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Published on 19 March 2008

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Child drug trial safety test call

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Researchers have said that drug trials which involve children should be subject to independent safety checks.

A team from the medical school at the University of Nottingham reviewed 739 such studies and found that just 2% had independent safety monitoring committees in place to look for things like adverse reactions to medicines.

The experts discovered that the rest relied on internal monitoring systems, which is standard practice across the industry, with any adverse reactions reported to the relevant regulator by law.

But the authors of the study said they would like to see more independence in the system.

Lead author Dr Helen Sammons, an associate professor of child health, said: “We need to test drugs on children as the only other options are to use unlicensed drugs or prescribe drugs that have been licensed for adults off label – outside the terms of their licence.

“But we feel that the small number of studies that reported having safety monitoring committees was unacceptable.”

A spokesman for the Association of the British Pharmaceutical Industry (ABPI) said: “Safety is paramount in the pharmaceutical industry, especially with trials on children.

“It’s down to the sponsor of the clinical trial whether they want to have data safety monitoring boards.”

Copyright © PA Business 2008

Association of the British Pharmaceutical Industry



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