Ethical concerns over clinical trials in India
By 2010 India could capture clinical trials business of around US$ 1 billion, up from US$ 200 million in 2007, making the subcontinent one of the world's preferred destinations for clinical trials
As an increasing number of international drug companies are moving their clinical trials business to India, the clinical trial industry has been raising concerns about the lack of regulation of private trials carried out there, including the uneven application of requirements for informed consent and proper ethics review.
There is now a new urgency for the reform of clinical trials registry in the subcontinent.
Dr Ambujam Nair Kapoor, a senior scientist of the Indian Council of Medical Research (ICMR), stated: ‘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 Trials Registry of India, which was launched in July last year. This encourages the registration of all clinical trials conducted in India before the enrolment of the first participant. Dr Kapoor, who added that the Registry is meant to bring transparency to clinical trials conducted in India, is very 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 publicised,’ she said, adding that information about failures should also be put in a publicly searchable database.
Working with the Indian Journal of Medical Research, early this year the Clinical Trial Registry also brought together the editors of 12 Indian biomedical journals to develop policy covering the publication of clinical trials. The 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 Trials 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 Trials Registry Platform (ICTRP) and of the steering group of the Clinical Trials Registry.
The 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 International Committee of Medical Journal Editors (ICMJE) published a joint editorial promoting registration of all clinical trials. The ICMJE stated that, from 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 World Health Organisation Primary Registry.
The 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. This culminated in the establishment of the ICTRP Secretariat, which began operations in August 2005. It is committed to harmonising standards within which trial registers and databases worldwide can operate in a coordinated fashion, providing a global trial identification and search capability, and promoting compliance.
For a full report published in the WHO Bulletin in August, go to: www.who.int/entity/bulletin/volumes/86/8/08-010808.pdf
01.09.2008
