Editorial: A welcome initiative
Published in The Hindu on May 31, 2008
At a time when India has become one of the most favoured countries for conducting human clinical trials and the number of papers on clinical trials published in Indian journals is rising, the decision taken recently by the editors of eleven Indian biomedical journals to publish only the results of trials that have been registered is laudable. This is particularly significant in view of the all too common practice of many pharmaceutical companies to manipulate human clinical trial results for drug approval and publication. Registering clinical trials in public registries before starting them is one way of ensuring greater transparency. Earlier, the number of trials registered was not high as registration was voluntary. But the decision taken by the International Committee of Medical Journal Editors (ICMJE), a group of 12 medical journal editors, in 2005 to publish only the results of registered trials brought about a perceptible difference. The number of registrations in one registry alone shot up by 73 per cent within five months that year. According to an editorial in the British Medical Journal published last year, the number of trials registered every week in the ClincialTrials.gov registry exceeds 200. The success of the novel initiative has had a cascading effect and has prompted many journals to join the growing ranks of publications insisting on registration.
One can expect a similar compliance by the pharmaceutical industry undertaking trials here following the decision of the Indian editors. All trials have to be registered prospectively if undertaken after June this year, and retrospectively if started before, in order to be considered for publication in the eleven journals after January 2010. The launch of the Indian registry last year by the Indian Council of Medical Research has made it easy for these editors to take a firm stand. By being linked to the World Health Organisation’s International Clinical Trial Registry Platform (ICTRP), the Indian registry has become an ICMJE acceptable platform for companies and institutions. Though the editors have done the right thing by not insisting on any particular registry, they have been a bit too lenient by giving a one-and-half year’s notice period before implementing their decision. This is particularly evident as the results of trials that are already underway will be published well before the January 2010 deadline. Registering trials does not solve the problem altogether, more so when it is only voluntary. The U.S. has changed all this by making it mandatory to register trials and submit the results as well. The need of the hour is for India to adopt a similar legislation to minimise the chances of data manipulation.
