Enhancing the Application of Real-World Evidence in Regulatory Decision-Making

Event

Conference

Enhancing the Application of Real-World Evidence in Regulatory Decision-Making

March 3, 2016 9:45AM - March 4, 2016 9:45AM

Speakers

Marc L. Berger, MD
Marc M. Boutin, JD
Bill Capra, PhD
William W. Chin, MD
Carrie D’Andrea, RN
Gregory Daniel, PhD, MPH
Nancy Dreyer, PhD, MPH
Rachael Fleurence, PhD
Martin Gibson, MD, PhD
Clifford Goodman, PhD, MS
Jennifer Graff, PharmD
Adrian Hernandez, MD, MHS
Michael Hogarth, MD
Solomon Iyasu, MD, MPH
Jonathan P. Jarow, MD
Lisa LaVange, PhD
K. Kimberly McCleary
Mark McClellan, MD, PhD
Robert Metcalf, PhD
Sally Okun, RN, MMHS
Edmund J. Pezalla, MD, MPH
Richard Platt, MD, MSc
Commander (CDR) Melissa Robb Robert Temple, MD
Sean Tunis, MD, MSc
Marcus D. Wilson, PharmD
Janet Woodcock, MD

Description

The last decade has seen important progress in the development of evidence from routine clinical practice, and there has been a growing interest in harnessing such real-world evidence (RWE) to fill in key information gaps for a variety of health care decision-makers. While payers, providers, and product sponsors have led the way in application of RWE within their respective decision-making frameworks, its use to support or enhance regulatory decisions by the U.S. Food and Drug Administration (FDA) has been relatively limited. Advanced RWE collection efforts and research methods, however, present timely new opportunities for improving clinical trial efficiency and aligning pre- and postmarket evidence generation activities to simultaneously meet regulatory requirements and the broader evidence needs of critical post-regulatory decision-makers. On March 3 and 4, 2016, the Duke-Margolis Center for Health Policy, in cooperation with the FDA, hosted a two-day public conference focused on opportunities for enhancing the use of RWE across a number of potential regulatory. Through presentations and panel discussions, leading experts from across the health care ecosystem discussed the use of RWE to improve clinical trial efficiency and enhance postmarket research efforts; the supporting role of observational studies in a regulatory context; potential criteria and study methods for utilizing randomization within the clinical setting to support regulatory approval decisions; and the policy, data infrastructure, and patient and provider engagement challenges that will need to be overcome to ensure success. This public conference is part of a year-long series of meetings and research activities that the Duke-Margolis Center is undertaking to both explore enhanced and more routine use of RWE within FDA’s regulatory framework and to strengthen the RWE development landscape for all stakeholders.

Funding for this conference was made possible in part by a cooperative agreement from the Food and Drug Administration, Center for Drug Evaluation Research. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.