= Independent trial safety monitoring
Independent trial safety monitoring reviews accumulating serious outcomes according to a prespecified plan and may recommend stopping or modifying a <clinical trial> when harm or benefit changes the ethical balance. Complete ascertainment of deaths and other severe outcomes is needed even if the trial is sized for a different endpoint. Pooled evidence and prespecified sequential thresholds can make rare-event monitoring useful without presenting a nonsignificant harm comparison as safety.
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