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525 * ! Thu, 8/6/2020, 1:00 PM - 2:50 PM Virtual
Translating Real-World Data into Real-World Evidence for Regulatory Decisions and Medical Practice: Opportunities and Challenges — Invited Papers
Biopharmaceutical Section, Biometrics Section, Health Policy Statistics Section
Organizer(s): Weili He, AbbVie
Chair(s): Hongwei Wang, AbbVie
1:05 PM The Biostatistical Landscape of Regulations, Data Sources, Study Variables, and Estimands for Real-World Evidence
Mark Steven Levenson, FDA/CDER
1:30 PM The Biostatistical Landscape of RWE Study Design and Analysis
Weili He, AbbVie
1:55 PM The Biostatistical Landscape of Causal Inference Frameworks of Clinical Studies using RWD/RWE
Martin Ho, FDA-CBER
2:20 PM Discussant: Frank Rockhold, Duke
2:45 PM Floor Discussion