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This one-day Workshop will explore challenges and strategies for planning and implementing embedded pragmatic clinical trials (PCT) that compare two or more therapeutic medical regimens. Pragmatic trials differ from traditional clinical trials, as they test interventions or practices delivered in real-world settings. If conducted within integrated health care systems, embedded PCT can leverage existing infrastructure to answer important clinical questions in a cost-effective manner. They can also bridge the critical gap between clinical evidence, practice and policy in health care delivery.
The NIH Health Care Systems Research Collaboratory, an NIH Common Fund initiative, has launched a set of PCT in partnership with several US health care systems. These trials have served as case studies for addressing challenges of pragmatic research; and the program has developed an extensive set of methods and best practices for embedded PCT. There is considerable interest, however, in expanding the interventions tested within the Collaboratory, specifically for developing additional tools and strategies that test distinct therapeutic medical interventions – A vs. B trials.
The Workshop will include a series of moderated discussions of opportunities and approaches for partnering with health care systems, and other stakeholders, to conduct embedded A vs. B trials. Ongoing A vs. B trials in the US will be presented as potential models for future studies. In view of the diversity of health care systems and delivery in the US, different design and analytic strategies for these trials will also be presented. As regulatory oversight of the clinical research enterprise is an essential component of PCT planning and implementation, the Workshop will also discuss regulatory aspects, including ethical oversight, of trials that test such interventions. The Workshop aims to inform stakeholders on progress in pragmatic A vs. B trials, and to explore strategies for expanding future research opportunities.