Legend:
CC = Vancouver Convention Centre
F = Fairmont Waterfront Vancouver
* = applied session ! = JSM meeting theme
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38
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Sun, 7/29/2018,
2:00 PM -
3:50 PM
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CC-West 119
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Study Design: Historical Controls, Endpoint Timing, and Regulatory Considerations — Contributed Papers
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Section on Medical Devices and Diagnostics
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Chair(s): Dongliang Wang, SUNY Upstate Medical University
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2:05 PM
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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
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2:20 PM
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Strategies for Validating Biomarkers Using Data from a Reference Set
Lu Wang, Fred Hutchinson Cancer Research Center; Ying Huang, Fred Hutchinson Cancer Research Center
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2:35 PM
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An Adaptive Test of Significance in the Presence of Uncertainty in the Timing of the Final Analysis
Jeremy Gorelick, Edwards Lifesciences
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2:50 PM
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Statistical Considerations in Cervical Screening Cytology Device Evaluation
Xiaoqin Xiong, Food and Drug Administration
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3:05 PM
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Leveraging Existing Information in Medical Device Clinical Trials
Rajesh Nair, CDRH/FDA; Xuefeng Li, CDRH/FDA; Laura Thompson, CDRH/FDA
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3:20 PM
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Floor Discussion
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