Friday, August 19, 2005

Is your country attractive for clinical trials?

In an article recently published in Science, P.V. Padma examines the advantages of conducting clinical trials in India. It reads, initially, like a shiny tourist brochure: India-based trials are inexpensive, the country’s high population holds out the prospect of easy recruitment of subjects, many of the local health personnel speak English, and unlike Africa, Indians are increasingly suffering from the sorts of diseases afflicting Americans and Europeans, such as diabetes and heart disease. Potential study participants in India are also interesting to recruit given that they 'treatment naive' -- for reasons that should be obvious in the light of local per capital expenditures on health care. The list of attractions could be expanded. But why bother: many major drug companies are already sold on India, and have been scrambling to outsource their clinical trials there for the past few years.

Like any tourist brochure, the fine print lies buried somewhere under the glossy images. In this case, it is a lack of adequately trained staff, a regulatory bureaucracy which is slow and is (though the author delicately avoids the issue) prone to corruption, and a recent history of ethical scandals involving the use of unapproved drugs or the use of approved drugs for unapproved purposes. But nothing, the author suggests, that can't be smoothed over with a few IRB workshops, a few short-term benefits for study participants, and the "check is in the mail" notion of future general access to the tested medications.


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