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

Activity Details

524 Wed, 8/1/2018, 10:30 AM - 12:20 PM CC-West 111
Statistical Issues in Drug Development - 2 — Contributed Papers
Biopharmaceutical Section
Chair(s): Hui Yang, Amgen Inc.
10:35 AM Application of the Win Ratio for Benefit-Risk Analysis

T. Ceesay, Merck ; Shahrul Mt-Isa, Merck; Joseph F. Heyse, Merck Research Laboratories
10:50 AM A Simulation Study of Consistency Evaluation Between Local and Global Results in Multi-Regional Clinical Trials

Chunsheng He, Bristol-Myers Squibb; Jingyi Lin, Duke University; Stephane Munier, Bristol-Myers Squibb; Shein-Chung Chow, Duke University; Lisa Ying
11:05 AM A Comparison of Statistical Models for Recurrent Events with Applications to Hospitalization and Death Events
Jihong Chen, Alnylam Pharmaceuticals; Tim Lin, Alnylam Pharmaceuticals; Matthew T. White, Alnylam Pharmaceuticals; Christine Powell, Alnylam Pharmaceuticals; Andrew Strahs, Alnylam Pharmaceuticals
11:20 AM Addressing the Issue of Subject Confusion Due to the Use of Two Visual Analog Scales in Human Abuse Potential Studies

Ling Chen, CDER, FDA
11:35 AM Rescue Medications from a Statistical Perspective - Case Studies and More
qing li, merck; Man (Mandy) Jin, Merck & Co., Inc.
11:50 AM Propensity Score Methods for Efficacy Comparison in the Lack of Randomization

Qing Li, University of Iowa; Guang Chen, Celgene Corp.
12:05 PM An Evaluation of Statistical Approaches to Post Marketing Surveillance
Yuxin Ding, University at Buffalo; Marianthi Markatou, University at Buffalo; Robert Ball, U.S. Food and Drug Administration,Center for Drug Evaluation and Research