ARCHIVE Data and safety monitoring
Section 9
Including Stakeholder Perspectives – ARCHIVED
As for any trial, the DMC should include an experienced statistician and medical experts from the setting being monitored.
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.
| Resource | Description |
|---|---|
| Building Partnerships and Teams 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 2013 | Study on participants’ perspectives on safety monitoring in clinical trials |
SECTIONS
sections
- Introduction – Data and Safety Monitoring ARCHIVED
- Which PCTs Should Have a DMC? – ARCHIVED
- Monitoring Protocol Adherence – ARCHIVED
- Data Issues With Monitoring PCTs – ARCHIVED
- Monitoring for Serious Adverse Events – ARCHIVED
- Futility Assessment V. 2 – ARCHIVED
- Futility Assessment – ARCHIVED
- Case Study: Planning for Monitoring PCTs – ARCHIVED
- Including Stakeholder Perspectives – ARCHIVED
- Special Training and Resources for DMCs of Pragmatic Trials – ARCHIVED
- Additional Resources – ARCHIVED
REFERENCES
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.
Flynn KE, Kramer JM, Dombeck CB, Weinfurt KP. 2013. Participants' perspectives on safety monitoring in clinical trials. Clin Trials. 10(4):552-559. doi:10.1177/1740774513484394.
current section : Including Stakeholder Perspectives – ARCHIVED
- Introduction – Data and Safety Monitoring ARCHIVED
- Which PCTs Should Have a DMC? – ARCHIVED
- Monitoring Protocol Adherence – ARCHIVED
- Data Issues With Monitoring PCTs – ARCHIVED
- Monitoring for Serious Adverse Events – ARCHIVED
- Futility Assessment V. 2 – ARCHIVED
- Futility Assessment – ARCHIVED
- Case Study: Planning for Monitoring PCTs – ARCHIVED
- Including Stakeholder Perspectives – ARCHIVED
- Special Training and Resources for DMCs of Pragmatic Trials – ARCHIVED
- Additional Resources – ARCHIVED