38 trial deaths in India in 2 years but SAE reporting overkill skewing data
This article was originally published in Scrip
India has reported 38 deaths due to clinical trials in 2010 and 2011, less than 5% of the overall deaths in the country during such studies, with compensation having been paid in all but one case each year. The data are significant since they lend some credence to industry's claims that India's excessive reporting requirements for serious adverse events may be skewing clinical trial data in the country.
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