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CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details

111 * ! Mon, 7/29/2019, 8:30 AM - 10:20 AM CC-102
Evidence Beyond Traditional Clinical Trials — Invited Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Health Policy Statistics Section
Organizer(s): Martin Ho, FDA
Chair(s): Chava Zibman, FDA Center for Devices and Radiological Health
8:35 AM Recent Statistical Developments in Considering Real World Evidence for Regulatory Decisioin Making
Martin Ho, FDA; Weili He, AbbVie
8:55 AM Propensity Score-Integrated Approaches for Incorporating Real-World Evidence in Clinical Studies

Chenguang Wang, John Hopkins University
9:15 AM External Evidence: Latest Developments from the Eponymous Medical Device Innovation Consortium Working Group

Theodore Lystig, Medtronic
9:35 AM Use of Past Control Observations Within a Perpetual Platform Trial

Kert Viele, Berry Consultants; Scott Berry, Berry Consultants
9:55 AM Discussant: Telba Irony, FDA CBER
10:15 AM Floor Discussion