Including Stakeholder Perspectives

Data and Safety Monitoring

Section 8

Including Stakeholder Perspectives


Susan Ellenberg, PhD

Jeremy Sugarman, MD, MPH, MA

Doug Zatzick, MD


Contributing Editor

Gina Uhlenbrauck

Liz Wing, MA

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.


Resources for Integrating Stakeholder Perspectives

Resource Description
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





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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.

Version History

December 13, 2018: Revised the title of this section (changes made by L. Wing).

Published August 25, 2017


Ellenberg S, Sugarman J, Zatzick D. Data and Safety Monitoring: Including Stakeholder Perspectives. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated September 12, 2019. DOI: 10.28929/046.