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Drug Trials Involving Kids Need More Monitoring

Mar 19, 2008 | Parker Waichman LLP

Drug clinical trails involving children don't get enough scrutiny, a new study says.  According to experts at Great Britain’s University of Nottingham, the method and processes in which drug trials are conducted in children require more and stricter monitoring and more needs to be done to ensure the children’s.  In a study of 739 trials, only a very small percentage—two percent—had any type of independent safety monitoring committees.  The remainder studied only relied on internal monitoring.  The University of Nottingham researchers studied just those trials that were funded by the pharmaceutical industry, government bodies, and charities.

The Acta Paediatrica journal reported the University of Nottingham team reported that these sorts of monitoring of the testing methods were "unacceptable."  The researchers also said that independent oversight was necessary.  Unfortunately, industry officials disagreed, saying there were already strict rules in place.  All drug trials monitor safety; most conduct monitoring through internal processes.  In Great Britain’s European Union, these processes have to be reported to drug regulators within 15 days.  Procedures similar to these must be followed in other parts of the world.

The Nottingham team also found that adverse drug reactions, including bleeding, high blood pressure, and seizures, were reported in just over a third of those patients involved in the trials studied.  It was also found that trials utilizing independent monitoring committees were more likely to be terminated early in the event of problems such as adverse reactions.  In total, six trials were ended and all six that were ended early had the oversight of independent committees.  The researchers said they would not expect the findings have any different results for those trials involving adults.

Dr. Helen Sammons, lead researcher with the Nottingham team and a professor in child health, said, "We feel that the small number of studies that reported having safety monitoring committees was unacceptable.”  Sammons agrees with the benefits provided by independent committees saying, "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.”  Speaking in terms of parents and their knowledge of what occurs in trials geared to children she said, "Parents also need to be made aware of the risks of adverse drug reactions when a child takes any medicine so that they can make informed decisions that balance those risks against the possible benefits the drug may provide their child."

Great Britain’s Association of the British Pharmaceutical Industry—a company which represents drug firms—disagreed saying procedures currently in place were adequate.  A spokesman for the group was said, "Safety is already strictly governed.  The independent committees are really only need in large scale trials conducted across a number of sites."

Meanwhile, the Medicines for Children Research Network has been established in England by the Department of Health and comprises six local research networks and will have the potential to recruit children to carry out clinical studies on drugs—new chemical entities and those already used off-label or unlicensed—to children. Simultaneously, the European Medicines Agency is coordinating European networks for research on drugs for children.  The option for third-party oversight safety committees was not discussed.


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