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FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials
The FDA, in collaboration with Brigham and Women's Hospital and Aetion, is conducting a pilot project to assess whether real-world evidence (RWE) can accurately predict the outcomes of ongoing randomized clinical trials, potentially revolutionizing the drug approval process by substituting lengthy and expensive trials with existing patient data, with interim results expected by mid-2020 and full results by the end of the year.
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