Clinical trials in India: ethical concerns

Abstract

According to the Associated Chambers of Commerce and Industry, an influential national industry association, India is set to grab clinical trials business valued at approximately US$ I billion by 2010, up from US$ 200 million last year, making the subcontinent one of the world's preferred destinations for clinical Drug companies are drawn to India for several reasons, including a technically competent workforce, patient availability, low costs and a friendly drug-control system. While good news for India's economy, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and the uneven application of requirements for informed consent and proper ethics review. Dr Ambujam Nair Kapoor, a senior scientist of the Indian Council of Medical Research (ICMR), states the problem bluntly: Unless we put in place systems that ensure safety of patients and good quality of trials, people will get away with whatever they can get away with. ICMR, a national body responsible for the formulation, coordination and promotion of biomedical research, is striving to do just that with the Clinical Registry of which it launched in July 2007. Clinical Registry encourages the registration of all clinical trials conducted in India before the enrolment of the first participant. The registry is meant to bring transparency to clinical trials conducted in India, explains Kapoor, who is all too aware of the shortcomings of current trial publication practices, including a tendency to publish trial results only when they are positive. Trials done earlier where the drug has not been found to be effective are sometimes not publicized, she says, adding that information about failures should also be put in a publicly searchable database. Working together with the Indian Journal of Medical Research, the Clinical Trial Registry also brought together the editors of 12 Indian biomedical journals at the beginning of the year to develop policy covering the publication of clinical editors issued a statement in April urging all those conducting and/or planning to conduct clinical trials involving human subjects to register their trials in the Clinical Registry or any other primary clinical trial register. From January 2010 these journals will consider publication of a trial started in or after June 2008 only if it has been previously registered. We are wearing down the resistance [to registration], says Dr Prathap Tharyan, professor of psychiatry at the Christian Medical College, Vellore, India. Tharyan is the coordinator of the South Asian Cochrane Network, and a member of the Scientific Advisory Group of the WHO International Clinical Registry Platform (ICTRP) and of the steering group of the Clinical Registry. Investigators who want to publish in good journals have to register. In other words, if I want my research to be internationally known, I have to go to good journals who will increasingly insist on registration of the trials. [ILLUSTRATION OMITTED] latest developments in India reflect a concerted effort on the part of the global public health community to push clinical trials issues to the fore in the wake of several high-profile cases in which pharmaceutical companies were shown to be withholding information from regulators. In September 2004, for example, the members of the influential International Committee of Medical Journal Editors (ICMJE) published a joint editorial promoting registration of all clinical ICMJE stated that, beginning 1 July 2005, only registered trials would be eligible for journal publication. In 2007 the ICMJE stated that it would consider a trial for publication if it had been registered in any WHO Primary Registry. World Health Organization (WHO) has played a catalytic role in pushing this process forward. WHO's involvement in clinical trial registration began in October 2003 with consultations with different stakeholders to identify a potential basis for collaboration to address complex issues related to trial registration and reporting. …