BioCentury
ARTICLE | Politics & Policy

NIH confirms some clinical trials halted in India

July 16, 2013 11:51 PM UTC

NIH confirmed in a statement to BioCentury that some agency-sponsored trials in India have stopped enrollment while others have been postponed as a result of new clinical trial regulations issued in India. The agency did not provide details. According to clinicaltrials.gov, there are at least 34 open NIH-funded clinical trials in India, including 12 trials for HIV infection and three trials for tuberculosis. NIH said it "hopes that future changes will enable studies to resume."

The new regulations require clinical trial sponsors to provide compensation to patients who suffer injury or death during or as a result of the trial, including as a result of the "failure of investigational product to provide intended therapeutic effect" (see BioCentury Extra, Feb. 12). ...