Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices
A Landscape Assessment
Published in: Value in Health (2021). doi: 10.1016/j.jval.2021.07.003
Posted on RAND.org on November 03, 2021
Real-world evidence (RWE) (as opposed to evidence from clinical trials) is an underutilized resource to support FDA processes and pharmaceutical regulations. Stakeholder interviews suggested the RWE has a role to play, but there are concerns about its rigor.