ICMR grants three-month extension to clinical trials database
India’s apex health research agency on Tuesday granted a three-month extension to a public database of clinical trials amid lingering uncertainty over permanency to a resource it had created 15 years ago to enhance accountability, transparency and rigour in research.
The Indian Council of Medical Research (ICMR) in an August 16 order approved the extension of the Clinical Trials Registry India (CTRI) from July 1 to September 30, after signaling earlier this year that the CTRI activities might stop on June 30.
The ICMR in June this year had denied extensions to seven CTRI staff members and told Delhi High Court and the Central Administrative Tribunal (CAT) that the CTRI established by the ICMR 15 years ago was not a permanent activity. The claim had surprised the medical research community because the CTRI had a critical regulatory role, as The Telegraph had reported on June 19.
Under drug regulations, proponents of every clinical trial need to register with the CTRI, outlining the trial’s objectives, protocols, locations, number of participants, among other details, before the trials start with the recruitment of its first participant.
Since its launch in 2007, the CTRI has registered over 44,000 trials by academic researchers, drug companies, vaccine makers, and post-graduate medical students.
The Indian registry is among 17 worldwide recognised by the World Health Organisation as a repository for clinical trials.
The seven staff members — two scientists and five data entry operators — have petitioned Delhi High Court for permanency to the CTRI and approached the CAT — a quasi-judicial body that examines service-linked issues — seeking their absorption as permanent CTRI staff.
On Tuesday, the seven staff members whose contracts had expired on June 30 also received three-month extensions up to September 30 this year.
Experts say the ICMR’s three-month extension to the CTRI appears intended to buy time. “What is the time being bought for? Is it to finally make it permanent or to just shut it down?” said Gayatri Saberwal, professor and dean at the Institute of Bioinformatics and Applied Biotechnology, Bangalore, who has analysed features of the 17 clinical trial registries worldwide.
“Presumably, it is also to decide how to staff the CTRI if it is to be made permanent,” she said.