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78 * Mon, 8/9/2021, 10:00 AM - 11:50 AM Virtual
Key Steps in Deriving Real-World Evidence from Analysis of Real-World Data — Topic-Contributed Papers
Biopharmaceutical Section, Biometrics Section, Section on Statistical Learning and Data Science
Organizer(s): Yixin Fang, AbbVie
Chair(s): Weili He, AbbVie
10:05 AM Estimands: From Concepts to Applications in Real-World Setting (RWS)
Jie Chen, On behalf of ASA Biop RWE SWG Estimand Team
10:25 AM Principles and Approaches for the Use and Evaluation of Fit-for-Purpose, Real-World Data Sources
Mark Levenson, FDA; Weili He, AbbVie
10:45 AM Examples of Applying Causal-Inference Roadmap to RWE Clinical Studies
Martin Ho, Google; Yixin Fang, AbbVie
11:05 AM From Sensitivity Analysis to Evidence-Value: Ways to Interpret Real-World Evidence
Yixin Fang, AbbVie ; Weili He, AbbVie
11:25 AM Discussant: Hana Lee, FDA
11:45 AM Floor Discussion