Special Training and Resources for DMCs of Pragmatic Trials

Data and Safety Monitoring

Section 9

Special Training and Resources for DMCs of Pragmatic Trials

Contributors

Susan Ellenberg, PhD

Jeremy Sugarman, MD, MPH, MA

Doug Zatzick, MD

 

Contributing Editor

Gina Uhlenbrauck

The nature of PCTs is such that DMCs could benefit from having representation from a statistician with knowledge of cluster randomized designs and the intracluster correlation coefficient. Training for all DMC members on the particular issues of monitoring PCTs is also expected to be helpful. As some PCTs have experienced, determining a feasible and acceptable data monitoring plan can be a major barrier to getting a PCT through the planning phase (see SPOT investigator interview). As described throughout this chapter, some typical monitoring practices used for traditional trials may need to be rethought when applied to PCTs. The NIH Collaboratory plans to develop training resources that can be used to educate DMCs on the intricacies of monitoring PCTs. Until such training is available, the investigator may need to expend extra effort holding open discussions with the sponsor and DMC during the planning phase to reach a satisfactory monitoring plan.

The NIH Collaboratory Regulatory/Ethics Core has developed a DMC charter template that can be used for PCTs. A charter defines the primary responsibilities of a DMC, its membership, the purpose and timing of its meetings, and its procedures and statistical monitoring guidelines. A charter customized for PCTs may include specific requirements, such as the need for at least one DMC member to have prior experience in conducting and interpreting data from PCTs.

Data monitoring for PCTs is evolving, as more PCTs are conducted and more is learned about special issues that might need to be considered. The Living Textbook will continue to be updated as new information emerges.

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Citation:

Ellenberg S, Sugarman J, Zatzick D. Data and Safety Monitoring: Special Training and Resources for DMCs of Pragmatic Trials. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://rethinkingclinicaltrials.org/design/planning-data-safety-monitoring/special-training-and-resources-for-dmcs-of-pragmatic-trials/. Updated September 26, 2017.