You are here

Article Text

Article menu
Download PDFPDF
EBM opinion and debate
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

https://doi.org/10.1136/ebmed-2017-110885

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    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. …

    View Full Text

    Footnotes

    • Contributors IJO was involved with the conceptualisation and writing of the manuscript.

    • Competing interests None declared.

    • Provenance and peer review Commissioned; internally peer reviewed.