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Only 2 percent of child drug trials have independent safety checks
Date:3/18/2008

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  • Death rates were highest in trials involving newborn babies, with 56 per cent of the 99 trials included reporting a death.

  • Other major specialities in which deaths were reported included infectious diseases, neurology, respiratory and kidney problems.

    Only papers published in English on the Medline database during the seven-year study period were included and the authors excluded studies that covered HIV and cancer because of high deaths rates from the actual diseases.

    Just over half of the studies compared a drug with a placebo dummy and a further 35 per cent involved a new medicine. A smaller percentage, 26 per cent, involved a direct comparison between two established drugs. Some of the trials included adults as well as children.

    Studies reporting severe drug toxicity problems came from a wide range of countries, including Argentina, Belgium, Canada, Chile, China, France, India, Israel, Italy, Japan, Netherlands, South Africa, Sweden, Taiwan, Thailand, Turkey, UK and the USA.

    Adverse drug reactions included bleeding, high blood pressure, seizures, psychosis, suicide, acute renal failure and death.

    The researchers stress that clinical drug trials in children are essential for the development of medicines and to provide evidence of the best treatments for specific conditions. But they feel that greater safety measures and awareness of the risk is essential.

    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.

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  • Contact: Dr. Helen Sammons
    helen.sammons@nottingham.ac.uk
    University of Nottingham
    Source:Eurekalert

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