move, US backs waiving patents on COVID vaccines. . Nature. 2021. Available at: https://www.nature.com/articles/d41586-021-01224-3. Accessed: 21May2021.
Covid-19 vaccine inequity: the debate over patent waivers intensifies. Pharmaceutical Technology. 2021. Available at: https://www.pharmaceutical-technology.com/features/covid-19-vaccine-inequity-patent-waivers/. Accessed: 21May2021.
Iacobucci G. Covid-19: How will a waiver on vaccine patents affect global supply?. BMJ. 2021;373:n1182.

Effective Site Management in Clinical Research – Points to Consider · Cliniexperts

Tue, 02 Aug 2022 17:58:30 GMT

Effective Site Management in Clinical Research – Points to Consider

Clinical trials are essential to deliver new therapies and advance medical knowledge and patient care. A key aspect of a successful clinical trial is the efficient management of clinical sites.

Site management in clinical research

Efficient site management is essential to ensure that the clinical study runs smoothly and results in the best outcome. Selecting sites as per the study protocol and the applicable regulatory requirements can positively impact the quality of data collected and ensure that the study is conducted as per the agreed timelines and within the budgets.

Site management activities

Site management in clinical research involves effective site monitoring and constant communication between the various stakeholders throughout all phases of the clinical study – study start-up, study conduct, and study closure. A CRA or Site Manager is responsible for ensuring efficient site management in various clinical study projects.

Site management activities followed before study start-up:

Management and review of clinical trial feasibility
Site qualifications – Site selection and pre-study visits
Selection of study investigator
Contract and budget execution
Vendors approval and setup

Site management activities at the time of study start-up:

Oversee start-up
Site activation, site initiation visits
Set recruitment expectations
Ensuring training

Site management activities during the enrolment period:

Facilitation and review of enrolment
Ensuring regulatory compliance and adherence to the protocol
Management of adverse event reporting
Study document review and query resolution
Study monitoring – Remote and on-site
Data collection

Site management activities during study close-out:

Ensuring protocol adherence
Addressing data queries
Ensuring final source data verification of study documents
Managing the collection of final safety data
Review and accountability of all study drug
Assessment and collection of all relevant regulatory documents
Ensure audit readiness
Ensure record retention requirements

Why is site management important?

Efficient clinical site management is essential for the smooth execution of clinical trials to ensure the optimal trial outcome. Proper site management enables sites to effectively recruit and retain subjects while adhering to the study protocol and relevant regulatory guidelines.

The key to strong collaboration with the sites is ensuring proper site management throughout all phases of a trial. Strong collaboration ensures increased efficiency, consistent communication, adherence to regulations and improved data quality.

CliniExperts – Clinical site management services

CliniExperts has an exceptional track record in clinical site management that ensures scientific excellence and data integrity across all sites. We engage highly competent clinical research associates to perform all aspects of site management throughout the study. Our team of experts exercise ultimate efficiency in managing investigator sites and focus on ensuring adherence to data quality, subject safety, and early issue resolution throughout the trial. Our experts oversee data collection, review source documentation and case report forms, ensure regulatory compliance and resolve data queries. We also conduct interim analyses as requested by the client.

As part of our site management services, we also support the training of site staff to meet industry compliance standards and ensure that the site and the staff are adequately prepared for audits and inspections.

Critical to a successful clinical trial is ensuring proper site management during all phases of a trial. Efficient site management ensures scientific excellence and data integrity across all sites.

References

Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11:78.
Study Management. The University of Texas Health Science Center. Available at:https://www.uth.edu/ctrc/trial-conduct/study-management.htm. Accessed: 21 May 2021.

Biosimilars in India – Things you need to know · Cliniexperts

Tue, 02 Aug 2022 17:57:12 GMT

Biosimilars in India – Things you need to know

Biological agents show significant clinical benefits, but their high cost limits their accessibility. The demand for cost-effective options and the patent expiry of biologics have propelled the development of biosimilars or similar biologics.

This article covers the key takeaways from the Indian regulatory guidelines for the approval of similar biologics in India.

Guidelines for similar biologics in India

The guideline for similar biologics in India was released in 2016 by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT).

The 2016 guideline are an update to previous guidelines published in 2012. The authorities revised the guidelines to provide a clear regulatory pathway at par with international regulations for the approval of similar biologics in India.

As per the guideline, a similar biologic product is that which is similar in terms of quality, safety and efficacy to an approved reference biological product based on comparability.

The guideline enumerates the various regulatory requirements for the manufacturing, preclinical studies, clinical studies and post-marketing requirements for similar biologics.

The approval of similar biologics follows a sequential process and involves the following authorities:

Institutional Biosafety Committees
Review Committee on Genetic Manipulation (RCGM)
Genetic Engineering Advisory Committee
CDSCO

Reference biologic

A product can only be considered similar biologic if proven similar using extensive quality characterization against the reference biologic. The dose, strength, dosage form and mode of administration of similar biologics need to be similar to that of the reference product.

Companies planning to develop similar biologics are required to submit the rationale for selecting the reference product to the regulatory authorities. The reference product should have been approved in India using a complete data package. When the reference product is not authorized in India, it should be approved/licensed and marketed in an ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) country.

Requirements for manufacturing and characterization studies

Similar biologics should be manufactured following good manufacturing practices. The manufacturing process should be robust, consistent and reproducible.

Companies need to provide a complete description of the manufacturing process, including details regarding the host cell cultures, vectors and gene sequence. The post-translational modifications, if any, should also be enumerated.

Data for submission should include:

A complete description of the drug product and the associated processes
Critical and vital quality features of the product
Manufacturing process controls
Variables affecting the production process (Critical process parameters)
Data from stability studies
Comparability of product manufactured at clinical scale against reference biologic
Data from consistency batches and/or process validation batches as applicable

Analytic characterization is required to demonstrate similarity between the similar biologic and the reference drug. Indian guidelines recommend characterization studies to evaluate immunological and biological activities, physical/chemical properties, content, purity, contamination and content.

Real-time stability studies, accelerated studies, and stress studies should be conducted to evaluate the product’s shelf life, storage conditions, and degradation profile.

Variability between the similar biologic and the reference product should be evaluated to assess the potential impact on the safety and efficacy of similar biologic. Additional characterization studies may be necessary in such cases.

Conducting preclinical and clinical studies

Once the analytical studies characterize the similarity between similar biologic and the reference product, companies need to conduct preclinical and clinical studies to test the safety and efficacy of the similar biologic.

Comparative pharmacokinetic (PK)/ pharmacodynamics (PD) studies are required to establish similarities in PK/PD characteristics between the similar biologic and the reference product. The type may vary case by case – Drug developers can combine PD and PK studies, or PD study can also be conducted together with phase III studies as appropriate.

A phase III comparative clinical trial is required to establish the similarity in efficacy and safety between the similar biologic candidate and the reference product. In recombinant human-soluble insulin products, only a comparative safety study is required.

Equivalence or non-inferiority studies may also need to be conducted. Before study initiation, the manufacturer must consult the CDSCO and justify the rationale for the sample size estimation and define the comparability limits.

The confirmatory safety and efficacy study can be waived if the similar biologic demonstrates high similarity with the reference biologic regarding the structural and functional characteristics, preclinical and PK/PD outcomes. However, confirmatory phase 3 clinical studies cannot be waived for large molecular weight biologics like monoclonal antibodies.

To ensure the absence of any unexpected safety concerns, clinical studies to evaluate the immunogenicity and adverse events are mandatory. The immunogenicity profile of the similar biologic should be compared to the reference biologic. Pre-approval comparative safety data should be based on adequate patient exposure and presented along with published data on the reference biologic.

When can extrapolation of indication be considered?

Extrapolation of indication can be considered if similarity has been established between the similar biologic and the reference product with respect to the quality or preclinical assessment. Additionally, demonstration of efficacy and safety in one indication allows extrapolation for other indications if the exact mechanism of action or receptor is involved. It should be noted that new indications that are not specified by the innovator require a separate application.

References

Department of Biotechnology and Central Drugs Standard Control Organization. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India,2016. Available from: http://dbtindia.gov.in/sites/default/files/uploadfiles/Guidelines_on_Similar_Biologics%2C201 6.pdf . Accessed: 18April 2021.

Conducting clinical trial during COVID-19 · Cliniexperts

Tue, 02 Aug 2022 17:55:44 GMT

Conducting Clinical Trial during COVID-19

COVID-19 has caused a massive shift in how we manage clinical trials. Due to inadequate resources and restrictions placed due to the pandemic, companies are struggling to maintain the safety of study participants and staff while ensuring the continuity of ongoing trials.

The pandemic also paved the way for new trials as experts tried to understand the virus and its impact and test prospective drug candidates. Of the 60 trials approved by Central Drugs Standard Control Organisation (CDSCO) in September and October 2020, around 25% were Covid-19 studies.

The Indian Society for Clinical Research (ISCR) has laid down guidelines for the conduct of clinical trials during the COVID-19 pandemic. The guidance emphasises ensuring the safety of trial participants irrespective of the challenges. This article covers the key takeaways from the ISCR guidelines.

Face-to-face visits may be converted to telephonic visits

Study visits for ongoing trials may be postponed or converted to telephonic visits. Before making a decision, investigators should assess the risk-benefit ratio for each scenario – trial integrity should be maintained in each case.

The Sponsor can provide a generic notification for the approach it intends to take for the studies conducted at a given site. Once the decision is made, it can be communicated upon request by CDSCO, ethics committee/ Sponsor.

Suspension of ongoing recruitment for trials and temporary halt of the ongoing trials

The recruitment and treatment of patients may be discontinued entirely by the investigator to ensure patient safety during the pandemic. This applies especially to trials that are time-bound and protocol-driven. The decision and rationale for the approach need to be communicated to the ethics committee, Sponsor and CDSCO.

Sponsors and clinical investigators are encouraged to engage with IRBs/IEC as early as possible if significant amendments to the protocol or informed consent are expected. To avoid immediate hazards and safeguard patient’s health, the investigator can implement urgent changes to the protocol or investigational plan without IRB approval. However, these changes need to be mandatorily reported to the IRB later.

Accountability for missing information

Changes to study conduct (missed samples, altered visits and patient discontinuation) due to the pandemic may lead to missing information. Such missing data should be captured appropriately in the source documents and the case report form. The reason for the deviation should be mentioned, and the COVID-19 relationship should be explained. When included in the clinical study report, this information can be vital to the Sponsor and CDSCO.

Protocol amendments regarding efficacy assessments such as delays in assessments, use of virtual assessments and alternative collection of specimens should be notified to the ethics committee.

Clinical trial supplies and biological sample

To minimize trial site visits, patients be provided with adequate clinical supply. An uninterrupted supply of the investigational product, such as distributing the investigational products directly to the patient (DTP), is one example. The DTP should be initiated only when there are no alternate options to maintain dosing. Following are the scenarios that can be utilized before requesting DTP.

Utilize the dosing windows to adjust visits without deviating from the protocol scheduled visits
See if a caregiver can pick up the investigational medicinal products (IMP)/Non-IMP from the site
Check if the site is willing to allow the hospital’s pharmacy to be the place where the IMP/non-IMP can be picked up if the clinical trial site is shut down or patients are not allowed in the hospital

While following DTP, it is mandatory to follow and document IMP accountability as per the applicable regulations.

Other than the DTP, there may be a need to conduct laboratory testing at local labs for safety monitoring. This needs to be recorded remotely by the investigator and discussed and agreed upon with the Sponsor.

Screening and recruitment of new clinical trial participants

Hospitals that have restricted clinical trial participants from visiting the facility due to safety concerns must immediately inform the temporary closure of the site facility to the Sponsor, IEC / IRB.

Routine screening of new clinical trial participants is not be prohibited by CDSCO. Risk/benefit assessment needs to be done by the investigator before conducting new screenings.

References

Guidance for the Management of Clinical Trial Activities in response to COVID-19 Pandemic Recommendations from ISCR. Available at: https://www.iscr.org/wp- content/uploads/2020/06/Guidance-for-the-Management-of-Clinical-Trial-Activities-in- response-to-COVID-19-Pandemic_INDIA_FINAL-002-min.pdf . Accessed: 18 April 2021
Perez T, Perez RL, Roman J. Conducting Clinical Research in the Era of Covid-19. Am J Med Sci. 2020;360(3):213-215.

Online submission of SAE reports through SUGAM portal · Cliniexperts

Tue, 02 Aug 2022 17:52:25 GMT

Online submission of SAE reports through SUGAM portal

The New drugs and clinical trials rules, 2019, requires that the investigator, sponsor / CT-NOC holder and ethics committee report all serious adverse events (SAE’s) to the Central Licensing Authority (CLA) within a specified time-frame. CDSCO, through the SUGAM portal, started the process of electronic submissions of clinical trial applications. Electronic submissions make the submission process hassle-free. It also enables the easy tracking of applications. The latest development in the space of e-governance is the launch of a software for the online submission of SAE reports. On February 25, 2021, CDSCO released a notice requesting all stakeholders involved in clinical trials for the online submission of SAE reports through the SUGAM portal (www.cdscoonline.gov.in) from March 14, 2021. CDSCO will not accept physical/offline files of SAE reports for processing from March 14, 2021. The online submission of SAE reports is expected to reduce the time and transaction cost. To enable a smooth transition to the online platform, CDSCO has developed a user manual and video tutorial, which is now available on the CDSCO website. To report SAE on the SUGAM portal, the sponsor will have to follow a set of steps to fill up the database and for proper linking of data. All steps have been explained in the user manual with the help of screenshots for ease of understanding. It should be noted that the follow-up reports of SAE reports which are already submitted can be continued to be submitted in offline mode.

Current Regulatory Scenario for Conducting Medical Device Clinical Trials in India · Cliniexperts

Tue, 02 Aug 2022 17:49:46 GMT

Current Regulatory Scenario for Conducting Medical Device Clinical Trials in India

Medical devices complement the physician’s or surgeon’s expertise in examination, diagnosis, treatment, or follow-up. Access to medical devices helps a physician come up with the right diagnosis of the patient’s medical condition, or a surgeon to carry out a procedure accurately. These devices enjoy equal importance as drugs and are also subjected to clinical trial process through pilot, pivotal and post-approval studies. So clinical trials are conducted worldwide not only by pharmaceutical companies for approval of their drugs, but also by various medical device manufacturers before their devices are introduced in the medical market.

Regulations for medical device clinical trials in India

India is already one of the best destinations to conduct clinical trials for Investigational New Drugs (IND), and various pharmaceutical companies send numerous drugs to be tested on the Indian population for their safety. But this is not the case for medical devices, as earlier, they were put under the same umbrella as new drugs, biologicals, and vaccines. In India, clinical trials were guided by the same regulations, i.e. Schedule Y of the Drug & Cosmetics Rules, 1945. Medical device manufacturers were unwilling to accept these rules, which led to a situation of only a small number of clinical trials for medical devices in India. It took some time for Indian regulations to be amended. The Drugs and Cosmetics Rules, 1945, were reframed for medical devices as Medical Devices Rules, 2017. These rules became effective from January 1, 2018 for medical devices, including in vitro diagnostic kits, surgical dressing, mechanical contraceptives, and others. The Indian Union Government, after consultation with the Drugs Technical Advisory Board, further amended the Medical Device Rules, 2017, to Medical Devices (Second Amendment) Rules, 2019. Also, the rules and regulations for clinical trials of new drugs are amended from time to time to protect the human health by confirming the safety and efficacy of every new drug before its introduction in the market.

The pharmaceutical companies, as well as the medical device manufacturers, are guided by these rules and regulations for clinical trials. Medical device manufacturers must stringently abide by the rules and regulations of the Indian government, when conducting a clinical trial and getting approval for the sale of their products in the Indian market.

What are the Medical Device Rules in India?

Some of the salient features of the Medical Device Rules are listed below. It is necessary for any medical device manufacturer to understand them to subject their devices first for clinical trials, and then introduce them for sale in the Indian market.

The rules classify medical devices based upon the intended purpose, invasiveness, and duration of implantation of the device. For example, the invasive medical devices that are intended for less than 60 minutes of continuous use are classified as Class A. The In-Vitro Diagnostic (IVD) medical devices are classified according to the intended purpose of the devices. Thus, there is a need for a clinical trial for each of the classified type of medical device.
In case two or more devices are intended to be used with each other, the classification rules of each device shall be applied separately.
Earlier, there were only 14 notified categories for investigational medical devices that required investigation. But now there are 351 medical devices under 29 categories, and 247 IVDs under 21 categories that require clinical investigation. A sponsor cannot investigate it without approval from CDSCO (Central Drugs Standard Control Organisation) and the institutional ethics committee. CDSCO approval is required even for a medical device that claims to have substantial equivalence to a predicate device.
Similar to the pharmaceutical research, the sponsor is required to give any medical management or compensation, if required, to the patient in case of any causality or death due to the investigational medical device.
Every study must be mandatorily enrolled in the Clinical Trial Registry of India before the first patient is enrolled. Further, the status of the study — open, completed, or terminated — must be submitted annually to CDSCO by the sponsor.

These are just a few examples of the requirements to conduct a clinical investigation of a medical device in India. But there are many more rules and all of them must be followed stringently for smooth approval of the investigational medical device. There are various forms, data, and other documents that need to be submitted before, during, and after the completion of the investigation. Also, the conduct of the clinical investigation must be done according to the approved study protocol and CDSCO Good Clinical Practices guidelines.

Nitty-gritty of clinical trials for medical devices

Clinical investigation of a medical device is not a simple process, and amendments to the existing rules make it complicated. The pharmaceutical or medical device company may not be aware of the recent amendments, which could cause a delay in the approval or rejection of the application for a clinical trial. Seeking the assistance of an expert who is aware of all the facts and amendments is necessary for the application process to be smooth, until its approval.

CliniExperts is your desired partner possessing expertise for understanding medical trials in India. The medical device clinical trial related services of CliniExperts helps its clients at every step. These include, but not limited to:

Investigator / Site Identification
Site Training & Management
Project Management
Vendor Management
Medical Writing (E.g., Clinical Study Protocol and Clinical Study Report preparation)

The team consists of well-experienced, qualified, and competent professionals who are always up to date with the latest guidelines and amendments. Our clients speak about their journey, and we are proud of our achievements.

Conclusion

Indian regulations are stringent for clinical investigation of medical devices. To navigate the very complex regulations for medical device clinical trials in India, the manufacturer can shift their burden to CliniExperts and trust them with the journey for a smooth approval.

COVID-19 Vaccine Development: Key Developments in India · Cliniexperts

Tue, 02 Aug 2022 17:42:34 GMT

COVID-19 Vaccine Development: Key Developments in India

The Covid-19 emergency has propelled a race for preventive vaccines and treatment, with numerous efforts by companies, commercial consortia, and scientific organizations worldwide.

India is a hub for vaccine production and produces 60 percent of the world’s vaccines. Indian companies have played a pivotal role in producing and distributing vaccines worldwide through organizations like UNICEF, Gavi, and WHO.

CDSCO to Fast Track COVID-19 Vaccines

Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, has announced to fast-track the regulatory approval process for vaccines, diagnostics, prophylactics, and therapeutics designed to prevent or treat COVID-19.

As part of an effort to provide quick access to vaccines and drugs to manage COVID-19, the CDSCO is creating a dedicated coronavirus unit to address inquiries on the development of these products. As per the CDSCO notification:

Any firm or research institute with a protocol for repurposing existing drugs/vaccines for the treatment of COVID-19 will be given priority for review and approval.
Applications for clinical trial permission and application to import or manufacture drugs or vaccines for sales and distribution would be processed on priority through expedited review and accelerated approval.
CDSCO will also be expediting reviews and approvals for drugs and vaccines already approved in other countries. As per this measure, any firm having a drug or vaccine already approved for COVID-19 in any other country can directly approach the Drugs Controller General of India (DCGI) for expedited review and accelerated approval. This step will help reduce the time for crucial drugs and vaccines to reach the market.
On a case-by-case basis, CDSCO may agree to abbreviate, defer, or waive the need for developers of drugs and vaccines to generate animal toxicity, clinical, stability, and other types of data related to COVID-19.
CDSCO also plans to process applications to manufacture or import COVID – 19 drugs or vaccines for test, analysis, or clinical trial within seven days.

Indian Companies – Key Players in the Global Vaccine Industry

The leading companies working towards developing a COVID-19 vaccine are Serum Institute of India, Bharat Biotech, and Zydus Cadila.

Serum Institute of India, a pioneer in vaccine development, has collaborated with Codagenix, an American biotech company, to develop a “live attenuated” vaccine. The vaccine candidate, developed using synthetic lab-made coronavirus using Codagenix’s deoptimization technology, is in the preclinical stage. The vaccine is expected to enter human clinical trials in the coming months and be market-ready by early 2022.

Bharat Biotech has partnered with the University of Wisconsin Madison and US-based firm FluGen to develop a unique vaccine against COVID-19 called CoroFlu. CoroFlu will be developed on the backbone of FluGen’s flu vaccine candidate known as M2SR.

Zydus Cadila is working on two vaccine approaches – the first approach includes the development of a DNA vaccine against the viral membrane protein of the virus, while a live attenuated recombinant measles virus (rMV) vectored vaccine will be developed in the second approach.

Premas Biotech, a company that specializes in creating recombinant protein for vaccine development, has out-licensed its vaccine candidate to Akers Biosciences Inc, USA. As per Premas Biotech, these recombinant proteins target the three proteins on the SARS-CoV-2 virus: the spike protein, envelope protein, and membrane protein. The ability to target all three offers a strong case for the vaccine.

Other Indian companies in the COVID-19 vaccine landscape include Biological E, Indian Immunologicals, Mynvax, Auro Vaccines, and Gennova Biopharmaceuticals.

Way Forward – High Hopes Pinned on India

As countries across the world look forward to the development of both preventive vaccines and treatment for Covid-19, the challenges of access and scaling up of manufacturing capacities for delivering therapies to millions of people cannot be overlooked. With the world collaborating to find a viable vaccine for Covid-19, high hopes set on India – the powerhouse of vaccine manufacturing.

Enabling large scale manufacturing, advancing rapid regulatory reforms and collective action can help deliver the appropriate vaccine at the right time to the right person. References

- When ready, a coronavirus vaccine must reach all. https://www.natureasia.com/en/nindia/article/10.1038/nindia.2020.81
- Indian manufacturers account for 60% of vaccine supplies made to UNICEF. 2017. BioSpectrum. Asia Edition. Available at: https://www.biospectrumasia.com/opinion/37/9356/indian-manufacturers-account-for-60-of-vaccine-supplies-made-to-unicef.html. Accessed on: 23 May 2020.

Clinical Trials For COVID-19 · Cliniexperts

Tue, 02 Aug 2022 17:41:12 GMT

Clinical Trial For Coronavirus COVID-19

The COVID-19 pandemic continues to spread globally despite lockdowns and restrictions. The lack of definitive treatment for the deadly virus has propelled research towards a multipronged approach to mitigate transmission, morbidity, and mortality. In response to the global emergency, clinical trials assessing the efficacy and safety of interventions to manage the deadly disease are emerging at an unprecedented rate. Vaccines are viewed as the best strategy to handle the pandemic, but the need of the hour is finding therapies to treat those already infected. Two main approaches being utilized in this direction are:

Repurposing already existing therapeutic medicines.
Fast-tracking new drug development against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the virus that causes COVID-19

Repurposing Medicines

In drug repurposing, the focus is on medicines that have already been approved for another disease or are in a particular stage of clinical development. Repurposing drugs is a viable option as they can be converted more quickly than a completely new development. Medicines currently being repurposed for their suitability against Covid-19 belong to one of the following three groups:

Antivirals
Immunosuppressants/Immunomodulators
Medicines for lung patients

Antiviral medicines

Antiviral agents are designed to block the reproduction of the viruses or prevent them from entering lung cells. Antivirals being repurposed include drugs that were originally developed for hepatitis C, influenza, Ebola, Severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS) and human immunodeficiency viruses (HIV). Major drugs in this category which are being tested are Remdesivir, Leronlimab, Lopinavir/Ritonavir, and Favipiravir. Trials are also testing hydroxychloroquine and chloroquine, a well-known anti-malaria medicine proposed to have antiviral and immunomodulatory properties.

Immunosuppressants/Immunomodulators

For the latter phase of recovery, hospitalized patients with COVID-19 can develop a syndrome of dysregulated and systemic immune overactivation that worsens acute respiratory distress syndrome and can lead to multisystem organ failure. Hence, several studies aim to curb excessive immune reactions in terminally ill patients. Trials are testing immunosuppressants such as

Tocilizumab (anti-IL-6 used in the treatment of rheumatoid arthritis)
Adalimumab (anti-TNF)
Eculizumab (anti-C5)
Sarilumab (anti-IL-6)
Ixekizumab (anti-17A)
Fingolimod (sphingosine-1-phosphate receptor modulator, used against multiple sclerosis)

Trials are also investigating immune stimulation properties of the following drugs:

Tocilizumab (anti-IL-6 used in the treatment of rheumatoid arthritis)
Anti-PD-1 antibody camrelizumab
Recombinant IL-2, CSA0001 (LL-37 antiviral peptide with immunomodulatory functions)
CD24FC [fusion protein that prevents Toll-like receptor (TLR) activation and activates immunosuppressive Siglec signaling]
Recombinant human granulocyte colony-stimulating factor (rhG-CSF)

Medicines for lung manifestations

Medicines are also being explored to tackle lung manifestations of COVID-19, such as idiopathic pulmonary fibrosis. One such example is pirfenidone from Roche. Pirfenidone is an anti-fibrotic, anti-inflammatory drug that counteracts the scarring of damaged lung tissue.

New Drug Development against SARS-Cov-2

Apart from repurposing drugs, several companies are testing new medicines against Covid-19. In this category, three main approaches are being harnessed:

Using existing early-stage projects for antiviral medicines
Convalescent plasma – Antibodies for passive immunization
New development of suitable active substances

Clinical Trials Assessing the Efficacy and Safety of Clinical Candidate Interventions

As of 23 May 2020, over 2845 clinical trials have been registered on WHO’s International Clinical Trials Registry Platform (ICTRP). Some of the major randomized clinical trials that have been published investigated the following interventions:

- - Lopinavir–ritonavir compared with standard of care
  - Hydroxychloroquine compared with best supportive care
  - Favipiravir compared with arbidol
  - Lopinavir–ritonavir compared with arbidol

Apart from the above, many non-randomized trials have investigated hydroxychloroquine versus hydroxychloroquine combined with azithromycin.

Computer models speculate that the new coronavirus would not bind to ACE2 as well as the SARS virus. However, the researchers found that the spike protein of the new coronavirus bound far better than computer predictions, likely because of natural selection on ACE2 that enabled the virus to take advantage of a previously unidentified alternate binding site. As per the researchers, this aspect provides strong evidence that that deadly virus was not human-made in a lab – any bioengineer trying to design a coronavirus that threatened human health probably would never have chosen this particular conformation for a spike protein.

Remdesivir – Positive Early Results from Covid-19 Clinical Trials

Remdesivir is one of the first drugs to demonstrate positive clinical trial data in COVID-19. Remdesivir is an antiviral agent originally developed for hepatitis C, however, the drug has undergone a lot of repurposing since its initial development. Remdesivir was studied as a treatment for the Ebola virus and now, its use is being explored in Covid-19.

On 29 April 2020, Gilead Sciences announced topline results from the Phase 3 SIMPLE trial. The phase III trial demonstrated similar clinical improvement in patients receiving a 10-day treatment of Remdesivir to those receiving a five-day treatment. More than 50 % of the patients in both treatment groups were discharged from the hospital by Day 14. At Day 14, clinical recovery was achieved in 64.5% of the patients in the 5-day treatment group and 53.8% in the 10-day treatment group.

Way Forward – The slow mutation rate of SARS-CoV-2 means that changes will emerge over the years

Hydroxychloroquine in COVID–19 – Hype or hope?

While several trials for COVID-19 offer hope, many have failed to demonstrate encouraging results. Hydroxychloroquine recently failed to meet endpoints and saw adverse events in a retrospective study. Patients treated with hydroxychloroquine also had a higher mortality rate in clinical trials in the US.

As per a multinational registry analysis, published on 22 May 2020 in the Lancet, there is no evidence of the benefit of hydroxychloroquine or chloroquine when used either alone or with a macrolide. The study states that previous evidence supporting hydroxychloroquine or chloroquine was derived from either small anecdotal studies or inconclusive small randomized trials. The registry comprised data from 671 hospitals in six continents and included patients hospitalized between 20 December 2019, and 14 April 2020, with a positive laboratory finding for SARS-CoV-2. The authors concluded that their findings suggest not only an absence of therapeutic benefit but also potential harm with the use of hydroxychloroquine or chloroquine drug regimens in hospitalized patients with COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for the treatment of COVID-19.

Although the development of vaccines against the new coronavirus is proceeding at an unprecedented pace, it is unlikely that they will be available for mass vaccination as early as 2020. Therefore, eyes are fixed on effective medicines which can be used to treat those already infected more quickly.

References

- WHO, International Clinical Trials Registry Platform (ICTRP). Available at: https://www.who.int/ictrp/en/ Accessed on: 23 May 2020.
- Thorlund K, Dron L, Park J, et al. A real-time dashboard of clinical trials for COVID-19. Available at: https://www.thelancet.com/journals/landig/article/PIIS2589-7500(20)30086-8/fulltext#seccestitle10 . Accessed on: 23 May 2020.
- Chen J, Liu D, Liu L, et al. A pilot study of hydroxychloroquine in treatment of patients with common coronavirus disease-19 (COVID-19). J Zhejiang Univ (Med Sci). 2020;49(2):215‐219. https://www.thelancet.com/journals/landig/article/PIIS2589-7500(20)30086-8/fulltext#seccestitle10

Key Insights from the Genome Analysis of the Novel Coronavirus · Cliniexperts

Tue, 02 Aug 2022 17:39:57 GMT

Key Insights from the Genome Analysis of the Novel Coronavirus

Ever since the first reports of COVID-19 in Wuhan, China, there has been considerable discussion and “debates” on the origin of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the causative virus of COVID-19.

In January this year, China shared the full RNA sequence of the novel virus publicly, which provided the base to researchers around the globe to initiate work and burrow deep into the virus.

The SARS-CoV-2 genome is an RNA molecule comprising 30,000 bases containing 15 genes, including the S gene, which codes for a protein located on the surface of the viral envelope. Genome analysis is being carried out in many parts of the world to characterize alterations in the genetic information of the virus. Sequencing viral genomes can help in understanding the variation of the virus, and conclusions can be drawn about their origin and different lineages of the virus in the population.

In this article, we discuss some key insights deciphered from the genome analysis of SARS-CoV-2 or the novel coronavirus.

Whole-genome sequencing

Whole-genome sequencing (WGS) is the process of analyzing the entire DNA sequence of an organism’s genome at a single time. Whole-genome sequencing can provide critical information and has the potential to revolutionize infectious disease management. Researchers can locate and identify the genetic changes that occur in the virus as it spreads through the population. This approach is useful to

Understand the transmission of the virus

Design treatments and vaccines
Monitor viral evolution
Prepare for the future

Phylogenetic network analysis to predict future global hot spots

Researchers from Cambridge, UK, and Germany conducted a phylogenetic network analysis of 160 complete SARS-Cov-2 genomes. Data from virus genomes sampled from across the world between 24 December 2019 and 4 March 2020 were included in the study. Through this analysis, the researchers reconstructed the early evolutionary paths of COVID-19 in humans — as infection spread from Wuhan out to Europe and North America. The researchers mapped some of the original spread of the new coronavirus through its mutations responsible for different viral lineages

The research revealed three distinct “variants” of COVID-19, with clusters of closely related lineages; they labeled the variants as ‘A,’ ‘B’ and ‘C.’

Type ‘A’ – The type with the “original human virus genome” and the closest type of COVID-19 to the one discovered in bats. Type A was present in Wuhan but was not the city’s primary virus type. Mutated versions of ‘A’ were observed in Americans reported to have lived in Wuhan, and many A-type viruses were found in patients from the US and Australia.
Type ‘B’ – It was Wuhan’s primary virus type ‘B.’ Type ‘B’ was prevalent in patients from across East Asia. Type B, however, didn’t travel much beyond the region without further mutations — implying a “founder event” in Wuhan, or “resistance” against this type of COVID-19 outside East Asia.
Type ‘C’ – The type found in the European population; found in early patients from France, Italy, Sweden, and England. It was absent from the study’s Chinese mainland sample but seen in Singapore, Hong Kong, and South Korea.

The phylogenetic network analysis traced established infection routes: the mutations and viral lineages connected the dots between known cases. As per the researchers, “phylogenetic” methods can help predict future global hot spots of disease transmission and surge.

Genomic Study Points to Natural Origin of COVID-19

There have been some outrageous claims that the new coronavirus causing the pandemic was engineered in a lab and deliberately released to make people sick. However, a new study published in the journal Nature Medicine debunks such claims by providing scientific claims that the novel coronavirus arose naturally. The researchers used bioinformatics tools to compare publicly available genomic data from several coronaviruses, including the novel one that causes COVID-19.

The researchers analyzed parts of the virus genomes that encode the spike proteins. Spike proteins are responsible for the distinctive crown-like appearance of coronavirus, and the coronavirus needs the spike protein to infect a cell. With time, each coronavirus has fabricated the spike proteins a little differently, and genome analysis can provide evolutionary clues about these modifications. Genome analysis of the spike protein has revealed some unique adaptations – one of these adaptations bestows the virus’s unique ability to bind to angiotensin-converting enzyme (ACE2) on human cells.

Further analysis showed that the backbone of the new coronavirus’s genome most closely resembles that of a bat coronavirus; however, the region that binds ACE2 resembled a novel virus found in pangolins. As per the researchers, if the new coronavirus was manufactured in a lab, scientists most likely would have utilized the backbones of coronaviruses already known to cause severe diseases in humans. This fact provides additional evidence that the novel coronavirus certainly originated in nature.

Way Forward – The slow mutation rate of SARS-CoV-2 means that changes will emerge over the years

Since January, researchers have analyzed thousands of SARS-CoV-2 genomes and tracked mutations that have arisen; however, there is a lack of compelling evidence that the mutations have had a significant change in how the virus affects us.

Researchers have observed that the coronavirus is mutating relatively slowly compared to some other RNA viruses; this is because virus proteins act as proofreaders can correct some mistakes. However, over a period of time, viruses can evolve into new strains or lineages that are distinctly different from each other. In the future, the coronavirus may pick up some mutations that help it evade our immune systems.

Sequencing more genomes will uncover new avenues in the virus’s history. Researchers are especially interested in studying mutations from such as Africa and South America, where only a few genomes have been sequenced.

References

Forster P, Forster L, Renfrew C, Forster M. Phylogenetic network analysis of SARS-CoV-2 genomes. Proc Natl Acad Sci U S A. 2020;117(17):9241‐9243.
Andersen KG, Rambaut A, Lipkin WI, Holmes EC, Garry RF. The proximal origin of SARS-CoV-2. Nat Med. 2020;26(4):450‐452.
Using whole genome sequencing to help combat COVID-19. University of Cambridge. Available at: https://www.phgfoundation.org/blog/wgs-to-combat-COVID-19

Vaccines for COVID-19: Time to Fast-Track · Cliniexperts

Tue, 02 Aug 2022 17:38:57 GMT

Vaccines for COVID-19: Time to Fast-Track

While most people are experiencing lockdown blues, scientists worldwide are working endlessly towards developing a viable vaccine for Covid-19 to knock down SARS-CoV-2, the deadly coronavirus. Research at a molecular level would help us understand the virus lifecycle and enhance our preparedness to develop strategies against SARS-CoV-2. Vaccines are one of the most practical preventive strategies which would help slow down the spread of COVID – 19 and save millions of lives.

COVID-19 Vaccine Candidates – The Frontrunners

The tremendous impact of the pandemic is paving the way for the evaluation of novel vaccine technology platforms.

As per an analysis published by Nature on 8 April, there are 115 candidate vaccines for COVID-19. Of these, 78 are active against the virus, and 37 have unconfirmed activity. The frontrunners that have transitioned into clinical development include

mRNA-1273 from Moderna
Ad5-nCoV from CanSino Biologicals
INO-4800 from Inovio
LV-SMENP-DC and pathogen-specific aAPC from Shenzhen Geno-Immune Medical Institute.

Moderna Coronavirus Vaccine Trial Shows Promising Early Results

On 18 May 2020, Moderna announced positive interim phase 1 data for its mRNA vaccine (mRNA-1273). Moderna was very prompt in its action and initiated it’s the testing of its vaccine within two months after sequence identification of the novel virus. The company announced that the vaccine candidate was found to be safe and provoked a strong immune response in a handful of healthy volunteers. The positive interim results have propelled the way to begin larger human trials soon.

Novel Vaccine Development Paradigms

A vital feature of the various vaccines being evaluated is the diverse technology platforms harnessed. The majority of the platforms tested are not the foundation for approved vaccines, but their experience in oncology has encouraged researchers to explore the opportunities that these approaches may offer for COVID-19. Some vaccine approaches which are being evaluated include:

Nucleic Acid (DNA And RNA)
Virus-Like Particle
Peptide
Viral Vector (Replicating And Non-Replicating)
Recombinant Protein
Live Attenuated Virus
Inactivated Virus

Approved vaccines based on recombinant proteins for other diseases can be advantageous as they can take advantage of pre-existing production capacity, while DNA or mRNA based novel platforms can bestow flexibility in terms of antigen manipulation

Adjuvanted Vaccines – Viable Vaccines at a Lower Dose

An adjuvant is a constituent of a vaccine that helps stimulate a better immune response. Adjuvants also lower the amount of virus needed for the production of a vaccine, allowing for a larger stock of vaccines to be manufactured, enabling vaccination of more people without compromising protection. GlaxoSmithKline, Seqirus, and Dynavax have committed to making licensed adjuvants with novel COVID-19 vaccines developed by other companies.

Need for Collaborations

Collaborations would play an essential role in ensuring that promising vaccine candidates can be manufactured in sufficient quantities and delivered to all affected areas. Strong international coordination and cooperation between companies, regulators, health authorities, and the government is the need of the hour.

The Coalition for Epidemic Preparedness Innovations (CEPI) has recently issued a call for funding to support global COVID-19 vaccine development efforts guided by three imperatives: speed, manufacture, and deployment at scale, and global access. “We maintain a dynamic portfolio management approach and will make our enabling science resources available globally. We urge the global vaccine community to collectively mobilize the technical and financial support needed to successfully address the COVID-19 pandemic through a global vaccination program, and provide a strong base to tackle future pandemics.”

Challenges

The ground-breaking efforts to vaccine development are currently unprecedented in terms of scale and speed. Given the emergency, there is a ray of hope that vaccines could be available by early 2021; however, this would require exceptional efforts and would represent a revolutionary change from the traditional vaccine development pathway, usually taking years. The paradigm shift will require innovative regulatory reforms and a scale-up of manufacturing capacity.

The current scenario depicts companies collaborating to ensure rapid vaccine development. The number of vaccine candidates and novel approached surely generates positivity; however, the road to success will be challenging, and roadblocks are almost inevitable. Though data from the antiviral remdesivir trial is encouraging, a vaccine will ultimately be the lifesaver.

References

Thanh Le T, Andreadakis Z, Kumar A, et al. The COVID-19 vaccine development landscape. Nat Rev Drug Discov. 2020;19(5):305-306.
Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Available at: https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-interim-phase-1-data-its-mrna-vaccine?mod=article_inline

GSR Notification #227: Paving the Way to Clinical Research in India (Part II) · Cliniexperts

Tue, 02 Aug 2022 17:38:07 GMT

The application for permission to conduct clinical research India of a new drug or investigational new drug has to be made in Form CT-04 in place of Form 44. The following are the new provisions to be followed during clinical trials’ conduction in India.

Clinical Trials Enrolment Status

The clinical trial enrolment status of the trial subjects should be submitted on quarterly basis to the central licensing authority. Six monthly status report, pertaining to whether the trial is on-going, completed or terminated, should be submitted in SUGAM portal.

Serious adverse event reporting timeline

Serious adverse event (SAE) reporting timeline for sponsor has been changed to 14 calendar days of the “knowledge of occurrence” of SAE and not “occurrence/onset of SAE”.

Termination of Clinical Research, India

In cases where the clinical trial is terminated early, the same should be reported to central licencing authority within a period of 30 working days. If there is occurrence of study related injury or death, compensation should be provided within 30 calendar days of receipt of orders from licencing authority.

Provision of Post-Clinical Trial Access

If the drug is beneficial, and there is no alternative therapy, investigator can recommend post trial access for the patient. In such cases ethic committee (EC) approval and patient/legal heir’s consent is required. The rule also states that there is no liability on sponsor for post-trial use of the drug by patient.

Provisions for bioavailability and bioequivalence (BA/BE) studies

Provisions like application process, inspection process, suspension or cancellation of permission have been defined in the new regulations. The permission to conduct bioequivalence studies is valid for a period of one year from the date of its issue, unless suspended or cancelled by the central licensing authority. The new rules have also laid down requirements of bioavailability and bioequivalence study centres registrations.

Compensation

There are no significant changes in payment of compensation and the process of determination of causality assessment. Requirement of medical management (in clinical trial or BA/BE study of new drug or investigational new drug) to be provided by the sponsor has been clearly defined. The sponsor has to provide free medical management to the subject as long as required “as per the opinion of investigator”, or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.

A provision for pre and post submission meetings

With the provision of pre-submission meetings, the applicant can seek guidance about the requirements of law and procedure applicable for their projects before making actual submission to the regulator. The applicants can discuss their projects with the regulators and subject experts by paying a certain amount of fee. In the provision of post-submission meetings, the applicant can seek clarification in person with regards to pending application and can discuss related queries. For this the applicant has to apply for a post-submission meeting with the officer designated by the central licencing authority within a period of fifteen days (from the date the query was received) for seeking guidance with regards to the queries concerning pending application.

Phase IV and Post Marketing Surveillance

The new rules make certain clear requirements for phase IV and post marketing studies. Phase IV (Post marketing) trial include additional drug-drug interactions/dose-response/safety studies & trials designed to support use under the approved indications. Such trials have to be conducted under an approved protocol comprising definite scientific objectives, inclusion/ exclusion criteria, safety/ efficacy assessment etc. in approved indication in approved patient population. While conducting such studies, all ethical guidelines (including compensation rule) have to be followed and drug may be given free of cost. For post marketing surveillance (or observational or non-interventional study) regulatory provisions and guidelines of clinical trial are not applicable as drugs are already approved for marketing. However, they need to be conducted as per an approved protocol with scientific objective and should follow inclusion/ exclusion of subjects as per approved package insert.

Reference

New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

GSR Notification #227: Paving the Way to Clinical Research India (Part I) · Cliniexperts

Tue, 02 Aug 2022 17:36:12 GMT

The New Drugs and Clinical Trials Rules, 2019 was declared by the ministry of health and family welfare on 25th March 2019 (GSR Notification #227). The key focus of the new set of rules is to encourage advances in clinical research India. The rules are meant to revolutionize the regulatory aspects for the conduct of clinical trials and the subsequent approval of new drugs. The New Drugs and Clinical Trials Rules, 2019 has been effective from 25th March 2019; however, the chapter four of the rules which pertains to “Ethics committee for biomedical and health research” came into action from 21st September 2019.

The new rules supersede Part XA and Schedule Y of Drugs and Cosmetics Rules and are applicable to all new drugs, investigational new drugs (INDs) for human use, clinical trial, bioequivalence/bioavailability study and ethics committee.

Clinical Trial Application fees and modified approval formats

The application fees have been hiked for Phase 1 to 4 clinical trials. Additionally, application and approval formats have been modified. Some of the modified forms are mentioned below:

Form CT04 – Clinical Trial Application Form (Replaces Form 44)
Form CT 04 A- Automatic Approval Information to CDSCO
Form CT 06 – Permission to Conduct CTs by CDSCO
Form CT 16- Application to grant of License to Import of New Drug for Clinical Trials (Replaces Form 12)

Clinical Trial Definitions have been revised

To bring in more clarity, many definitions have been newly incorporated, while some have been modified. As per the new definition, an orphan drug is defined as drug used to treat condition which affects not more than 5 lac persons in India.

Application review periods and automatic approvals

For the review and approval of clinical trial (CT) applications, fixed timelines have been put down.

Ninety working days for global clinical trials
Thirty working days for investigational new drugs (INDs) being developed in India. To encourage research and development in India, a new provision of “automatic approvals” has been introduced. If no response is received from the central licencing authority to the applicant within the said period (30 days), the permission to conduct clinical trial shall be deemed to have been granted by the central licencing authority. In such cases, before trial initiation the applicant is required to inform the central licencing authority in Form CT-4A; the central licencing authority on the basis of the said.

Clinical Research – Ethics committee

The new rules have incorporated significant changes in the constitution of ethics committee (EC). As per the new rules, the ethics committee should have a minimum of seven members from medical, non-medical, scientific and non-scientific areas with.

At least, one lay person
One woman member
One legal expert
One independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian At least 50% of members should not be affiliated with the institute or organization in which EC is constituted and every member of the EC shall be required to undergo such training and development programs. Two types of ethics committee have been defined:
- Ethics committee for clinical trial,
- Ethics committee for Biomedical and health research

Ethics committee registration certificate would be granted in Form CT-02 within a period of 45 working days. The validity of registration has been increased to a period of five years from the date of its issue. Application for the renewal of the registration can be submitted 90 days prior to the date of the expiry of the registration to ensure deemed continuity. As per the new rule, when a clinical trial site does not have its own EC, clinical trial at that site may be initiated after obtaining approval of the protocol from the EC of another trial site; however, in such cases the approving ethics committee should take responsibility for the study at another site or center and the approving ethics committee should be located within the same city or within the radius of 50 kilometers of the clinical trial site.

Reference

New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

Human Vaccines – Vaccines Developmental Paradigm India · Cliniexperts

Tue, 02 Aug 2022 17:33:17 GMT

Vaccines are one of the most beneficial and valuable disease prevention measures contributing to long-term health gains. Advancements in research have led to the development of novel vaccines and delivery technologies and this is has caused a paradigm shift in the way diseases are prevented and treated. Even though the field of vaccines have evolved and the trends seem encouraging, there is a global need for new vaccines to address current health threats such as Dengue, Ebola, and Zika.

Clinical trials (CT) are the cornerstone for the introduction of new vaccines. CT provides the safety and efficacy data to support the approval of new vaccines; it helps evaluate risks versus benefits of a prospective vaccine and thus plays a major role in the evaluation of marketing authorization applications. Additionally, CT provides data to support recommendations for the inclusion of a specific vaccine into national immunization programs.

The Transition from the Laboratory to Clinical Trials

Not all discovered vaccines reach the clinical trial stage. The transition of a novel vaccine candidate from the laboratory to clinical trials depends on the fulfilment of certain important criteria. Animal immunogenicity data, toxicity data, possible impact on public health, cost-effectiveness and pre-existence of a vaccine with a satisfactory risk-benefit profile are usually considered to advance vaccine development.

Before clinical evaluation of a prospective vaccine, a developmental plan should be formulated to ensure successful development. An ideal development plan would include the following:

Identification of the target population and their sociocultural factors
Risk assessment of the target disease and the vaccine itself
Understanding the incidence of the target disease and environmental factors
Identification of the dose and route of administration
Regulatory strategies

Vaccine candidate undergoes three phases of development in humans – Phase I, Phase II, and Phase III. Phase IV studies or post-marketing surveillance studies (PMS) are carried out following licensure of the product. Real-world data from PMS help to monitor the vaccine for safety and effectiveness in the population.

Conducting Clinical Trials in India

Clinical trials require regulatory and ethical oversight to ensure the protection of the trial participants as well as to ensure the scientific integrity of the resulting data.

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority in India which ensures the safety, efficacy and quality of drugs, cosmetics and medical devices. The Drugs Controller General of India (DCGI) heads the CDSCO and is the final regulatory authority for the approval of CT in India.

Process of obtaining CT NOC in India

SUGAM is an e-Governance system to discharge various functions performed by CDSCO. The software system is an online web portal where applicants can apply for No objection certificates (NOCs) to conduct clinical trials. As per the CDSCO, for permission to conduct CTs/import/manufacture of vaccines in India, Form CT-06/CT-20/CT-23 NOC should be used.

For any clinical trial, the study sponsor is the responsible person and has all the information. After receiving the CT-NOC from CDSCO and trial registration in the Clinical Trials Registry-India (CTRI), it is the responsibility of the sponsor to initiate and monitor the clinical trial in all the participating sites.

Sample size requirement and endpoints selection for vaccine studies

CDSCO requires the rationale and calculation for sample size requirement, anticipated drop- out rate etc. The sample determination may include H0 testing and desired power of the study.

Before initiating a vaccine study, the trial endpoints need to be defined; this aids in trial design and hypothesis formulation. It also guides the analysis of the data upon study completion and enhances the credibility of the study results. The following points should be considered while selecting endpoints for vaccine studies 7

The rate of occurrence of the endpoints in the population under consideration
The relevance of the vaccine effect on the endpoint
Reliability in measuring the endpoint

Some common endpoints used in vaccine studies include seroprotection rate, seroconversion rate, geometric mean antibody concentrations (GMCs) or titres (GMTs) and geometric mean titer pre-/post-vaccination ratio (GMRs).

The New Drugs & Clinical Trials Rules 2019

The Schedule 1st, 2nd, 3rd, & 5thand the Rules 21, 22, 23, 52, 59, 60, 67, 75 & 80 of the New Drugs & Clinical Trials Rules 2019 governs clinical research in India. All clinical research that falls within the scope of said rules must comply with the necessary requirements. Rules, 2019has 13 chapters which comprises of 8 Schedules and formats for clinical trial protocols, informed consent forms, ethics committee (EC) approval templates and a format for serious adverse event (SAE) reporting and clinical trial reports.

Ethical Guidelines of the Indian Council of Medical Research (2017)

The Indian Council of Medical Research (ICMR) guideline covers the general principles that need to be followed while conducting biomedical and health research in India. It also provides guidance related to special areas such as research in children or herbal research.

ICH-Good Clinical Practice Guideline

The International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) is an international ethical and scientific standard for conducting trials involving human participants. The GCP ensures that the rights, safety, well-being, and confidentiality of trial participants are protected and the data collected in clinical trials, as well as the reported results of clinical trials, are credible and accurate.

The Indian guideline on Good Clinical Practice Guideline was released by CDSCO in 2001.

Important Considerations while Conducting Clinical Trials in India

For conducting clinical trials in India the investigator must ensure that clinical trials are conducted as per the rules outlined below10

In compliance with an Ethics Committee and a DCGI approved protocol
In the case of IISs (Investigator-initiated studies) with ‘new drugs’, DCGI approval is no longer needed; only an EC approval is required
In compliance with GCP guidelines
All applicable regulations

All clinical trials need to have approval from a registered Institutional Ethics Committees (IECs). IECs registration should be renewed at the end of 5 years. Before the first study participant is enrolled, it is recommended that all studies are registered in the Clinical Trials Registry of India (CTRI). CTRI is a free, online portal that allows both investigator-initiated and regulatory studies to be registered.10

Important Considerations during trial conduction

The study investigator is in-charge of conducting the study and is responsible for the conduct of the trial at a site by personally supervising the investigations.11 Informed consent from each study participant is a mandatory prerequisite; investigators must ensure that written, informed consent is obtained from all participants in a clinical trial. An audio-visual recording of the informed consent process should be ensured for trials that involve vulnerable participants and involve a new chemical entity or a new molecular entity. The study investigator should follow the protocol thoroughly and ensure that all personals assisting in the study are suitably trained.

All serious adverse events (SAEs) encountered during the trial should be reported by the investigator to the DCGI, the sponsor and the IEC, within 14 days of their occurrence.

Conducting Clinical Trials in India – The Hurdles

Robust economic growth, proven capabilities in medical skills, IT capacity, and a large pool of scientific manpower, have advantageously positioned India for the conduct of clinical trials. However, challenges are still encountered while conducting clinical trials in India.12

Limited exposure to research in medical education has led to limited experience with clinical trials conduction. Lack of qualified investigators; lack of government-accredited clinical-research training institutions, biostatisticians, and epidemiologists further adds to the problem.
Media disseminating, unfavorable and inaccurate depictions abound clinical research is another concern – this may undermine trust and participation in clinical research.

Future Implications – Goals of Modern Vaccination

The ultimate goal of vaccination is to prevent or cure as many diseases as possible with the development of novel vaccines against emerging infections, cancers, and chronic diseases. Increasing the number of vaccine clinical trials and incorporating changes to foster medical expertise is the need of the hour. Another target is to improve the efficacy and safety of vaccines. Adjuvants are an essential component for increasing the efficacy of vaccines. Moreover, the advancements in genomic techniques and new vaccine-design methods have enabled the high-throughput screening of vaccine candidates with better safety profiles.

Concluding Remarks

With the increase in the quantity and quality of clinical vaccine development, the coverage of vaccines against diverse diseases will be broadened faster than ever. Developing efficient vaccine development strategies and streamlining the regulatory approval processes may help achieve these ambitious goals and save millions of lives.

References

Singh K, Mehta S. The clinical development process for a novel preventive vaccine: An overview. J Postgrad Med. 2016;62(1):4–11. doi:10.4103/0022-3859.173187
Han S. Clinical vaccine development. Clin Exp Vaccine Res. 2015;4(1):46–53. doi:10.7774/cevr.2015.4.1.46
Central Drug Standard Control Organization (CDSCO). Available at: https://cdsco.gov.in/opencms/opencms/en/Home/. Accessed on: 01 August 2019.
Central Drug Standard Control Organization (CDSCO) User Manual For e-Governance Solution for CDSCO. Available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/SUGAM_user_manual.pdf. Accessed on: 01 August 2019.
GSR 227(E): New Drugs and Clinical Trials Rules-2019, Ministry of Health & Family Welfare, Department of Health and Family Welfare, Government of India, 19 March 2019
Central Drug Standard Control Organization (CDSCO). Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy. Available at: https://www.kem.edu/wp-content/uploads/2019/06/CDSCO-Guidance-For-Industry.pdf. Accessed on: 01 August 2019.
Hudgens MG, Gilbert PB, Self SG. Endpoints in vaccine trials. Stat Methods Med Res. 2004;13(2):89-114.
ICH harmonised tripartite. Guideline for good clinical practice E6. 1996. Available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf . Accessed on: 01 August 2019.
Saxena P, Saxena R. Clinical trials: changing regulations in India. Indian J Community Med. 2014;39(4):197–202. doi:10.4103/0970-0218.143018
Gogtay NJ, Ravi R, Thatte UM. Regulatory requirements for clinical trials in India: What academicians need to know. Indian J Anaesth. 2017;61(3):192–199. doi:10.4103/ija.IJA_143_17
Burt T, Sharma P, Dhillon S, Manchanda M, Mittal S, Trehan N. Clinical Research Environment in India: Challenges and Proposed Solutions. J Clin Res Bioeth. 2014;5(6):1–8. doi:10.4172/2155-9627.1000201

Periodic Safety Update Report (PSUR Consideration) · Cliniexperts

Tue, 02 Aug 2022 17:28:19 GMT

Periodic safety update reports (PSUR Consideration) are pharmacovigilance documents that allow a periodic but comprehensive assessment of the risk-benefit balance of a medicinal product after it is marketed. The main purpose of the PSUR is to identify new or emerging safety information, as a means of determining changes in the benefit-risk profile of the authorised drug. Periodic safety update reports are an effective mode of risk communication to the regulatory authorities and an important indicator for the requirement of risk management strategies.

Periodic safety updates reports: The procedure as per the “New Drugs and Clinical Trials Rules, 2019”

The applicant has to provide PSURs to report all relevant new information from appropriate sources and relate the data to patient exposure. The market authorisation status in different countries and any significant safety variations observed should be summarised. The applicant has to indicate whether alterations would be made to product information in order to optimise the use of product. All dosage forms and formulations as well as indications for new drugs can be covered under one periodic safety update report. Within the single PSURs data for different dosage forms, indications or separate population have to be mentioned separately. All pertinent clinical as well as non-clinical safety data should be covered only for the period of the report.

Periodic safety update reports (PSUR Consideration): Submission

After approval of the drug is granted, for the initial two years, PSURs should be submitted every six months. For the subsequent two years, PSURs have to be submitted yearly. If deemed necessary (with regards to public health) by the central licencing authority, the total duration of submission can be extended. Periodic safety update reports which are due for a certain time frame should be submitted within thirty calendar days of the last day of the reporting period. An exception to this are cases involving serious unexpected adverse reactions; such cases must be reported to the licencing authority within fifteen days of initial receipt of the information by the applicant. The PSUR should be structured as specified in the fifth schedule (Post market assessment) of the New Drugs and Clinical Trials Rules, 2019.

Reference

New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

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