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Tuesday, June 21 • 11:15am - 12:15pm
#231: Leveraging Real-World Evidence for Regulatory Purposes

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-562-L04-P ; CME 1.00; RN 1.00

This session discusses challenges and considerations in the design and implementation of real-world evidence studies including registry-based pragmatic trials and external control studies, based on real applications.

Learning Objectives

Demonstrate various designs of a real-world evidence study; Identify the challenges to plan and conduct a real-world evidence study; Discuss considerations for those challenges.

Chair

Yueqin Zhao, PhD

Speaker

Regulatory Considerations on Leveraging Real World Evidence
Di Zhang, PhD

DAPA-MI: World’s First Indication-Seeking Registry-Based Randomized Controlled Trial
Jingyu (Julia) Luan, PhD

The Use of a Real-World Data as a Hybrid Control in PAH
Brian Hennessy, MSc



Speakers
BH

Brian Hennessy

Senior Director Statistician, Janssen, Switzerland
Brian Hennessy is a Senior Director of Statistics and Decisions Sciences in Janssen. He has over 20 years experience in the pharmaceutical industry. He has significant experience in regulatory interactions, innovative clinical trial design and practical use of real-world data in clinical... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D, AstraZeneca, United States
Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing... Read More →
DZ

Di Zhang

Statistical Reviewer, OB, OTS, CDER, FDA, United States
Di Zhang, Ph.D., is a Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. She holds a Ph.D. degree in Biostatistics from the University of Pittsburgh. Di specializes in causal inference using real-world data and leveraging real-world... Read More →
YZ

Yueqin Zhao

Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States
Yueqin Zhao is a lead mathematical statistician in Office of Biostatistics, Center for Drug Evaluation and Research, FDA. Her research interests include benefit-risk assessment, signal detection, and statistical methods in observational studies.


Tuesday June 21, 2022 11:15am - 12:15pm CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  11: Statistics, Session