Editorial: More transparent clinical trials

Published in The Hindu on July 24, 2009

The recent decision of the Drugs Controller General of India to make registration of clinical trials mandatory is laudable and comes two years after the launch of an open-access Indian registry linked to the World Health Organisation platform. All clinical trials initiated after June 15 will have to be entered in the Indian Council of Medical Research’s Clinical Trial Registry — India. Pharmaceutical companies have, over the years, acquired the dubious distinction of conducting unethical trials that could even harm the volunteers. By making registration mandatory before enrolment of the first volunteer, the government has sought to bring more transparency and accountability to clinical trials. The U.S. Food and Drug Administration made registration mandatory in December 2007 for the same reason. But unlike in the U.S., Phase-I trials conducted here have not been excluded from registration. Even then the Indian arrangement is not comprehensive; in reality, registration becomes mandatory only when new molecules or new indications of an existing drug that requires the approval of the DCGI for marketing in the country are tested, or when India is part of a multi-country trial. The WHO and the International Committee of Medical Journal Editors (ICMJE) recommend registration of all trials involving humans, be it for interventional or other purposes.

Though the initial response had been rather lukewarm, with only 34 trials registered a year after the registry was started in June 2007, the numbers have shot up in the recent past. There have been 150 registrations this year, which is half the total registered so far. The figure is likely to see a spurt in the coming months. As the registry is freely accessible to the public, it would provide useful information to those intending to enrol as volunteers, and for those monitoring clinical trials. It would also minimise biased reporting by drug companies. More importantly, the three additional parameters required by the Indian registry would go a long way in improving the reporting standards of randomised clinical trials and hence the reliability of results published in Indian medical journals. Currently, many of the trial results that are published fall short of the international reporting standards primarily due to poor trial design. This leads to such trials being excluded by those undertaking systematic reviews and by developers of treatment guidelines, resulting in conclusions that may not be relevant to health care in India.