While informed consent and fastidious data capture are important in clinical trials everywhere, they are now perhaps even more so in India, where the nation's drug controller general is expected to propose penal provisions for clinical research misconduct, following the 462 trial volunteer deaths counted through June.
The action comes as India continues to enjoy big-pharma and big-CRO interest in conducting trials there. Some experts estimate that it is as much as 60 percent cheaper to conduct trials there than in the U.S.
Data from India's Union Health Ministry tell the story. The 462 deaths through June mark a pace that will exceed the 637 deaths of last year, reports Indian Express. And it already exceeds the 288 and 132 deaths for the full years 2008 and 2007, respectively.
The ministry says the deaths may be due to disease-related reasons or unrelated causes, rather than trial participation itself. But a case in which four girls died after vaccination during the trial of a human papilloma virus (HPV) prophylactic fuels the fire. It's still being investigated and officials have halted the trial.
India has granted permission for about 250 trials in the first half of 2010--117 for international companies and 134 for local drugmakers. That's slightly ahead of pace compared with the 453 total trials of 2009, but roughly on par with 2008's 521 trials.
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