Clinical trial registry ‘doesn’t exist’, ‘ghost staff’ runs tests | India News - Times of India

peter.suber's bookmarks 2022-08-12


"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.Even as the government fights the regularisation of the staff who have been running CTRI for the last 16 years, CTRI continues to receive hundreds of applications for clinical trials. Trials worth crores of rupees could be stalled if the registry becomes non-functional. The CTRI is a completely paperless online repository of data of more than 45,000 registered clinical trials. It is publicly accessible and searchable and is maintained by a handful of data entry operators, a few scientists and statisticians. 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.This is despite the Drug Controller General of India making it mandatory to register all clinical trials from September 15, 2009 and a 2013 amendment in the Drugs and Cosmetics Rules 1945 which mandated that clinical trials needs to be registered with CTRI before enrolling the first participant for any study. Editors of biomedical journals of India also insist on trial registration as a precondition for considering publication of trial results and so do several ethics committees...."


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Date tagged:

08/12/2022, 13:43

Date published:

08/12/2022, 09:43