JSM 2016 Online Program

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Sessions Were Renumbered as of May 19.

Legend:
CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

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

Sunday, 07/31/2016

A Constancy-Enforced Noninferiority Design of Medical Device Trials with a Binary Endpoint
Ying Yang, FDA/CDRH; Yunling Xu, FDA/CDRH; Nelson LU, FDA/CDRH; Yu Zhao, FDA
2:20 PM

Incorporation of Historical Information in Bayesian Analysis of Crossover Medical Device Clinical Trials
Youssef Toubouti, Johnson & Johnson Vision Care; Xiwei Chen, Johnson & Johnson Vision Care
2:35 PM

On Weighted Performance Goals in Medical Device Single-Arm Clinical Studies
Nelson LU, FDA/CDRH; Yunling Xu, FDA/CDRH
2:50 PM

Developing and Validating Visual Assessment Tools for Use in Medical Device Trials
Alvin Van Orden, FDA
3:05 PM

Statistical Study Design Considerations for Medical Device Clinical Studies from an FDA Reviewer's Perspective
Xu Yan, FDA; Heng Li, FDA; Vandana Mukhi, FDA
3:35 PM

Monday, 08/01/2016

Best Practices for Communicating with FDA CDRH Statistical Reviewers
Christopher Mullin, NAMSA

Design and Analysis of Multiregional Clinical Trials in Evaluation of Medical Devices: Some Points to Consider from a Regional Regulatory Perspective
Yunling Xu, FDA/CDRH; Nelson LU, FDA/CDRH
8:55 AM

Wednesday, 08/03/2016

Patient Preference in Benefit-Risk Analysis in Medical Device Trials
Xuefeng Li, FDA
2:25 PM

Thursday, 08/04/2016

Statistical Considerations in Evaluating Radiological Imaging Devices in FDA/CDRH
Qin Li, FDA/CDRH
8:55 AM

Different Success Criteria in the Performance Evaluation of Diagnostic Devices
Norberto Pantoja-Galicia, FDA/CDRH; Gene Pennello, FDA/CDRH/OSB/DBS
9:15 AM

Creating a Biomarker Signature for a Companion Diagnostic Using Bootstrapping and Aggregating Thresholds from Tree-Based Models
Raj Chandran
9:35 AM

JSM 2016 Online Program

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ASA Meetings Department

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