Establishing causality in the assessment of safety of medicines for children


  • Invited Review article for Acta Paediatrica, based on talk to European Society for Paediatric Research, Prague, October 2007.

  • On 1 October 2008, Deborah Ashby will join as Professor of Medical Statistics and Clinical Trials, Division of Epidemiology, Public Health and Primary Care, Faculty of Medicine, Imperial College London, Norfolk Place, London W2 1PG, UK.

Prof. Deborah Ashby, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, Wolfson Institute for Preventive Medicine, Charterhouse Square, London, EC1M 6BQ UK.
Tel: +44 20-7882-6264 |
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Background: Data on safety of medicines in children typically arises from various sources, rendering assessment of causality challenging.

Methods: We outline these sources, together with their strengths and weaknesses. Bradford Hill proposed criteria for assessment of causality of observed associations; we explore their utility in this context.

Conclusion: Collaborations between clinicians, epidemiologists and clinical pharmacologists, making intelligent use of both older and newer methodologies, can help make the use of medicines in children safer.