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20 Mar 2008
Clinical trials by pharmaceutical industries, government bodies and charities involving children should undergo increased independent safety scrutiny, a report claims.
A study of 729 trials by researchers at Nottingham University found only two per cent had set up independent safety monitoring committees.
The remainder of trials used internal monitoring systems with adverse reactions to treatments reported to regulators by law.
Some 36.5 per cent of trials reported adverse drug reactions, six per cent reported moderate reactions and five per cent reported severe reactions.
Six trials with safety monitoring committees were terminated early as a result of "significant" adverse drug reactions (ADRs) including acute renal failure, bleeding, high blood pressure, psychosis, seizures and suicide.
"There were deaths in 83 (11 per cent) trials. In the majority of trials, mortality was thought to be unrelated to the investigational drug," the paper adds.
However, the Association of the British Pharmaceutical Industry has dismissed the claims, stating that safety of trials on paediatric participants is "already strictly governed".
A spokesperson for the body told the BBC that independent committees are required only in large scale trials that are conducted over multiple sites.
Findings from the trials carried out in countries including Argentina, Belgium, Canada, Chile, China, India and the UK, are reported in the child health journal Acta Paediatrica.
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