As for any trial, the DMC should include an experienced statistician and medical experts from the setting being investigated.
“Given the focus on patient-centered outcomes in PCTs, the role of a patient representative [on DMCs] may be particularly important” (Ellenberg et al. 2015).
Patient representatives can offer a unique and valuable perspective on the emerging risk-benefit profile during the trial. Other expertise that may be advisable include a biomedical informatician.
Resources for Integrating Stakeholder Perspectives
|How to Engage Stakeholders and Build Partnerships to Ensure a Successful Trial||Living Textbook chapter that describes best practices for engaging stakeholders in PCTs|
|What We Mean by Engagement||PCORI resource that includes tools and information for engaging patients and other stakeholders in research|
|Flynn et al. Clin Trials 2013||Study on participants’ perspectives on safety monitoring in clinical trials|
- 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