Stopping Trials Early Due to Harm

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

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.

Publication types

  • Review

MeSH terms

  • Clinical Trials as Topic / ethics
  • Clinical Trials as Topic / methods
  • Early Termination of Clinical Trials*
  • Humans