Clinical Trials in India: A Complete Overview of Regulations and Procedures

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:

Resources Assist in Drug Clinical Trials in India

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.

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:

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

Frequently Asked Questions

Whether the enrollment status of trial subject should be informed to CLA?

Yes. The status of enrolment of the trial subjects shall be intimated to the CLA on quarterly basis or as appropriate as per the duration of treatment in accordance with the approved clinical trial protocol, whichever is earlier. Further, six monthly status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted in SUGAM portal. In case of termination of any clinical trial the detailed reasons for such termination shall be communicated to CLA.

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Frequently Asked Questions

Whether the enrollment status of trial subject should be informed to CLA?

Whether the enrollment status of trial subject should be informed to CLA?

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