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Leveraging Real-World Evidence and External Controls in Clinical Trials of Rare Outcomes/Small Trials: Statistical Innovation
Session Chair(s)
Huan Wang, PHD
Mathematical Statistician, CDER
FDA, United States
Learn how the RWE can be utilized in trials of rare outcomes or small trials. Speakers from industry, academia, and regulators share insights on external controls, causal inference, and evidence synthesis to inform regulatory submissions.
Learning Objective : Identify when to use external controls for rare outcomes or small trials using RWE sources; Design RWE-based studies and apply causal inference methods to address confounding, missing data, and intercurrent events; Evaluate robustness of study results with diagnostics and sensitivity analyses.
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