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.
- 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
- Role of Stakeholder Perspectives
- Special Training and Resources for DMCs of Pragmatic Trials
- Additional Resources