The Unit has a long history of actively contributing to initiatives in the UK and in LMIC partner countries to improve processes and systems that support clinical research, in particular clinical trials.
In India, the focus has been to co-develop infrastructure, processes and tools that add long term value and to contribute to national policy in the area of ‘clinical trials/studies’.
This is based on the NIHR toolkit for academic clinical trials in the UK It provides pertinent information to researchers, planning a clinical trial in India. It incorporates the best practices 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 several Indian experts/stakeholders from academia and industry. The toolkit was launched by Dr Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India at the Global Bio-India summit on 22 November 2019.
We support development of leadership and domain expertise in clinical trials through knowledge exchange and mentorship. Some key partners include Clinical Development Services Agency (http://www.cdsaindia.in/), a clinical trials unit at the Translational Health Science & Technology Institute (http://thsti.res.in/) and the Clinical Research Unit ( at The All India Institute of Medical Sciences (AIIMS), New Delhi (https://www.aiims.edu/en/hospital-services-blood/236-notices/miscellaneous/10340-amendment-of-recruitment-rules-for-the-post-of-scientist-%E2%80%93ii-for-clinical-research-unit-cru-under-research-section-at-aiims-.html)
This is done in partnership with the Clinical Development Services Agency. The first two e-learning short courses have been on ‘Current regulatory requirements for conducting clinical trials in India’ and ‘Regulatory requirements for medical devices and In-Vitro Diagnostics in India’. They were developed in collaboration with Central Drugs Standard Control Organisation.
In partnership with CDSA, Forum for Ethics Review Committees in India (FERCI) and PATH, we are developing an online ethics application system to stream line the workflow and processes of Indian ethics committees. We have contributed to the development of national ethics application forms and these have been incorporated into CReATe. Over 30 Indian Ethics Committees are currently using the system.