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CC = Baltimore Convention Center,    H = Hilton Baltimore
* = applied session       ! = JSM meeting theme

Activity Details

438 * ! Wed, 8/2/2017, 8:30 AM - 10:20 AM CC-308
Real-World Evidence in Clinical Trial: New Era of Informed Decision Making Session — Invited Papers
Biopharmaceutical Section , Health Policy Statistics Section , Society for Medical Decision Making , Section on Medical Devices and Diagnostics
Organizer(s): Satrajit Roychoudhury, Pfizer Inc
Chair(s): Margaret Gamalo-Siebers, Eli Lilly
8:35 AM Real World Evidence to Support Accelerated Approval Processes — Sebastian Schneeweiss, Harvard Medical School ; Jessica Franklin, Harvard Medical School
9:00 AM Assessing the impact of informative censoring on overall survival in a RWD source. Bill Capra, Genentech Inc. ; Gillis Carrigan, Genentech Inc. ; Michael Taylor, Genentech Inc. ; Brandon Arnieri, Genentech Inc. ; Melissa Curtis, Flatiron Health ; Sandy Griffith, Flatiron Health ; Aracelis Torres, Flatiron Health ; Philip Hofmeister, Flatiron Health ; Anala Gossai, Flatiron Health ; Samuel Whipple, Genentech Inc ; Peter Lambert, Genentech Inc
9:25 AM Statistical Design Considerations for Utilizing Real World Data in Premarket Evaluation of Medical Devices Yunling Xu, CDRH/FDA ; Nelson Lu, CDRH/FDA ; Lilly Yue, Division of Biostatistics, CDRH/ U.S. FDA ; Ram Tiwari, FDA/CDRH
9:50 AM Discussant: Douglas E Faries, Eli Lilly
10:15 AM Floor Discussion
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