JSM 2017 Online Program

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

Keyword Search Criteria: medical device returned 11 record(s)

Monday, 07/31/2017

Interim Analysis with Short-Term and Long-Term Endpoint in Adaptive Group Sequential Design
Lin Pan, ICON PLC; Jill Stankowski, ICON PLC

Tuesday, 08/01/2017

Propensity Score Methods for Analysis Time-To-Event Data
Haiying Lin

Propensity Score Methods for Analysis Time-To-Event Data
Haiying Lin
11:00 AM

Incorporation of Stochastic Engineering Models as Prior Information in Bayesian Medical Device Trials
Valentin Parvu, BDX Corporate/Shared services, BD
2:20 PM

Wednesday, 08/02/2017

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
9:25 AM

Companion Diagnostic Device Partial Bridging Study in Precision Medicine - Challenges and Methods
Yaji Xu, FDA/CDRH
10:05 AM

A Bayesian Approach Developed for Single Arm Studies Using Performance Goals with Subgroups
Wei-Chen Chen, FDA/CDRH; Nelson Lu, CDRH/FDA
11:15 AM

Thursday, 08/03/2017

Bayesian Design Applications for Medical Devices Trials Using Power Prior
Songtao Jiang, Boston Scientific Corporation; Peter Lam, Boston Scientific Corporation; Hong Wang, Boston Scientific Corporation
8:50 AM

Statistical Considerations for Studies with a Performance Goal
Xu Yan, U.S. Food and Drug Administration; Heng Li, U. S. FDA; Yun-Ling Xu, U.S. FDA
9:35 AM

Benefit Risk Assessment in Medical Device Clinical Trials
Mourad Atlas, FDA; Chul Ahn, FDA
9:50 AM

Learning Curve Estimation in Medical Devices and Procedures: Hierarchical Modeling
Usha Govindarajulu, SUNY Downstate; Michael Matheny, Vanderbilt University; David Goldfarb, Montefiore Medical Center; Marco Stillo, SUNY Downstate Medical Center; Frederic Resnic, Lahey Clinic
10:05 AM