Legend:
CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
* = applied session ! = JSM meeting theme
Activity Details
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111 * !
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Mon, 7/29/2019,
8:30 AM -
10:20 AM
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CC-102
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Evidence Beyond Traditional Clinical Trials — Invited Papers
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Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Health Policy Statistics Section
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Organizer(s): Martin Ho, FDA
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Chair(s): Chava Zibman, FDA Center for Devices and Radiological Health
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8:35 AM
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Recent Statistical Developments in Considering Real World Evidence for Regulatory Decisioin Making
Martin Ho, FDA; Weili He, AbbVie
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8:55 AM
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Propensity Score-Integrated Approaches for Incorporating Real-World Evidence in Clinical Studies
Chenguang Wang, John Hopkins University
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9:15 AM
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External Evidence: Latest Developments from the Eponymous Medical Device Innovation Consortium Working Group
Theodore Lystig, Medtronic
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9:35 AM
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Use of Past Control Observations Within a Perpetual Platform Trial
Kert Viele, Berry Consultants; Scott Berry, Berry Consultants
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9:55 AM
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Discussant: Telba Irony, FDA CBER
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10:15 AM
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Floor Discussion
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