The Impact of Landscape Changes on Data and Safety Monitoring Board Oversight of Clinical Trials

NEJM Evid. 2022 Sep;1(9):EVIDctw2100019. doi: 10.1056/EVIDctw2100019. Epub 2022 Aug 23.

Abstract

Impact of Landscape Changes on DSMB OversightThis Clinical Trials Workshop describes how external factors (or landscape changes) can affect monitoring of an ongoing clinical trial and discusses issues to consider to avoid stopping a trial too early while maintaining equipoise for enrolled participants. Three clinical trials in which DSMBs had to consider the effects of landscape changes on the continued performance of the monitored trial are reviewed.

Publication types

  • Review

MeSH terms

  • Clinical Trials Data Monitoring Committees*
  • Humans