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The Globalisation of Paediatric Research

THE PROBLEM

Concerned that there is insufficient investment in clinical trials and the development and manufacture of medicines for children, organisations like the World Health Organization (WHO), the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) are trying to stimulate clinical research in children and encourage the conduct of ethical, high quality clinical trials to facilitate the timely licensing of appropriate, high quality medicines with appropriate formulations.

Several problems exist in the use of medicines for children. Most medicines given to children have been used off-label (1). In hospital paediatric wards, this is around 45 per cent, and in the neonatal intensive care setting this can be as high as 90 per cent (2). Over the counter, traditional and herbal medicines are available, although their use is often not evidence-based. Commonly, this experience, based principally on simple extrapolation from the use of medicines in adults, is rarely incorporated into clinical practice guidelines or medicinal product labelling. Additionally, counterfeit and substandard medicines are widespread, and although innovative medicines are available with paediatric labelling, often long-term benefit or risk has not been established. These practices represent a potential safety hazard to children in the form of adverse events through overdosing, inefficacy through underdosing, and the use of inappropriate formulations or substandard medicines.


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Philippa Smit-Marshall is a UK-qualified physician and pharmacologist with 20 years’ experience in the pharmaceutical industry. She is currently Vice President of Medical Affairs for Europe and Asia Pacific at PharmaNet and is responsible for providing medical support to clinical studies conducted in those regions. At PharmaNet, she also provides consulting support to clients on development planning, regulatory submissions and evaluation of drug candidates, including drugs for paediatric use. Her therapeutic areas of interest include paediatrics, cardiovascular medicine, endocrinology and neurology. She is Chairman of the Institute of Clinical Research’s Special Interest Group on Paediatrics and a member of the European Contract Research Organisation’s Working Party on Paediatrics.
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