The Indian national clinical trial registry CTRI has reportedly run out of funding, endangering the continued operation of a data hub that holds information on nearly 45,000 clinical trials, the Times of India reports (permalink here).
UPDATE 12 August 2022: The National Institute of Medical Statistics has Tweeted that the registry remains functional, without providing information on funding plans:
UPDATE 18 August 2022: Newly registered trials are reportedly being added to CTRI again. No news on funding.
"This is to bring to the notice of the concerned that the Clinical Trial Registry of India (CTRI) hosted at @icmr_nims is functioning to its full potential as against the misinformation being circulated in the media"
According to the newspaper:
“Officially, the Clinical Trial Registry of India (CTRI) does not exist anymore since there has been no official order extending its existence beyond June 30, 2022. The existing staff of CTRI also have not been given any further extension, but the supposedly non-existent ghost staff has registered over 1,060 clinical trials from July 1 till August 5…”
“The registry, which was started as a three-year pilot project in 2007, has been running in project mode with regular extensions since instead of being given a permanent status in the National Institute of Medical Statistics (NIMS), where it is physically housed.”
Public health activist Dinesh S. Thakur pointed out on Twitter that registering trials on CTRI is a national regulatory requirement under the New Drugs and Clinical Trial Rules 2019.
India’s apex health research agency has said a public database it created 15 years ago to register all clinical studies in the country and enhance transparency in research is not its “permanent activity”, evoking disbelief among researchers.
The claim made by the Indian Council of Medical Research (ICMR) to the Central Administrative Tribunal (CAT) that the Clinical Trials Registry India (CTRI) is “not a perennial or permanent project” contradicts its own documents that have represented the register as “a perennial activity”.
India’s drug regulations make it mandatory for any entity — academic, medical or industry — wishing to conduct regulatory clinical trials on patients or healthy volunteers in India to register the trial on the CTRI.
Scientists outside the ICMR familiar with the CTRI’s evolution say it was always intended to be established by the ICMR as a permanent activity but for reasons unclear this has not happened.
CTRI staff members — two scientists and five data entry operators recruited between 2006 and 2011 — weren’t "regularised" and continued to work on contracts that were renewed every six months or every year.
CTRI is one of over a dozen separate trial registries that feed data on clinical trials into the WHO’s global data hub ICTRP.
A recent report by Health Action International and TranspariMED flagged the perennial underfunding of the global trial registry system.
Many registries are run on a shoestring, which severely undermines data quality, the report warned:
“Frequently, these registries feed incomplete registrations into the global system that lack even basic data, such as the identity of a trial’s sponsor or the treatment being investigated. Research has repeatedly documented widespread inconsistencies between data for identical trials listed in two or more different registries.”
A 2019 study of the Indian registry found widespread internal inconsistencies, incomplete information, and missing data
Public health agencies, research funders and scientists worldwide rely on the global trial registry system to find out who is researching which drugs and medical devices.
If India’s CTRI registry were to completely shut down, it would tear a large hole into the world’s only comprehensive map of medical research activity.
To keep up to date on developments at CTRI, follow the journalist who broke the story, Rema Nagarajan, on Twitter.