What is a Pragmatic Clinical Trial?
Section 6
Key Considerations for Pragmatic Trials
Planning a pragmatic clinical trial embedded in healthcare systems often requires different approaches to study design, engagement with participants and research partners, study startup, data collection, data analysis, regulatory and ethical oversight, and dissemination than traditional explanatory trials (O’Rourke et al 2015). To provide expertise and support to the NIH Collaboratory Trials, the Coordinating Center established several Core Working Groups to assist study teams as they navigate from planning to implementation to dissemination. The webpage for each Core listed below provides information and links to multiple resources, including webinars, publications, and white papers that reflect the knowledge, insight, and best practices acquired by the Cores in collaboration with the NIH Collaboratory Trials.
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REFERENCES
O’Rourke PP, Carrithers J, Patrick-Lake B, et al. 2015. Harmonization and streamlining of research oversight for pragmatic clinical trials. Clin Trials. 12:449–456. doi:10.1177/1740774515597685. PMID: 26374678.
ACKNOWLEDGMENTS
Contributing editors of previous versions of this chapter include Jonathan McCall, Karen Staman, and Liz Wing of the NIH Pragmatic Trials Collaboratory Coordinating Center.