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Session 3: RWD and RWE in Support of Clinical Development: Designs, Guidance Gaps, and Practical Strategies
Session Chair(s)
Lina Titievsky, PHD, MPH
Head of Hepatology Epidemiology, GlaxoSmithKline, United States
Hetal Pansuria, PHARMD
Vice President, Regulatory Affairs, Clinical, Nonclinical and Ad-Promo, Pacira Biosciences, United States
Using real-world data in clinical development offers valuable opportunities but also presents regulatory and methodological complexities. This session will explore hybrid and externally controlled trial designs, integration of RWD with randomized trials, and real-world challenges when applying regulatory guidance. Presenters will share case studies and practical approaches to optimize challenges presented by RWD against and regulatory expectations.
Learning Objective : - Apply case-based strategies to resolve methodological challenges and support regulatory-grade evidence generation
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Describe the design and application of hybrid and externally controlled trials using RWD
- Differentiate common sources of misalignment between RWD and regulatory guidance
Speaker(s)
John Seeger, DrPH, PHARMD, FISPE
VIce President, RTI, United States
Requirement for Prudence – Resolving Regulatory RWD/E Guidance Dilemmas
Mingyang Shan, PHD
Senior Director, Eli Lilly and Company, United States
Innovations in Integrating RWD with RCTs: Case Studies with External Controls and Beyond
Xiang Zhang, PHD
Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence, CSL Behring, United States
Speaker
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