Pragmatic clinical trials (PCTs) are purposely designed to answer important questions relevant to clinical decision-making in routine healthcare settings, which may include clinics, hospitals, or healthcare systems. The conduct of a PCT proceeds from the intervention’s design, beginning with the concrete planning of all the study elements in the trial. For study teams, conducting a PCT will typically involve activities at multiple levels within a healthcare system—from engaging diverse stakeholders at both the leadership and frontline staff levels to working with operational personnel to modify the electronic health record (EHR). A given trial’s implementation may be complex and require specialized training of operational staff while also ensuring a smooth integration into the existing clinical workflow.
This section of the Living Textbook is intended to help study teams navigate the myriad logistical and methodological challenges of conducting a PCT. It describes concepts, tasks, tools, and external resources for trial planning and readiness, execution, analysis, and study close-out. Where useful, we link to scenarios and lessons learned from the NIH Collaboratory’s Demonstration Projects and other embedded PCT experiences.