Emulating Randomized Clinical Trials With Nonrandomized Real-World Evidence Studies

© 2020 American Heart Association, Inc. BACKGROUND: Regulators are evaluating the use of noninterventional realworld evidence (RWE) studies to assess the effectiveness of medical products. The RCT DUPLICATE initiative (Randomized, Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology) uses a structured process to design RWE studies emulating randomized, controlled trials (RCTs) and compare results. We report findings of the first 10 trial emulations, evaluating cardiovascular outcomes of antidiabetic or antiplatelet medications.

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