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Why are clinical trials necessary in India?
Subramani Poongothai1, Ranjit Unnikrishnan1, Jeyakumar Balasubramanian1
1Department of Clinical Trials, Madras Diabetes Research Foundation and Dr. Mohan's Diabetes Specialties Centre, WHO Collaborating Centre for Non Communicable Diseases Prevention and Control, International Diabetes Federation Centre of Education, Chennai, India.
Perspectives in Clinical Research
|April 18, 2014
Summary
Clinical trials are vital for drug development in India, offering participant benefits. Ensuring regulatory compliance and good clinical practice (GCP) training is crucial for India to lead globally in this field.
Area of Science:
- Pharmacology and Clinical Research
- Biomedical Sciences
Background:
- Clinical trials are integral to India's drug discovery and development commitments.
- Properly designed clinical trials are essential for robust new medicine evaluation.
- While controversies exist, clinical trials offer significant benefits to participants and scientific advancement.
Purpose of the Study:
- To highlight the importance of clinical trials in India's pharmaceutical landscape.
- To address concerns regarding clinical trials and emphasize the need for regulatory adherence.
- To underscore the potential for India to become a global leader in clinical research.
Main Methods:
- The abstract discusses the role and significance of clinical trials.
- It emphasizes the necessity of well-designed trials for drug evaluation.
- It touches upon regulatory compliance and personnel training in Good Clinical Practice (GCP).
Main Results:
- Clinical trials are a growing and essential activity in India.
- Adherence to regulatory norms and GCP training are critical for success.
- Addressing exaggerated concerns is important to maintain progress.
Conclusions:
- India is committed to clinical trials as a key part of drug development.
- Ensuring compliance and training will allow India to reap benefits and achieve global leadership in clinical research.
- Well-conducted trials are fundamental for scientific progress and participant safety.
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