Aetion, Brigham and Women's partnerships will inform FDA RWE standards

FDA is expanding its real-world evidence partnership with Brigham and Women's Hospital and Aetion to use real-world evidence to predict clinical outcomes from trials. The results from this expansion should help the agency identify when and how RWE could provide robust estimates of safety and efficacy to support sNDAs.

On Wednesday, the partners announced that they would use Aetion's platform and healthcare claims data to predict safety and efficacy outcomes of seven ongoing clinical trials...