Understanding the Difference Between Clinical Trial and Clinical Study

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.

Clinical research services for various product lines

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/

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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Difference between Clinical Trial and Clinical Study

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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