Explained | What are the problems with India’s clinical trials registry? Premium

A paper by an expert explains the problems with India's clinical trials registry and offers solutions to transform it into a world-class registry.

The speedy approval of Covid-19 vaccines during the SARS-CoV-2 pandemic spotlighted the importance of clinical trials. Terms like “vaccine efficacy” and “clinical trial”, previously restricted to medical research circles, became a part of everyday language.

Despite their success, the haste with which some Covid-19 vaccine-related phases were cleared in India raised several questions regarding the transparency of the clinical trials and the safety and efficacy of the vaccines themselves.

One way to ensure a clinical trial is transparent is to make sure all information about it is freely accessible in the public domain. And that is what the Clinical Trials Registry-India (CTRI), where every trial is required to be registered before commencing does — or tries to.

Hosted with the Indian Council of Medical Research’s National Institute of Medical Statistics, the CTRI is a free, online public-record system to register clinical trials being conducted in India. It was launched in July 2007 for use on a voluntary basis. In June 2009, the Drug Controller General of India (DCGI) mandated all trials to be registered there.

Any trial that uses human participants and is testing drugs, surgical procedures, preventive measures, lifestyle modifications to devices, educational and behavioural treatment, and rehabilitation strategies must be enrolled in the registry.

To register, the trial sponsor needs to make a public declaration, identify investigators, define participant selection criteria, seek the Drug Controller’s approval, and arrange to receive the approval of the ethics committees at the various trial sites.

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