Healthy Skepticism Library item: 13349

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Publication type: news

Paediatric drug trials not being independently monitored
PM Live 2008 Mar 20
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=6578

Full text:

Researchers at the University of Nottingham in the UK have expressed concern about the level of independent monitoring of paediatric drug trials. In the April issue of the paediatric research journal Acta Pedriatrica a review has been published that states that only 2 per cent of trials are being overseen by independent safety monitoring committees. Child health researchers at the university analysed data from 739 international paediatric drug trials that were conducted between 1996 and 2000. Dr Helen Sammons, associate professor of child health at Nottingham university, said: “We feel that the small number of studies that reported having safety monitoring committees was unacceptable. “It is invaluable to have an independent monitor who can swiftly question any adverse drug reactions or differences in illness and death rates between groups taking part in clinical trials.” Only 74 per cent of the studies said that they had safety monitoring in place with only 13 studies reporting that independent experts oversaw their trials. Dr Sammons, lead author of the review in Acta, 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.” “We are calling for all paediatric drug trials to include independent safety monitoring committees to ensure that this vital work is carried in a way that minimises risks, and maximises benefits for the children taking part,” she added. The Association of the British Pharmaceutical Industry (ABPI) was keen to point out that in the case of small trail, where the decision to terminate or continue could be made with all the data present in one location, independent monitoring might not be needed. However, the ABPI recognises that in larger trials spread across various parts of the country, independent monitoring committees are an important part of collating data in order to determine the efficacy and safety of a paediatric drug. Richard Ley, spokesman for the ABPI, said: “Safety is an absolute priority or the pharmaceutical industry.” “This are is well covered by legislation. Any adverse drug reactions have to be reported within 15 days to the Medicines and Healthcare products Regulatory Agency (MHRA),” he added.