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  4. FDA-AACR Workshop: Real-world Evidence - 07/19/2019 - 07/19/2019
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Meeting | In Person

Event Title
FDA-AACR Workshop: Real-world Evidence
July 19, 2019

July 19, 2019
Event Location
DoubleTree by Hilton Hotel Bethesda-Washington DC
(301) 652-2000

8120 Wisconsin Ave
Bethesda, MD 20814-3625
United States

Co-sponsored by the
U.S. Food and Drug Administration (FDA) and
the American Association for Cancer Research (AACR)



U.S. Food and Drug Administration

Sean Khozin, MD, MPH
Associate Director, Oncology Center of Excellence, 
Director, Information Exchange and Data Transformation (INFORMED)

Pallavi Mishra-Kalyani, PhD 
Team Leader, Division of Biometrics V, 
Office of Biostatistics, Center for Drug Evaluation and Research

American Association for Cancer Research

Deborah Schrag, MD, MPH 
Chief, Division of Population Sciences, Dana-Farber Cancer Institute


Stemming from policy mandates established by the 21st Century Cures Act and PDUFA VI, there has been considerable progress in using real-world evidence (RWE) to support research efforts, ranging from retrospective cohort studies to prospective randomized trials in real-world settings. To fulfill the mandate to further advance RWE, the U.S. Food and Drug Administration recently released the Framework for FDA’s Real-World Evidence Program. This workshop will discuss the agency’s work thus far on the implementation of that framework while exploring the current state of RWE in oncology. Speakers will examine pre- and post- market use cases in which RWE was utilized to improve and accelerate treatment development and patient care and explore the potential of large genomic databases as real-world data sources. This event will also look to the future of RWE and consider how ongoing efforts will impact the oncology drug development landscape.

Workshop Objectives

•    Discuss current challenges and opportunities for real-world evidence.
•    Provide a forum for academic, industry and regulatory experts to discuss real-world evidence.
•    Brainstorm ways that academia, industry, NCI and FDA can work together to advance the science in this area.

Webcast Information

AACR will provide a free-of-charge, live webcast of this workshop. Further information regarding the webcast, including the web link for the webcast, will be made available closer to the workshop date.

FDA plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.



Sarah Martin, MS , PhD


Valerie Vashio

Event Materials

Title File Type/Size
FDA-AACR Workshop: Real-world Evidence Agenda July 2019 pdf (861.53 KB)
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