Editorial: For transparency in clinical trials

Published in The Hindu on August 3, 2007

With the recent launch of an online, open-access registry, India has made a serious attempt to make human clinical trials more transparent and accountable. The first of its kind in Asia, the initiative by the Indian Council of Medical Research, coming in the wake of the World Health Organisation’s call for such a facility in member countries, is timely. The country has become an attractive outsourcing destination for multinational pharmaceutical companies, and there is the compulsion for Indian companies to develop original drugs. Drug companies have over the years been accused of staging unethical clinical trials. That many unapproved trials were carried out in the past and are still common in many developing countries with no proper regulatory mechanism is well known. The British Medical Journal highlighting another malaise prevalent in the projection of clinical trial commented: “By suppressing negative findings and exaggerating positive ones, by downplaying harms and talking up benefits, healthcare decisions are based on incomplete data and ultimately harm the patients.”

Though medical journal editors have been crying foul for a long time over the way drug companies cherry pick positive results and resort to multiple reporting of such results, it was only two years ago that the International Committee of Medical Journal Editors (ICMJE) made clinical trial registration mandatory for results to be considered for publication in the 12 journals. Since “Missing out on the chance of publishing favourable findings in prestigious journals by not complying with this policy is undesirable for industry…”, the ICMJE policy has in effect forced the industry to become transparent. A recent re-evaluation of the policy has found the response “overwhelming.” The need to register trials has become compelling with more journals adopting the policy. The near doubling of trials registered in the United States registry in a month after the policy announcement, and the registration of over 450 trials in India clearly indicate a change in the mindset. While the Indian registry will facilitate more registrations, the need to create awareness cannot be overemphasised. The drug industry was initially disinclined to fall in line but the ICMJE is setting the stage for compulsory disclosure of trial results. If successful, this will go far in furbishing the image of clinical trials.

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