Pediatric study deaths called into question

September 4, 2008

The All India Institute of Medical Sciences (AIIMS) has reported 49 infants have died in clinical trials over the past two and a half years, but denies these were caused by investigational drugs, according to FDAnews.

The All India Institute of Medical Sciences (AIIMS) has reported 49 infants have died in clinical trials over the past two and a half years, but denies these were caused by investigational drugs, according to FDAnews.

The institute's Department of Pediatrics reportedly enrolled a total of 4,142 subjects since 2006, of whom 2,728 were younger than 12 months. The institute claims the deaths occurred due to pre-existing disease causes, although an Indian nongovernmental organization is calling for an investigation to gain further information about the trials.

The full FDAnews report can be found here.