India’s Clinical Trial Registry ‘Doesn’t Exist’, ‘Ghost Staff’ Runs Tests

The CTRI is a database of more than 45,000 registered clinical trials that is entirely paperless. Now, it has been revealed that the clinical trial registry ‘doesn’t exist’ and that ‘ghost staff’ runs the tests.

Clinical Trial Registry Doesn’t Exist Ghost Staff Runs Tests

Officially, the Clinical Trial Registry of India (CTRI) no longer exists because there has been no formal order prolonging its functioning beyond June 30, 2022. CTRI’s existing personnel has likewise been awarded no additional extensions, while the ostensibly non-existent ghost staff has registered over 1,060 clinical studies from July 1 to August 5, reports The Times Of India.

CTRI is still receiving a large number of requests for clinical trials even though the government is fighting to have the employees who have run it for the past 16 years regularized. If the registry stops working, trials costing billions of rupees could be delayed.

The CTRI is a database of more than 45,000 registered clinical trials that is entirely paperless. It is accessible to the public, searchable, and is kept up to date by a small group of data entry workers, researchers, and statisticians. Since its initial launch as a three-year pilot project in 2007, the registry—which is physically hosted at the National Institute of Medical Statistics (NIMS)—has operated in project mode with periodic extensions rather than being awarded a permanent status.

This is despite the Drug Controller General of India mandating the registration of all clinical studies beginning September 15, 2009, and a 2013 revision to the Drugs and Cosmetics Rules 1945 requiring clinical trials to be registered with CTRI before recruiting the first participant in any research. Several ethics boards, as well as the editors of Indian biomedical publications, require trial registration before contemplating publication of trial data.

However, in a lawsuit brought in the Delhi High Court by CTRI employees requesting that the registry be made a permanent function of NIIMS and also that their services be regularized. The government sustained that the CTRI was not a permanent feature of NIMS, which falls under ICMR, and that it was an initiative that was “extended from time to time.” It acknowledged that CTRI was now completely financed by ICMR, with funding originating from the health ministry. Making a project permanent or not is an executive role and hence a policy decision, according to the NIMS affidavit, which also asked if the court would intervene at all under the circumstances.

According to official correspondence that is attached to the petition, ICMR agreed to ensure the project’s continuation after the pilot years, and over time, the commitment was to make CTRI a regular activity of NIMS and to create positions at the institute for CTRI. Registration of clinical trials is referred to as “perennial activity” in a lot of ICMR correspondence.

Director of NIMS, M. Vishnu Vardhana Rao wrote the ICMR DG in a May 2021 letter and stated: “Considering the highly specialized and time bound nature of the work in CTRI, there is a need to accord five-year extension to the trained CTRI scientists and staff who have been working in the project for many years now in a reliable and consistent manner.”

“During the pandemic, including the lockdown phase, the CTRI staff continued to work 24/7, all days of the week to enable COVID studies to be registered at the earliest (often on the same day), providing hand holding as per need of the hour,” stated Rao’s letter.

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