Futility Assessment V. 2 – ARCHIVED

CHAPTER SECTIONS

ARCHIVE Data and safety monitoring


Section 7

Futility Assessment V. 2 – ARCHIVED

Contributors

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.

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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

July 3, 2020: Minor corrections to layout and formatting (changes made by D. Seils).

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

current section :

Futility Assessment V. 2 – 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 V. 2 – 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-assessmentv2/. Updated July 9, 2025. DOI: 10.28929/108.