Friday, October 12, 2007

 

Clinical trials in the US

Businessworld

Gauri Kamath






The US is not doing enough to protect the safety of millions of human subjects of clinical trials, says a report by its department of health and human services. It estimates that between 2000 and 2005, the Food & Drug Administration (FDA) inspected only 1 per cent of clinical trial sites.

Worse, it found that the purpose of inspections was mostly to verify clinical trial data rather than ensure safety of trial participants. Even after problems were found, follow-ups by the FDA have been erratic.

Significantly, the FDA has inspected sites in India, too, when these are part of global trials for seeking marketing approval for a product in the US. In the absence of inspections by India’s drug regulator Drugs Controller General of India (DCGI), Indian companies have used successful FDA audits as proof of ethically-conducted trials.

The recent findings of the US department make this hard to swallow.

Shockingly, the US regulatory system has shortcomings similar to those in India, a fast emerging clinical trials destination. One, the US does not make it mandatory to register clinical trials except those on life-threatening illnesses. In India too, an online registry of trials was unveiled just this year, and registration is still voluntary.



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