Futility Assessment – ARCHIVED

CHAPTER SECTIONS

Data And Safety Monitoring

section 6

Futility Assessment – ARCHIVED

Contributors

Susan Ellenberg, PhD

Jeremy Sugarman, MD, MPH, MA

Doug Zatzick, MD

 

Contributing Editor

Gina Uhlenbrauck

Archived December 13, 2018 Go to Latest Version

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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SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction – Data and Safety Monitoring ARCHIVED
  2. Which PCTs Should Have a DMC? – ARCHIVED
  3. Monitoring Protocol Adherence – ARCHIVED
  4. Data Issues With Monitoring PCTs – ARCHIVED
  5. Monitoring for Serious Adverse Events – ARCHIVED
  6. Futility Assessment V. 2 – ARCHIVED
  7. Futility Assessment – ARCHIVED
  8. Case Study: Planning for Monitoring PCTs – ARCHIVED
  9. Including Stakeholder Perspectives – ARCHIVED
  10. Special Training and Resources for DMCs of Pragmatic Trials – ARCHIVED
  11. Additional Resources – ARCHIVED

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.

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Version History

Published August 25, 2017

current section :

Futility Assessment – ARCHIVED

  1. Introduction – Data and Safety Monitoring ARCHIVED
  2. Which PCTs Should Have a DMC? – ARCHIVED
  3. Monitoring Protocol Adherence – ARCHIVED
  4. Data Issues With Monitoring PCTs – ARCHIVED
  5. Monitoring for Serious Adverse Events – ARCHIVED
  6. Futility Assessment V. 2 – ARCHIVED
  7. Futility Assessment – ARCHIVED
  8. Case Study: Planning for Monitoring PCTs – ARCHIVED
  9. Including Stakeholder Perspectives – ARCHIVED
  10. Special Training and Resources for DMCs of Pragmatic Trials – ARCHIVED
  11. Additional Resources – ARCHIVED

Citation:

Ellenberg S, Sugarman J, Zatzick D. ARCHIVE Data and safety monitoring: Futility Assessment – ARCHIVED. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/ethics-and-regulatory/archive-data-and-safety-monitoring/futility-assessment/. Updated July 9, 2025. DOI: 10.28929/044.