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Indian Trial Conductor Reports 49 Infant Deaths Since 2006

This article was originally published in PharmAsia News

Executive Summary

An Indian medical group has acknowledged at least 49 babies have died while participating in clinical drug trials over the past two and one-half years. Many of the infants were under one year of age, according to a report released by the All India Institute of Medical Sciences. AIIMS said 4,142 babies were enrolled for clinical trials and 49 of them have died since Jan. 1, 2006 while in one of the 42 sets of trials conducted with babies. AIIMS said the mortality rate was 1.18 percent and the trials tested five foreign-made drugs, including zinc tablets, almesartan, valsartan, rituximab and gene-activated human glucocerebrosidase. (Click here for more



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