ICMR approves extension of Clinical Trials Registry by three months

New Delhi: The apex research regulator, the Indian Council of Medical Research (ICMR) has granted a three-month extension to the Clinical Trials Registry India (CTRI), a free and online public record system for registration of clinical trials being conducted in India, from July 1 to September 30 despite an earlier sign that the CTRI activities might stop on June 30. 

Medical Dialogues team had earlier reported about how the Clinical Trials Registry India (CTRI) and its staff members had been functioning without any government extension, with registrations for over 1,060 clinical trials being done despite the non-extension of services. No official order extending the CTRI beyond June 30, 2022, was mandated by the government. 

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An uncertainty was lingering as it was not clear if CTRI, which began as a voluntary measure on 15th June 2009 and was created to enhance accountability, transparency, and rigour in research would be given permanent status. 

In June this year, while denying extensions to seven CTRI staff members, the ICMR told the Delhi High Court and the Central Administrative Tribunal (CAT) that the CTRI established by the ICMR 15 years ago was not a permanent activity, which caused surprise among the medical research community as CTRI played a critical regulatory role, reports the Telegraph India. 

The Clinical Trials Registry- India (CTRI), located at the ICMR's National Institute of Medical Statistics is a free and online public record system for registration of clinical trials being conducted in India and was launched on 20th July 2007. The trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI).

Proponents of every clinical trial are required to register with the CTRI, detailing the trial's objectives, protocols, locations, number of participants, etc before the trials start with the recruitment of its first participant. It is a completely paperless online repository of data from more than 45,000 registered clinical trials by academic researchers, drug companies, vaccine makers, and post-graduate medical students. However, the CTRI has been running in project mode with regular extensions instead of being given permanent status. The World Health Organisation has also recognized CTRI as a repository for clinical trials. 

The seven CTRI staff members, two scientists, and five data entry operators, who were denied extension had approached the Delhi High Court requesting to give permanent status to CTRI and had approached the CAT, a quasi-judicial body that examines service-linked issues, seeking their absorption as permanent CTRI staff. 

However, on Tuesday, these seven staff members whose contracts had ended on June 30 received a three-month extension up to September 30 this year. But according to experts, the extension given to CTRI is an attempt by the government to buy more time. Gayatri Saberwal, professor and dean at the Institute of Bioinformatics and Applied Biotechnology, Bangalore who has been analyzing the features of the 17 clinical trial registries worldwide said, "What is the time being bought for? Is it to finally make it permanent or to just shut it down?" She added, "Presumably, it is also to decide how to staff the CTRI if it is to be made permanent."

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