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.
- Which PCTs Should Have a DMC?
- Monitoring Protocol Adherence
- Data Issues With Monitoring PCTs
- Monitoring for Serious Adverse Events
- Futility Assessment
- Case Study: Planning for Monitoring PCTs
- Including Stakeholder Perspectives
- Special Training and Resources for DMCs of Pragmatic Trials
- Additional Resources
- Futility Assessment – ARCHIVED