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 on November 03, 2021

by Justin W. Timbie, Alice Y. Kim, Thomas W. Concannon

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.

Research conducted by

This report is part of the RAND Corporation External publication series. Many RAND studies are published in peer-reviewed scholarly journals, as chapters in commercial books, or as documents published by other organizations.

The RAND Corporation is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.