Editorial: Accountability in clinical trials
Published in The Hindu on August 1, 2006
In a bid to meet a long felt need for more transparency and order in the way human clinical trials are conducted, the Indian Council of Medical Research has decided to start a registry by the beginning of next year. The many advantages that the country offers a large population, diverse gene pool, prevalence of many diseases, and low cost make it an attractive destination for global pharmaceutical companies keen on testing their new molecules. Less talked about is the scope for unethical trials arising from the large number of poor and uneducated people. Reports of the devious ways in which pharmaceutical companies carry out such trials in India and other developing countries underline the need for a mechanism to protect the poor from being exploited. “Access to information is especially important for people in the developing world, where the potential for exploitation is greatest,” notes an editorial published in the British Medical Journal. A survey conducted by ICMR earlier this year brought out the scant regard Indian institutional committees have for guidelines on ethics: only 40 of the 179 committees were found to follow the guidelines. Apart from bringing about order and transparency, registration will help in strengthening clinical trial research. While human clinical trials are crucial to assess the safety of drugs, it is imperative that the issue of safeguarding the interests of people who knowingly or unwittingly become involved in such studies is accorded the highest priority.
India’s decision comes close on the heels of the World Health Organisation’s call for all medical research involving humans to be registered. By setting up an international clinical trial registry platform, to be launched later this year, WHO hopes to link all national registries and make it possible for a single point access to information about all trials, both ongoing and completed. The world body requires disclosure of information under 20 heads at the time of registration. Registering trials will also help in making available information about their positive and negative outcomes. This aspect gains special significance as companies rarely report negative results. Journals have been facing problems with such cherry picked and multiple reporting of positive results. The campaign to register trials got a shot in the arm with the International Committee of Medical Journal Editors, comprising some leading journals, mandating registration of trials that had begun since last September as a prerequisite for publication. “They [volunteers] deserve to know that the information that accrues from their altruism is part of the public record, where it is available to guide decisions about patient care, and deserve to know that decisions about their care rests on all of the evidence… ” notes the ICMJE statement. Though WHO and ICMR have not made registration of trials mandatory, the compulsion imposed by ICMJE will ultimately force companies to register their trials
