December 8, 2017: Data and Safety Monitoring in Pragmatic Clinical Trials


Greg Simon, MD, MPH
Senior Investigator
Kaiser Permanente Washington Health Research Institute

Jeremy Sugarman, MD, MPH, MA
Harvey M. Meyerhoff Professor of Bioethics and Medicine
Johns Hopkins Berman Institute of Bioethics

Susan S. Ellenberg, PhD
Professor of Biostatistics
Professor of Medical Ethics and Health Policy
Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania


Data and Safety Monitoring in Pragmatic Clinical Trials


Pragmatic clinical trial; Safety monitoring; Data monitoring committee; Data and safety monitoring board; DSMB; Patient privacy; Research ethics

Key Points

  • An external approach to monitoring can yield usable results, guard trial integrity, and also ensure patients aren’t exposed to undue risk.
  • A Data Safety and Monitoring Board (DSMB) panel of expertise is not set in stone, so an ethicist, a patient advocate, or a sponsor representative could make valuable additions.
  • There are special issues needing monitored in pragmatic trials including protocol adherence, eligibility, and subjective study outcomes.
  • Privacy concerns may prevent merging data from multiple electronic health record systems at one central site; therefore, quality control across sites is crucial to assure analyses are conducted identically.

Discussion Themes

Emerging experiences and data can pose ethical quandaries for investigators in meeting their obligations to minimize risk to participants, which is why monitoring is so crucial.

Since pragmatic trials will typically be addressing questions intended to impact health practices, an expert oversight group will be important for most PCTs.

A DSMB typically considers monitoring study quality as one of its mandates, and may be uncomfortable making recommendations based on observed treatment effects without a sense of how effectively interventions are being administered.

For More Information

For information on Data & Safety Monitoring for #pragmatictrials, visit the Living Textbook #pctGR


@PCTGrandRounds, @Collaboratory1, @GregSimonKPWHRI, @KPWaResearch, @JohnsHopkinsSPH, @UPenn_MedEthics, #DataSafety, #PatientAdvocate, #Pragmatictrials, #EHR, #Qualitycontrol, #AdverseEvents #pctGR