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Grand Rounds June 2, 2023: PROACT Xa and The Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial (John Alexander, MD, MHS)

Rethinking Clinical Trials

The drugs were administered open label and all patients were given a low dose of aspirin. The study drug was mailed directly to participants, and at the end of the trial participants were instructed to destroy the drug. The trial took place at 64 sites, and randomized 863 patients. We never had an amendment to the protocol.