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| Transparency in drug trials | | Clinical trials on human beings will now be regulated |
| Business Standard / New Delhi Jun 19, 2009, 00:19 IST |
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The regulation of clinical trials (testing of new drugs on human beings before they are approved) has taken a step forward with the registration of such trials being made mandatory. Such registration in a public registry, freely accessible to all, before the first volunteer is recruited, has several benefits flowing from greater transparency. At any moment it is necessary to know what kind of clinical research is taking place in the country to see if this matches the prevalent disease pattern. With mandatory registration, this will be easy to verify. If it is found that more clinical research is taking place in lifestyle-related diseases which have greater importance in developed countries than in life-threatening or infection-related diseases which are more common in the developing countries, then that will need addressing. Such a situation is conceivable as clinical research is an independent industry in itself and the contract research organisations, or CROs, which undertake them in India see a chance to earn global revenue.
An even more positive fallout of compulsory registration is greater public knowledge of the fate of trials, so that it is known what worked and what was abandoned. Drug companies have been in the habit of publicising only the results of successful trials and hiding failures. On the other hand, knowledge of failure serves a public purpose as that helps guide further research along correct lines. But registration and skimpy information are not enough to learn the full lessons from failures. For that it is necessary for the owners of trial data, the drug companies, to make it publicly available promptly. For example, if a contra-indication is evident in one trial, then knowledge of that will preclude others from going ahead with the same which can multiply distress among volunteers. Internationally, drug companies have resisted this as they have claimed that such data is commercially sensitive.
As far as India is concerned, making registration obligatory, and whatever little information it makes public, will be a gain. Not much registration took place since 2007, when it was started and compliance kept voluntary. Compulsory registration was inevitable when the editors of bio-medical journals in India, following the lead of their peers abroad, decided to publish from 2010 the results of only those trials started after 2008 which were publicly registered. A serious player will not undertake costly research unless it can gain mileage by publicising the result of successful research.
While compulsory registration marks progress, much more needs to be done to make clinical research in India safe. Poor and illiterate volunteers have neither the ability nor the incentive to be choosy in their role as guinea pigs. While protocols for good clinical practices have been laid down, the regulator till now has no system for regular audit and inspection of such practices. The same holds for ethics committees to supervise trials. While these have to be set up, they do not have to be registered. They need to be properly constituted, registered and mandated to follow guidelines.
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