Tuesday, November 20, 2007

Clinical Trial Registry

NEW DELHI: Clinical trials conducted for testing efficacy of new drugs are set to become transparent with the launch of a national registry for recording such an exercise. The Clinical Trials Registry - India (CTRI), the first such initiative in Asia, was launched at the Indian Council of Medical Research (ICMR) here on Friday. Any researcher who plans to conduct drug trials on humans is expected to declare the details of the exercise in the Registry, that is jointly funded by the Department of Science and Technology, WHO and ICMR. Such prospective registration of clinical trials in humans before enrolling the first participant, and making sufficient information of ongoing research available to all those involved in healthcare decision making is now a national and international priority. "With the launch of this registry, India will be among the few select countries like Australia, UK and the US that are making researchers accountable through public disclosure," N K Ganguly, ICMR Director-General said. The objective is to restore public confidence in clinical research, which was being coed in some parts of the country in an hush-hush manner. "The CTRI will ensure that a complete view of ongoing research is available at the click of a mouse," Ganguly said. Twenty items that meet the requirement of the WHO International Clinical Trials Registry Platform will have to be declared at the time of registration. Only trials properly registered will be considered for publication in international research journals.

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