Back To Schedule
Wednesday, June 27 • 4:00pm - 5:15pm
#397: Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision Making

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-686-L04-P; CME 1.25; IACET 1.25; RN 1.25

Regulators expect drug makers to conduct novel studies to provide treatment effectiveness results that are valid in everyday clinical practice. This session will present opportunities and challenges in pragmatic trials to generate real-world insights.

Learning Objectives

Discuss the usefulness of pragmatic clinical trials to support regulatory decision making and shortening drug approval time; Describe how pragmatic trials offer avenue to obtain real-world data to support comparative effectiveness research; Describe design and statistical considerations for pragmatic trials to produce acceptable, valid, precise, and generalizable results.


Yeh-Fong Chen, PhD


Design and Statistical Considerations in Real-World Evidence
Jennifer Hsiang-Ling Lin, PhD

Pragmatic Clinical Trials: The Future is Now
David Thompson, PhD

avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER, FDA
Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug... Read More →

Jennifer Hsiang-Ling Lin

Associate Director, RWE Design and Analytics, Janssen Pharmaceuticals
Jennifer currently works at Janssen as a research scientist specializing in patient outcomes and treatment effectiveness. Before joining Janssen, she was at Takeda, leading an observational research analytics team in support of company products via use of RWD. She was also the principal... Read More →
avatar for David Thompson

David Thompson

Senior Vice President, Real World Evidence, Syneos Health
David Thompson, Ph.D. is Senior Vice President, Real World Research for Syneos Health. Dave is a health economist by training with 25+ years of experience conducting real-world research and consulting for clients in the biopharmaceutical sector. He is Editor-in-Chief of ISPOR’s... Read More →

Wednesday June 27, 2018 4:00pm - 5:15pm EDT
Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session