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Rare adverse events in clinical trials: understanding the rule of three
  1. Igho J Onakpoya
  1. Nuffield Department of Primary Care Health Sciences, University of Oxford, Centre for Evidence-Based Medicine, Oxford, UK
  1. Correspondence to Dr Igho J Onakpoya, Nuffield Department of Primary Care Health Sciences, University of Oxford, Centre for Evidence-Based Medicine, Oxford OX2 6GG, UK; igho.onakpoya{at}phc.ox.ac.uk

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Investigators should report rare and very rare adverse events in clinical trials. Even though they may not give a signal in any single trial, a meta-analysis could reveal potentially important drug–adverse event associations that might require further verification. Data from a meta-analysis of such rare events can shorten the time to decision-making by regulatory agencies and/or drug manufacturers, especially in cases where the reported harms are severe.

The benefit-harm profiles of new medicines are usually not fully known at the time of regulatory approval. …

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