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Lack of safety monitoring in paediatric drug trials

By Nigel Praities

GPs should be aware of the risk of unrecognised adverse reactions in children because of serious systematic failures in the way paediatric drug trials are run, researchers warn.

Children's health may be put at risk by lax monitoring of safety in paediatric clinical trials of drugs, say UK researchers.

The claim comes after an analysis of nearly 740 clinical trials in children from 1996-2002 showed while 71% reported adverse events in their trials, only 2% used independent monitoring committees to look at safety.

The authors said this lack of impartial scrutiny meant adverse reactions take longer to be recognised and may only be spotted by GPs when they are used in routine care.

Professor Helen Sammons, lead author of the study and a paediatric consultant at Derbyshire Children's Hospital, said rigorous safety monitoring in paediatric trials was crucial to spot problems early.

‘If a drug just goes into routine practice universally then it can take a lot longer to pick up adverse reactions as there is such a wide spread of the population. What we don't want is another Seroxat or thalidomide. We want to pick these drugs out in trials before they get into the general population,' she said.

Professor Sammons recommended GPs should check if trials use safety monitoring committees before advising parents about clinical trials or enrolling children.

Dr Bill Beeby, a GP in Middlesbrough and chair of the GPC clinical and prescribing subcommittee, said the authors' conclusion that safety committees should monitor any trials involving children for adverse events was ‘very sensible'.

‘Children are not just small adults and there are significant risks in using treatments "off licence" by extrapolating data from drug trials in the adult population,' he said.

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