JSM 2015 Preliminary Program

Online Program Home
My Program

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

For program information, contact the JSM Registration Department or phone (888) 231-3473.

For Professional Development information, contact the Education Department.

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

2015 JSM Online Program Home