Early Termination of Clinical Trials for Futility - Considerations for a Data and Safety Monitoring Board

Overview

Journal NEJM Evid

Specialty General Medicine

Date 2024 Feb 6

PMID 38319261

Authors

Susan S Ellenberg

Pamela A Shaw

Affiliations

Soon will be listed here.

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.

Citing Articles

TAD-SIE: sample size estimation for clinical randomized controlled trials using a Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator.

Lala S, Jha N Trials. 2025; 26(1):31.

PMID: 39881374 PMC: 11780961. DOI: 10.1186/s13063-024-08661-1.

Inside the Mind of the DMC: A Review of Principles and Issues with Case Studies.

Ge L, Hamasaki T, Evans S Ther Innov Regul Sci. 2024; 59(2):234-244.

PMID: 39688768 DOI: 10.1007/s43441-024-00720-8.

Randomised clinical trial of a 16 mg vs 24 mg maintenance daily dose of buprenorphine to increase retention in treatment among people with an opioid use disorder in Rhode Island: study protocol paper.

Armeni K, Chambers L, Peachey A, Berk J, Langdon K, Peterson L BMJ Open. 2024; 14(11):e085888.

PMID: 39521460 PMC: 11551980. DOI: 10.1136/bmjopen-2024-085888.

Effect of Disulfiram and Copper Plus Chemotherapy vs Chemotherapy Alone on Survival in Patients With Recurrent Glioblastoma: A Randomized Clinical Trial.

Werlenius K, Kinhult S, Solheim T, Magelssen H, Lofgren D, Mudaisi M JAMA Netw Open. 2023; 6(3):e234149.

PMID: 37000452 PMC: 10066460. DOI: 10.1001/jamanetworkopen.2023.4149.