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Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision Making
Session Chair(s)
Yeh-Fong Chen, PhD
Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
United States
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 Objective : 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.
Speaker(s)
Design and Statistical Considerations in Real-World Evidence
Jennifer Hsiang-Ling Lin, PhD
Janssen Pharmaceuticals, United States
Associate Director, RWE Design and Analytics
Pragmatic Clinical Trials: The Future is Now
David Thompson, PhD
Rubidoux Research LLC, United States
Founder and Principal Consultant
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