The Drugs Controller of India has made it mandatory that all clinical trials on humans in the country must be compulsorily registered, in an effort to make clinical trials on human beings more ethical and transparent. This applies to all areas of health research - new drugs, treatments, therapies, surgical procedures and new medical devices.
Under existing norms, the Indian Council for Medical Research (ICMR), the apex body for biomedical research, has been overseeing clinical trials on humans in tandem with the World Health Organisation, but the reporting has been voluntary.
With the new notification coming to effect on 15 June, firms that have been approved by the Drug Controller General of India to conduct human experiments for a particular medicine will have to provide a clinical trials registry to the ICMR. This will record important information related to the trial such as the nature of the experiment, the source of funding of the trials, details of patients enrolled for the trial and the ethics committee that is responsible to oversee the patients enrolled into it.
The DGCI has asked ICMR to ensure that while granting permission for clinical trials, the applicants are advised to get the trial registered. The new rule mandates that trials should be registered before the enrolment of the first patient. Not just fresh human trials but even ongoing trials must be registered, the DCGI has said.
The aim, according to the DCGI, is to prevent bias generated by selective reporting of only "positive" findings as well as to reduce unnecessary duplication of research through greater awareness of existing trials and results. On its part, the ICMR, through its bio-ethics initiative, has developed ethical guidelines for the conduct of trials and for ethics committees.
The new ruling covers all interventional clinical trials conducted in India and involving Indian participants. Early and late trials, trials of marketed or non-marketed products, random or non-random trials, will all need to be registered.
An underlying reason for the new rule is that drug companies have been known to conduct unethical trials, undertake them without the permission of the government, publish only favourable results from specific sites, not report negative results, re-publish positive results in several journals, etc.
Apart from the academic and scientific importance of trial registration, the requirement will go a long way in helping the public, particularly those interested in enrolling as volunteers, as the details will now be in the public domain rather than restricted to scientific institutions.
The registry, which is freely accessible ( www.ctri.in), will help potential volunteers know more about the nature and prime objective of a trial, and if similar trials have been conducted in the past and the results thereof.
This is particularly useful to the public and health workers as India has become one of the major hubs for clinical trials. The major criticism that trials conducted in India are not up to international standards would become a thing of the past.
Many of those volunteering for a trial may not be literate or computer savvy. But the trickle down effect of the registry, it is hoped, will benefit even these people.