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Pragmatic Guidance for Embedding Pragmatic Clinical Trials in Health Plans: Large Simple Trials Aren’t So Simple

    Basic Details

    There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results. Such trials can be large and efficient, using these data to identify trial-eligible patients and to ascertain outcomes.

    We use our experience primarily with the National Institutes of Health Pragmatic Trials Collaboratory Distributed Research Network, which comprises health plans that participate in the US Food & Drug Administration’s Sentinel System, to describe lessons learned from the conduct and planning of embedded pragmatic trials.


    Noelle M Cocoros, Jerry H Gurwitz, Mark J Cziraky, Christopher B Granger, Thomas Harkins, Kevin Haynes, Xiaojuan Li, Lauren Parlett, John D Seeger, Sonal Singh, Cheryl N McMahill-Walraven, Richard Platt

    Corresponding Author

    Noelle M Cocoros, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA