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CC = Vancouver Convention Centre   F = Fairmont Waterfront Vancouver
* = applied session       ! = JSM meeting theme

Activity Details

38 Sun, 7/29/2018, 2:00 PM - 3:50 PM CC-West 119
Study Design: Historical Controls, Endpoint Timing, and Regulatory Considerations — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Dongliang Wang, SUNY Upstate Medical University
2:05 PM Application of Propensity Score Quintile Matching for Baseline Parameters in a Medical Device Trial Design

Hong Wang, Boston Scientific Corporation; Songtao Jiang, Boston Scientific; Peter Lam, Boston Scientific
2:20 PM Strategies for Validating Biomarkers Using Data from a Reference Set

Lu Wang, Fred Hutchinson Cancer Research Center; Ying Huang, Fred Hutchinson Cancer Research Center
2:35 PM An Adaptive Test of Significance in the Presence of Uncertainty in the Timing of the Final Analysis

Jeremy Gorelick, Edwards Lifesciences
2:50 PM Statistical Considerations in Cervical Screening Cytology Device Evaluation

Xiaoqin Xiong, Food and Drug Administration
3:05 PM Leveraging Existing Information in Medical Device Clinical Trials
Rajesh Nair, CDRH/FDA; Xuefeng Li, CDRH/FDA; Laura Thompson, CDRH/FDA
3:20 PM Floor Discussion