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