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Breaking news: All human clinical trials to be registered

Now, all human clinical trials to be registered
15 Jun 2009, 0429 hrs IST

BANGALORE: In a significant move aimed at making clinical trials on human beings more ethical and transparent, the Drugs Controller of India has

ruled for the first time that all clinical trials taking place across the country in all areas of health - new drugs, treatments, therapies, surgical procedures and new medical devices - must be compulsorily registered. The rule will come into effect on Monday.

Simply put, clinical trials and research conducted on human beings can now be accessed by the general public too. Hitherto, research institutions and companies obtained permission from the regulatory authorities and registration of the trials was voluntary.

Now, the Drugs Controller General of India (DCGI) has asked the Indian Council of Medical Research to ensure that while granting permission for clinical trials, the applicants are advised to get the trial registered before initiation of the study. 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.

"Over the last five years there has been accelerated growth in the number of clinical trials in India. There is a need to improve transparency and accountability in this field both for ethical and scientific reasons. In a way, it promotes greater trust and public confidence in clinical research. Primarily, it has been found that some research populations are particularly vulnerable and cannot give or refuse consent for themselves. The mandatory registration will avoid coercion or undue influence, sources told TOI.

The aim according to the DCGI is to prevent bias generated by selective reporting of only "positive" findings as well as reduce unnecessary duplication of research through greater awareness of existing trials and results. On its part, the Indian Council of Medical Research through its Bio-ethics initiative has developed ethical guidelines for the conduct of trials and for ethics committees.

Sources also concurred that it is impossible to arrive at the number of clinical trials that are taking place in the absence of a single authority that maintains records. "Though permission may be obtained now, the general public who are the ultimate benefactors of the whole exercise of clinical research are not in the know of things,'' sources stated.

What needs to be registered?

* All interventional clinical trials conducted in India and involving Indian participants

* An interventional clinical trial is a research study that prospectively assigns people to one or more health-related interventions (preventive care, drugs, surgical procedures, behavioural treatments, etc.) to evaluate their effects on health-related outcome

* Thus, early and late trials, trials of marketed or non-marketed products, random or non-random trials - all should be registered

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