JSM 2015 Preliminary Program

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Legend: Washington State Convention Center = CC, Sheraton Seattle = S, Grand Hyatt = GH and The Conference Center = TCC
* = applied session       ! = JSM meeting theme

Activity Details
188 Mon, 8/10/2015, 10:30 AM - 12:20 PM CC-307
Design and Analysis of Pivotal Studies for Medical Devices — Contributed Papers
Section on Medical Devices and Diagnostics , Biometrics Section
Chair(s): Mary McGarigle, Thoratec Corporation
10:35 AM Considerations in Using Registry Data to Support Pre-Market Applications of Medical Devices — Nelson Lu, FDA/CDRH ; Lilly Yue, FDA/CDRH ; Yunling Xu, FDA/CDRH
10:50 AM Adaptive Sample Size Re-Estimation with Fisher's Exact Test and a Promising Zone — Tyson Rogers, NAMSA ; Scott McKane, Respicardia, Inc.
11:05 AM Considerations in Sample Size, Type I Error, and Power for 2-Group Noninferiority Study Using Farrington-Manning Method — Songtao Jiang, Boston Scientific ; Edmund McMullen, Boston Scientific ; Hong Wang, Boston Scientific ; Terry Liao, Boston Scientific
11:20 AM Analysis of Composite Endpoint with Missing Data in Components — Ying Yang, FDA ; Terry Liao, Boston Scientific ; Ying Yan, Helsinn Therapeutics (U.S.), Inc.
11:35 AM Coarsened Propensity Scores and Hybrid Estimators for Missing Data and Causal Inference — Jack Zhou, FDA/CDRH ; Zhiwei Zhang, FDA/CDRH ; Zhaohai Li, The George Washington University ; Jun Zhang, Shanghai Jiaotong University School of Medicine
11:50 AM Issues with Training, Testing, and Validation Data Sets in the Development of Diagnostics Devices — R. Lakshmi Vishnuvajjala, FDA
12:05 PM Optimizing Accuracy of a Sequence of Tests: How Do We Determine the Order of the Tests? — Christine Schubert Kabban, Air Force Institute of Technology ; Donna K. McClish, Virginia Commonwealth University




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