Stopping Trials Early Due to Harm.

Cook, Thomas; Buhule, Olive D · NEJM Evid · 2022

review · Level V

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Abstract

Stopping Trials Early Due to HarmDSMBs protect clinical trial participants from harm. We describe two trials stopped for potential harm to enrollees: a DSMB recommended termination soon after enrollment began when data showed higher mortality in the experimental versus the control arm, and a trial with completed enrollment was stopped while participants were being followed and treated.

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