The RWE Regulatory Evolution

Real-world evidence (RWE) has had increased impact on the development and commercialization of new treatments. Now, the FDA, prompted by the 21st Century Cures Act, is engaged in a multi-year process to determine exactly how RWE can augment or even substitute randomized clinical trials (RCTs), to get the right treatment to the right patient faster and safely.
 
As part of this commitment, Brigham and Women’s Hospital, Harvard Medical School, and Aetion have collaborated to launch RCT DUPLICATE, an FDA-funded demonstration project in which real-world data is used to replicate the findings of 30 completed Phase III and IV randomized control trials, and to predict the results of seven ongoing Phase IV trials. The project aims to identify when, where, and how RWE sourced from healthcare databases can answer key questions in drug development.

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Real-world evidence (RWE) has had increased impact on the development and commercialization of new treatments. Now, the FDA, prompted by the 21st Century Cures Act, is engaged in a multi-year process to determine exactly how RWE can augment or even substitute randomized clinical trials (RCTs), to get the right treatment to the right patient faster and safely.
 
As part of this commitment, Brigham and Women’s Hospital, Harvard Medical School, and Aetion have collaborated to launch RCT DUPLICATE, an FDA-funded demonstration project in which real-world data is used to replicate the findings of 30 completed Phase III and IV randomized control trials, and to predict the results of seven ongoing Phase IV trials. The project aims to identify when, where, and how RWE sourced from healthcare databases can answer key questions in drug development.
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