[19 March 2008] - 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 in the United Kingdom found that under 2 per cent 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 per cent, 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.
"It is essential that appropriate drugs are developed for use in children and clinical trials need to continue. They are vital because they increase the chance of picking up adverse reactions before drugs are introduced into general clinical practice."
The team found that children experienced adverse effects caused by the drugs in a third of the trials - nearly 37 per cent. In 11 per cent, side-effects were moderate or severe and even sometimes life-threatening. Sammons stressed that the point of a trial was to find out whether the benefits of the drug outweighed any side-effects before the drug was used in the population at large.
"In the past drugs have gone into the marketplace without trials and we have picked up the side-effects later," she said. Until a few years ago drugs were rarely tested or licensed for use in children. Doctors had no alternative but to use adult medicines, guess at the appropriate dose and hope they worked the same way in children. But, said Sammons, children were not small adults. "The assumption is if it's fine in adults, it will be fine in children, but the child has a different metabolism," she said.
The study found that in seven out of 10 trials adverse events were reported.
These included bleeding, high blood pressure, seizures, psychosis, suicide and acute renal failure, but in most cases they were not thought to be caused by the drug. In 11 per cent of the trials there were deaths, but most were also not thought to be related to the drug.
Deaths were highest in trials involving premature babies - who are often very sick. There were also deaths in trials of drugs for infectious diseases, neurology, and respiratory and kidney problems.
- WHO: Promoting Safety of Medicines for Children (24 September 2007)
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Last updated 19/03/2008 06:22:11