Understanding FDA’s Real-World Evidence Program: A Presentation of the AMIA Public Policy Committee

June 21, 2019
Free for AMIA members; $50 for non-members
Jacqueline Corrigan-Curay, JD, MD; David Martin, MD, MPH

Increasingly, vast amounts of health-related data are being generated by a diverse array of sources, such as EHRs, medical claims, product and disease registries, laboratory test results and even consumer mobile devices. Because such data reflect the experience of physicians and patients with the actual use of new treatments in practice, and not just in research studies, the collective evaluation of these data sources has the potential to inform clinical decision making by patients and providers, develop new hypotheses for further testing of new products to drive continued innovation and inform us about the performance of medical products. The FDA refers to this as the generation of Real-World Evidence, or RWE.

Please join federal officials for an overview of the FDA’s Framework for Real-World Evidence Program, and learn about what RWE efforts are currently underway at agency’s Center for Drug Evaluation and Research. This is the second in a series of Webinars hosted by AMIA’s Public Policy Committee, where the informatics community is introduced to federal programs and agency officials working at the cutting edge of health informatics policy.

Learning Objectives

After participating in this activity, the learner should be better able to:

  • Describe the FDA’s plans to leverage Real-World Evidence for drug evaluation and research
  • Understand how informatics tools and methods can improve the quality and quantity of RWE
  • Identify opportunities for AMIA and the informatics community to contribute to this growing area of interest

Speaker Information

Jacqueline Corrigan-Curay, JD, MD
Director, Office of Medical Policy, FDA

Jacqueline Corrigan-Curay, J.D., M.D., serves as the Director of the FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Medical Policy (OMP). She leads the development, coordination, and implementation of medical policy programs and strategic initiatives. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.

Dr. Corrigan-Curay earned her law degree from Harvard Law School, her medical degree from University of Maryland School of Medicine, and a bachelor’s degree in history of science from Harvard/Radcliffe College in Cambridge, MA. She completed her training in internal medicine at Georgetown University Medical Center, where she also served as a clinical assistant professor of medicine. She continues to practice internal medicine part-time at the Veterans Affairs Medical Center in Washington, D.C.

David Martin, MD, MPH
Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA

David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research.  He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions, and contributes to medical policy development mandated by the 21st Century Cures Act.  He is also the architect of the open source FDA MyStudies mobile app system. 

As a former Branch Chief, Division Director, and Acting Deputy Office Director, he led analyses of spontaneous reports, formalized risk management planning, and helped develop the Sentinel system. He also served on detail as the FDA Liaison to the European Medicines Agency. Before joining the FDA, he practiced flight and occupational medicine in the U.S. Air Force. He completed his undergraduate degree at the Citadel and his M.D. and M.P.H. at the Johns Hopkins University.  He is board certified in occupational medicine and clinical informatics.