Legend:
CC = Vancouver Convention Centre
F = Fairmont Waterfront Vancouver
* = applied session ! = JSM meeting theme
150 * !
Mon, 7/30/2018,
10:30 AM -
12:20 PM
CC-East 17
Lead with Statistics in Medical Device Innovations and Beyond — Topic Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section, Statistics in Biopharmaceutical Research Journal
Organizer(s): Yunling Xu, FDA/CDRH
Chair(s): Rajesh Nair, CDRH/FDA
10:35 AM
Use of Real-World Data and Real-World Evidence for Regulatory Decisions: Opportunities and Challenges
Lilly Yue, U.S. Food and Drug Administration ; Nelson Lu, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
10:55 AM
A Propensity Score Stratified Bayesian Power Prior Approach for Incorporating Real-World Evidence in Single Group Medical Device Clinical Studies
Chenguang Wang, John Hopkins University ; Ram Tiwari, Center for Devices and Radiologica Health, FDA; Lilly Yue, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
11:15 AM
Bayesian Approach for Benefit-Risk Assessment with Examples
Ram Tiwari, Center for Devices and Radiologica Health, FDA
11:35 AM
Statistics of Counting Molecules for Precision Medicine
Svilen Tzonev
11:55 AM
Discussant: Gregory Campbell, GCStat Consulting
12:15 PM
Floor Discussion
