Tuesday, December 16, 2008

Child Death Rate in Outsourced Clinical Trials in India

This post on InjuryBoard.com highlights how 49 children involved in clinical trials in India have died since 2006. Dr. Vinod K. Paul, the head of pediatrics the All India Institute of Medical Sciences, mentions that all these children have died from serious illnesses and not the nature of the clinical drug trials itself.

Still there is some concern that many illiterate, poor families who do not speak English sign contracts written by foreign lawyers without understanding the nature of the clinical drug trials. Other hazardous problems include the lack of inspections at the factories and fraudulent clinical trial data.

Most companies are turning to foreign countries because of fewer restrictions, and where patients don’t fully understand but sign consenting documents anyway. What are your thoughts?

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