Developing a clinical trials toolkit for India

A new clinical trials toolkit provides guidance to researchers intending to undertake clinical trials in India

India faces a number of health concerns, with infectious and non-communicable diseases both on the rise. Clinical trials and large cohort studies are key to developing effective treatments, providing the evidence required to inform healthcare practices. To support researchers undertaking such trials and studies, many countries have built a country-specific clinical trials toolkit. These toolkits provide practical advice on navigating the many regulations that govern clinical research and the design and conduct of clinical trials.

Recently, the Medical Research Council Clinical Trials Unit at University College London (MRC CTU at UCL) worked with the Clinical Development Services Agency (CDSA) at the Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology in the Government of India, to develop a ‘Clinical Trials Toolkit for India’. It was launched In late November 2019 by Dr Renu Swaroop, Secretary of the Department of Biotechnology, Government of India, at the Global Bio-India summit during the ‘Vaccinating India and the World’ session.

Adapted from the NIHR (National Institute for Health Research) Clinical Trials Toolkit for UK, the toolkit takes researchers through the steps they will need to consider whilst planning a clinical trial in India. It is based on best practice in research in India and globally and provides links to useful resources, guidelines and regulations, wherever possible.

The development of the toolkit has involved extensive consultation with Indian academic and industry experts. It is in accordance with the Indian New Drugs and Clinical Trial Rules 2019, the Indian Drugs and Cosmetic Act, Good Clinical Practice Guidelines, and the Indian National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.

Professor Usha Menon, who leads the team developing and maintaining the toolkit said, “India has set out a national research agenda to address healthcare issues and build an Indian evidence base of safety and efficacy of health interventions. The clinical trials toolkit will prove invaluable in underpinning these efforts by supporting investigators undertake large-scale multicentre trials and representative cohort studies.”