In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.

Authors Caleigh Propes, Kayla Mehl, and Stephanie Morain review early experiences with pragmatic trials and describe the challenges researchers face in achieving representative enrollment:

• Pragmatic trials are embedded in unjust healthcare systems
• Pragmatic trials often rely on electronic health record systems for data collection
• As in traditional clinical trials, site selection in pragmatic trials tends to be biased toward better-resourced sites and sites with closer ties to established researchers
• There is a general lack of attention to health equity considerations in trial design

The authors conclude that “further empirical scholarship is needed to assess the extent to which [pragmatic trials] are (or are not) truly representative and to define appropriate enrollment goals.”

Read the full article.

Propes is a doctoral student in bioethics and health policy and management at the Berman Institute of Bioethics, Mehl is a postdoctoral fellow in the ethics and regulatory aspects of pragmatic clinical trials at the Berman Institute, and Morain is a core faculty member at the Berman Institute and an associate professor of health policy and management at the Bloomberg School of Public Health—all at Johns Hopkins University.