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FDA clinical trial diversity workshop reveals agency s expectations for sponsors | Hogan Lovells

On November 29 and 30, the U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative, hosted a public workshop on ways to increase the.

First RCT-DUPLICATE Findings Published in Circulation

Share this article Share this article NEW YORK, Dec. 17, 2020 /PRNewswire/  Real-world evidence (RWE) studies can offer comparable insights to randomized controlled trials (RCTs), particularly when the intent is to compare clinically meaningful treatment scenarios using rigorous study design and fit-for-purpose data, according to results from the RCT-DUPLICATE project published today in Circulation. Researchers from Brigham and Women s Hospital (BWH) and Harvard Medical School, in close collaboration with the U.S. Food and Drug Administration (FDA) and Aetion, reported the findings from 10 RWE studies designed to emulate RCTs for cardiovascular outcomes of antidiabetic or antiplatelet medications. Nine of the 10 RWE studies achieved at least two of three agreement metrics that researchers set at the outset. For each of these nine studies, the difference in results between the RWE and RCT was not statistically significant. Eight of the nine RWE findings achieved estimate agre

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