The Data and Safety Monitoring Board: The Toughest Job in Clinical Trials

NEJM Evid. 2023 Feb;2(2):EVIDctw2200220. doi: 10.1056/EVIDctw2200220. Epub 2023 Jan 24.

Abstract

The DSMB: The Toughest Job in Clinical TrialsIn this review article, the authors discuss methods that DSMBs can use to compare the absolute and relative risks of benefits and adverse effects between trial interventions and illustrate how the DSMB can use this approach to evaluate the balance of these competing risks. Two approaches are discussed - the win ratio and the DOOR probability on one treatment relative to another.

Publication types

  • Review

MeSH terms

  • Clinical Trials Data Monitoring Committees*