Futility Assessment

Data and Safety Monitoring

Section 6

Futility Assessment


Susan Ellenberg, PhD

Jeremy Sugarman, MD, MPH, MA

Doug Zatzick, MD


Contributing Editor

Gina Uhlenbrauck

Liz Wing, MA

A thorough discussion of the arguments for and against early termination for futility in ePCTs has been published elsewhere (Ellenberg et al. 2015). An important consideration is that when treatments in common use are studied, as is generally the case in ePCTs, particularly strong evidence may be needed to persuade clinicians of the reliability of the results. Clinicians accustomed to administering a particular therapy may not be convinced that another therapy is as effective when the trial is small. Further, if both treatments are in common use, there should be no ethical concern about continuing a study even when it appears that the effects of the treatments are similar. Additionally, even small differences in outcomes may be informative in some cases when treatments are widely used. DMCs and sponsors should work together to determine thresholds for early termination of a trial before trial startup.




back to top

Ellenberg SS, Culbertson R, Gillen DL, Goodman S, Schrandt S, Zirkle M. 2015. Data monitoring committees for pragmatic clinical trials. Clin Trials. 12:530–536. doi:10.1177/1740774515597697.

Version History

December 13, 2018: Updated description of futility assessment as part of annual content update (changes made by L. Wing).

Published August 25, 2017- Version 1 Archived


Ellenberg S, Sugarman J, Zatzick D. Data and Safety Monitoring: Futility Assessment. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/design/planning-data-safety-monitoring/futility-assessmentv2/. Updated January 18, 2019. DOI: 10.28929/108.