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Regulating clinical trials

Here's the truth about clinical trial volunteers in India -- the number of registered volunteers has seen a steady rise ever since the Clinical Trials Registry (CTRI) was set up at the National Institute of Medical Statistics of the Indian Council of Medical Research (ICMR) in July 2007. Just to get a hang of how India has embraced clinical trials, despite the criticism of weak 'evidence-based' studies and lack of experienced clinical research professionals, the number of hits on the CTRI site crossed the 24,000 mark in April 2009 with more than 600 users registered.

CTRI also reports a rise in registered trials from 148 in December 2008 to 235 in April 2009. As of now, about 100 trials are pending with registrants for modifications/clarifications, while 50 trials are awaiting approvals from the Drug Control General of India. Biomedical journals in India have also shown their faith in the registry pledging to publish papers of clinical trials only if they are registered.

The move to create the registry for India and a few neighbouring countries who don't have their own registries was to "re-establish public trust in clinical trial data" following unethical practices adopted by the pharmaceutical companies for monetary gains.

Looks like the much needed regulatory push to clinical trials in India is finally in place. Have all the ethical questions surrounding good clinical practice (GCP) compliance been answered?

Posted by Subhra Priyadarshini on September 07, 2009
Categories: Health | | Comments (1) | TrackBacks (0)

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Do you or anyone trust ICMR or the so-called regulatory body Clinical Trials Registry (CTRI). The track record of ICMR to punish doctors proven (by a court of law) to be involved in criminal/illegal activities all over the country is simply pathetic. ICMR itself is ridden with rampant corruption, nepotism, just like any other govt organization in India. I’ll not be surprised if in one fine morning we read newspaper report that members of that CTRI and ICMR is in the regular payroll from the same organisations it was supposed to monitor and control. I was involved in one such company undertaking clinical trials. What they preach in public and what they do are totally different story.

Posted by: Jatin | September 20, 2009 01:21 AM

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