Indian Council of Medical Research (ICMR) will be shortly finalizing a national registry for clinical trials on the lines of similar efforts by the US to have an easy access of the trial reports to the public. The move is in the wake of increasing number of clinical trials taking place in the country and to counter possible unethical practices by CROs.
The national registry is reported to be ready and is into trial run. It will have six parameters and it would be linked to the WHO clinical trial registry platform, a global network. It would help the public to access information at a single point, sources said.
The WHO has recently called for registration of all trials involving humans at the earliest stage of development. Two years after some medical journals took the initiative to get trials registered across the world. The International Committee of Medical Journal Editors in July 2005 made it mandatory the registration of trials for publication of findings and reports in 12 leading medical journals worldwide. This triggered a sudden spurt in the registration. The US Government registry receives 200 entries every week now.
With number of trials shooting up and complaints of unethical practices in the absence of regulatory framework in India, the proposed registry is expected to extend useful information to public and activists alike. The registry would give information about a trial's purpose, who may participate in trials, how recruitment of patients is done, etc. It would also help to stop the practice of suppressing negative results by the companies ensuring better transparency. They will allow academics, regulatory bodies, public interest groups or study participants to review completed studies. They can also facilitate analyses that statistically combine other studies to evaluate the safety and efficacy of drugs.
According to available reports, at least 270 clinical trials are going on in the country now whereas the number was just 120 in last April. Clinical trials in India cost 50 per cent less than the average cost in the US and recruitment of patients were said to be far easier, prompting the multinationals to shift focus to India.