The All India Institute of Medical Sciences (AIIMS), Delhi is expected to submit a proposal to the Institute of Ethics Committee to seek permission for starting phase 3 clinical trials of Bharat Biotech’s anti-Coronavirus vaccine candidate Covaxin by early next week.
The development comes almost a week after Bharat Biotech got approval from the Drugs Controller General of India (DCGI) to conduct phase 3 clinical trials. AIIMS Delhi has been selected as one of the sites where final stage trials are slated to be conducted.
“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,” Dr Sanjay Rai, professor, department of community medicine, AIIMS Delhi, was quoted as saying by a report in Hindustan Times.
Dr Sanjay Rai is also the principal investigator for the third phase of Covaxin trials at the hospital. The hospital is expected to recruit around 2,000 to 5,000 participants for the third phase trial. The proposal will be sent as clearance of the institute ethics committee is mandatory for a trial to start at any of the approved sites.
As per the guidelines of the Indian Council of Medical Research (ICMR), the biomedical research regulator of the country, an ethics committee needs to review the proposal before allowing the trial of the third phase. There are around 15 members in the ethics committee of AIIMS and it is expected to take up to two weeks to grant necessary approvals.
“The proposal will be at least 200-300 pages and it takes time to go through it properly. The idea is to review and look for gaps, if any, that would address all concerns. The concerns that are usually raised almost always are valid, which you might miss otherwise. It helps,” Dr Rai was quoted as saying in the report.
His team had submitted the proposal for the phase 1 and 2 trials on June 30 and the clearance came through on July 18.
