Early Termination of Clinical Trials for Futility — Considerations for a Data and Safety Monitoring Board
Susan S. Ellenberg, Pamela A. Shaw
Abstract
Early Termination of Clinical Trials for FutilityClinical trials may be stopped for futility if there is little or no chance of demonstrating the hoped-for effect. Reasons include evidence of no treatment effect, substantial missing data that would unacceptably undermine trial conclusions, or event rates too low to support meaningful comparisons. This review examines issues faced by DSMBs in such settings.
Topics & Concepts
Clinical trialData monitoring committeeEvent (particle physics)Safety monitoringMedicinePsychologyIntensive care medicinePathologyBiologyQuantum mechanicsPhysicsBiotechnologyStatistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of LifeAssisted Reproductive Technology and Twin Pregnancy