The Lancet attacks "cavalier" child clinical trial practices

An editorial in The Lancet has questioned whether "participants in clinical trials should receive more cavalier treatment than airline passengers?" In particular, the article claims that drug industry practices regarding pediatric clinical trials do not go far enough in ensuring the volunteer's safety, a charge dismissed by the Association of the British Pharmaceutical Industry.

The issue was raised by a paper which appeared in the Acta Paediatrica journal, written by researchers from the University of Nottingham, UK. The authors carried out a detailed analysis of 739 international clinical trials involving children from 1996 to 2002. Of these, only 13 or 2%, had safety monitoring committees.

Helen Sammons, who lead the research and an associate professor at the University's Academic Division of Child Health, said: "we were very surprised by the low level of trials that had independent safety monitoring committees and are urging pharmaceutical companies to include these in all future trials involving children."