Summary:
New Delhi: The All India Institute of Medical Sciences is likely to submit a proposal to start phase 3 clinical trials in the hospital to the Institute of ethics committee for Bharat Biotech’s anti Coronavirus (Covid-19) vaccine candidate by early next week.
Bharat Biotech last week got an approval from drugs controller general of India to conduct phase 3 clinical trials of its anti Covid-19 vaccine candidate, Covaxin, in India, and AIIMS Delhi is one of the sites selected for trials that will be conducted across India.
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New Delhi: The All India Institute of Medical Sciences is likely to submit a proposal to start phase 3 clinical trials in the hospital to the Institute of ethics committee for Bharat Biotech’s anti Coronavirus (Covid-19) vaccine candidate by early next week.
Bharat Biotech last week got an approval from drugs controller general of India to conduct phase 3 clinical trials of its anti Covid-19 vaccine candidate, Covaxin, in India, and AIIMS Delhi is one of the sites selected for trials that will be conducted across India.
“The proposal is being prepared for the phase 3 trials, and within a couple of days we will be submitting it to the institute ethics committee for approval,” confirmed Dr Sanjay Rai, professor, department of community medicine, AIIMS Delhi.
Dr Rai is also the principal investigator for the Covaxin trials at the hospital.
For a trial to start at any of the approved sites, it is mandatory to secure clearance of the institute ethics committee.
As per the rules laid down by country’s biomedical research regulator— the Indian Council of Medical Research (ICMR), it is required for an ethics committee to oversee clinical research and thoroughly review the proposal at any site before allowing the trial to start.
AIIMS ethics committee consists 15 members, and is expected to take about 10-14 days to grant the necessary approvals.
“The proposal will be at least 200-300 pages and it takes time to go through it properly.