FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.

CONCLUSION:: Sentinel infrastructure generated preliminary data that supported planning and implementation of a large pragmatic trial embedded in health plans. This planning identified unanticipated challenges that must be addressed in similar trials.
PMID: 30445835 [PubMed - as supplied by publisher]

Source: Clinical Trials - November 16, 2018 Category: Research Authors: Cocoros NM, Pokorney SD, Haynes K, Garcia C, Al-Khalidi HR, Al-Khatib SM, Archdeacon P, Goldsack JC, Harkins T, Lin ND, Martin D, McCall D, Nair V, Parlett L, Temple R, McMahill-Walraven C, Granger CB, Platt R Tags: Clin Trials Source Type: research