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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. …
Contributors IJO was involved with the conceptualisation and writing of the manuscript.
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.