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NIH Collaboratory Workshop


Essentials of Embedded Pragmatic Clinical Trials


Program Description

This workshop introduced concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), with a particular focus on methods relevant to health services researchers. ePCTs are randomized trials conducted within health care systems that use streamlined procedures and existing infrastructure to answer important medical questions for patients, providers, and health systems. Such trials have the potential to inform policy and practice with broadly generalizable, high-quality evidence at lower cost and greater efficiency compared with traditional explanatory clinical trials. The workshop provided attendees with a greater understanding of the investigative opportunities for embedded health systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the NIH Health Care Systems Research Collaboratory Demonstration Projects supported and illustrated the topics presented.


Learning Objectives

  1. To clarify the definition of ePCTs and explain their utility.
  2. To provide greater understanding of the unique characteristics and challenges of designing, conducting, and implementing ePCTs within diverse health care systems.
  3. To increase the capacity of health services researchers to address important clinical questions with ePCTs.