Public Workshop: A Framework for Regulatory Use of Real-World Evidence


Public Workshop

Public Workshop: A Framework for Regulatory Use of Real-World Evidence

September 13, 2017 — 9:00AM–4:00PM

1777 F Street Conference Center

The Duke-Margolis Center would like to continue to solicit feedback on the white paper and its proposed framework through an informal comment period that will end Wednesday, October 11, 2017.

We will accept written comments from any and all experts and organizations that would like to provide feedback on the issues contained in the paper, as well as potential ways to further enhance a framework for regulatory use of RWE. Please submit written comments to

Comments will be reviewed and synthesized for a follow-on summary document. Thanks to all of you for your continued involvement in this very important dialogue.

Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and evidence (RWE) in drug development and regulatory decision-making. Topics will include an update on FDA’s implementation of the 21st Century Cures Act’s provisions related to RWE and the development of a framework for tackling challenges related to RWE’s regulatory acceptability. In addition, panelists will discuss opportunities to improve the data development activities, study designs, and analytical methods used to create robust RWE.