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FDA expands RWE demonstration project

Written by Admin | Apr 10, 2019
The FDA and Brigham and Women's Hospitals are expanding the RCT DUPLICATE demonstration project to predict the results of seven ongoing Phase IV trials using real-world evidence (RWE). The Aetion Evidence Platform® is used for analytics, and the program aims to identify situations where RWE can provide estimates of treatment safety and efficacy for supplemental new drug applications.

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