title: Establishing causality in the assessment of safety of medicines for children.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK. d.ashby@qmul.ac.uk
authors.forename: Deborah
authors.initials: D
authors.lastname: Ashby
mesh_terms: D015984:Causality; D002648:Child; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000188:drug therapy; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D019317:Evidence-Based Medicine; D006801:Humans; D010372:Pediatrics / Q000592:standards*; D017891:Pharmacoepidemiology; D055553:Prescription Drugs / Q000592:standards* / Q000633:toxicity*; D016896:Treatment Outcome
chemical_list: D055553:Prescription Drugs