Futility Assessment

Data and Safety Monitoring

Section 6

Futility Assessment

Contributors

Susan Ellenberg, PhD

Jeremy Sugarman, MD, MPH, MA

Doug Zatzick, MD

 

Contributing Editor

Gina Uhlenbrauck

A thorough discussion of the arguments for and against early termination for futility in PCTs has been published elsewhere (Ellenberg et al. 2015). Briefly, considerations include that complete and overwhelming evidence showing lack of effect may be more persuasive to clinicians, especially when a PCT is studying practices that are already in common use. Similarly, 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.

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REFERENCES

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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.

Citation:

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: http://rethinkingclinicaltrials.org/design/planning-data-safety-monitoring/futility-assessment/. Updated August 24, 2017.