The Hindu Business Line : WHO registry to inject transparency into clinical trials

Clinical trials undertaken by drug companies are often cloaked in secrecy and popular perception is one of suspicion. Drug companies are seen to be unwilling to disclose details of the drug they are testing on humans, especially when the clinical trial witnesses unfortunate adverse events.

But that may change. More transparency and accountability is expected to be brought into clinical trials undertaken by drug companies in the region, with India and China joining the World Health Organisation’s (WHO) clinical trial registry system.

Medical Journals

Drug companies will have to register their trial online before the enrolment of the first participant, besides disclosing details on the study — like the expected outcome of the trial, number of patients required, centres at which the trial will be done, etc — said an official with the Indian Council of Medical Research (ICMR). The Indian registry has been set up by ICMR’s National Institute of Medical Statistics, with support from the WHO.

Though registering on the site is voluntary, the ICMR official said, reputed medical journals are increasingly not publishing research papers from companies and scientists if trials are not registered. There is unwritten pressure on companies and researchers to register their trials.

Getting research data published in a reputed journal also helps in applying for a patent, as it establishes that a company was the first to work on the development. Indian companies looking to do serious research work are welcoming the development.

With the study being registered on a globally-accessible free site, companies are now forced to communicate not just the happy developments but also the unfortunate ones, the ICMR official said. This disclosure helps keep the system transparent and accountable, the official added.

China and India have a rapidly expanding clinical trial research sector, said a WHO note, on the recent development. “The Chinese Clinical Trial Register was established in 2005 and it has now met the criteria to submit its trial registry data to WHO’s Web search portal. The Clinical Trials Registry in India is the most recent of the world’s five primary registries, and was built to meet WHO’s reporting requirements,” it added.

People in these countries stand to benefit as they can access a complete picture of trials relating to diseases in the region.

The clinical trial market in India is projected to touch $1.5 billion by 2010, according to a McKinsey report. But the number of trials being done in the country are pegged anywhere between 300 and 500, said a representative with a clinical research organisation.

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