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CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details

77 Sun, 7/28/2019, 4:00 PM - 5:50 PM CC-111
Complex Designs and Composite Endpoints of Medical Device Clinical Studies and Benefit-Risk Analysis of Diagnostic Tests — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Jianjin Xu, FDA/CDRH
4:05 PM Survey of Composite Endpoints in Therapeutic PMA Submissions

Rajesh Nair, CDRH/FDA; Natasha Sahr, St. Jude's Children's Hospital; Ja-An Lin, FDA/CDRH
4:20 PM A Simulation of Various Missing Data Imputation Methods in the Application of Composite Endpoint

Ja-An Lin, FDA/CDRH; Rajesh Nair, CDRH/FDA; Natasha Sahr, St. Jude's Children's Hospital
4:35 PM A Practical Perspective: Application of the Generalized Approach for Adaptive Design
Jin Wang, Abbott Vascular; juanjuan li, abbott; Yu Shu, Abbott; xiaolu su, abbott
4:50 PM Survival Analysis of Hierarchical Learning Curves in Assessment of Cardiac Device and Procedural Safety

Usha Govindarajulu, SUNY Downstate Medical Center; Sandeep Bedi, SUNY Downstate; Aaron Kluger, Baylor University; Frederic Resnic, Lahey Hospital and Medical Center
5:05 PM Proposing How to Establish Analytical Measuring Range When the Comparator’s Range Is Shorter in Method Comparison Studies
Kyungsook Kim, FDA; Meijuan Li, FDA
5:20 PM Benefit-Risk (BR) Evaluation for Diagnostic Tests

Jeng Mah, Beckman Coulter
5:35 PM Floor Discussion