Independant safety monitoring 'lacking' in child trials
levels that are "unacceptable," according to a new analysis.
Only 2 per cent - one in every 50 - paediatric drug trials currently use independent safety committees to monitor adverse events, despite the fact that 74 per cent claim to perform safety monitoring. The worrying reality was uncovered during an analysis by researchers a The University of Nottingham of 739 international drug trials published between 1996 and 2002. "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 lead author Dr Helen Sammons, Associate Professor of Child Health. "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 number of paediatric drug trials conducted in the European Union is likely to rise after new legislation was introduced that offers companies a financial incentive to do so, in the form of a six-month extension to their exclusive drug manufacturing licence if children are included in the clinical studies. Similar legislation has been in place in the USA for over five years and has led to an increase in drug trials that include children. "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," said Dr Sammons. "But we feel that the small number of studies that reported having safety monitoring committees was unacceptable. It is invaluable to have an independent monitor who can swiftly question any adverse drug reactions or differences in illness and death rates between groups taking part in the clinical trials". Indeed, of the 13 trials that did have independent monitoring committees, six (almost half) were terminated early because of significant drug toxicity. But overall, seven out of ten trials reported adverse events but only a fifth of the trials reported a serious adverse event (an untoward medical occurrence, not necessarily related to a drug), while adverse drug reactions were reported in just under 37 per cent of trials, with 11 per cent of trials reporting moderate or severe adverse drug reactions. The review, titled "Safety in paediatric clinical trials - a 7 year review", was published in the April 2008 issue of the journal Acta Paediatrica.