passage-69
abstract
Establishing causality in the assessment of safety of 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.