Legend:
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
|
|
