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Using real-world data, the FDA aims to predict randomized trial results before they’re done
The US Food and Drug Administration (FDA) is expanding its real-world evidence (RWE) program with Aetion and Brigham and Women’s Hospital. The RCT DUPLICATE initiative, mandated by the 21st Century Cures Act, originally aimed to replicate the results of 30 completed randomized clinical trials (RCTs) using RWE, but will now predict the outcomes of seven ongoing Phase IV trials as well.
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