Invited Review article for Acta Paediatrica, based on talk to European Society for Paediatric Research, Prague, October 2007.
Establishing causality in the assessment of safety of medicines for children
Article first published online: 12 SEP 2008
©2008 The Author/Journal Compilation ©2008 Foundation Acta Pædiatrica/Acta Pædiatrica
Volume 97, Issue 12, pages 1611–1616, December 2008
How to Cite
Ashby, D. (2008), Establishing causality in the assessment of safety of medicines for children. Acta Paediatrica, 97: 1611–1616. doi: 10.1111/j.1651-2227.2008.01026.x
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.
- Issue published online: 6 NOV 2008
- Article first published online: 12 SEP 2008
- Received 12 June 2008; revised 12 August 2008; accepted 14 August 2008.
- Bradford hill criteria;
- Evidence synthesis;
- Medicines for children;
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.