With an aim to improve therapeutic regimens and ensure advancement in medical practice that is evidence based, the Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, is set to develop centres for phase-I clinical trial consisting of medical institutes across the country.
The centres will function as standalone facilities capable of effectively executing phase I clinical trials of the highest quality.
ICMR plans to have a memorandum of understanding (MoU) with government and private medical colleges and universities to identify and evaluate investigational products/lead molecules through these centres for phase I clinical trials.
Phase I studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects.
The toxicity data (adverse effects) derived from these studies are used to characterize the safety profile of the new medicinal product.
Phase 1 clinical trials typically focus on healthy participants in order to first determine whether medicines and vaccines are safe for use in patients and whether there are any side effects. The phase I study usually has 10 to 30 volunteers.
ICMR has sought an expression of intent from medical institutions with the necessary facilities and capacity available to participate as its centres for phase I clinical trials, which will enroll appropriate participants to successfully execute these trials. The last date for receiving application is July 8, 2022.
