Mar 20

· Research highlights adverse effects of tests
· ‘Surprise’ at lack of monitoring committees

Only a tiny minority of drug trials on children have an independent safety monitoring committee to pick up potentially dangerous side-effects, a study has revealed.Researchers from Nottingham University found that under 2% of the 739 international drug trials published between 1996 and 2002 had such committees of independent experts who would scrutinise data and warn, if necessary, that it was not safe to carry on.

Among the 2%, six trials had to be stopped early because of toxic effects on the child patients.

“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,” said Dr Helen Sammons, associate professor of child health at Nottingham and lead author of the paper, published in the child health journal Acta Paediatrica. Continue reading »

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