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Review
. 2022 May;1(5):EVIDctw2100026.
doi: 10.1056/EVIDctw2100026. Epub 2022 Apr 26.

Stopping Trials Early Due to Harm

Thomas Cook  1 , Olive D Buhule  2
Affiliations
Review

Stopping Trials Early Due to Harm

Thomas Cook et al. NEJM Evid. 2022 May.

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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