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

Activity Details

476 Wed, 8/1/2018, 8:30 AM - 10:20 AM CC-West 212
SPEED: Clinical Trial Design, Longitudinal Analysis, and Other Topics in Biopharmaceutical Statistics — Contributed Speed
Biopharmaceutical Section
Chair(s): Mingbin Feng, University of Waterloo
Poster Presentations for this session.
8:35 AM A Stagewise Prognostic Control Predictive Approach (SPCPA) for Subgroup Identification and Its Application in a Phase II Study

Wanying Li, Gilead Sciences; Wangshu Zhang, Gilead Sciences; Lovely Goyal, Gilead Sciences; Yuanyuan Xiao, Gilead Sciences
8:40 AM A Novel Blind Start Study Design to Investigate Vestronidase Alfa for Mucopolysaccharidosis VII, an Ultra-Rare Genetic Disease

Wenjie Song, Ultragenyx Pharmaceutical Inc; Chao-Yin Chen, Ultragenyx Pharmaceutical Inc; Christine Haller, Ultragenyx Pharmaceutical Inc; Emil Kakkis, Ultragenyx Pharmaceutical Inc
8:45 AM Statistical Models for Longitudinal Analysis of Preclinical Efficacy Screens

William Forrest, Genentech, Inc; Bruno Alicke, Genentech; Oleg Mayba, Genentech; Alice Starr, Genentech
8:50 AM Treatment Effect Estimation in Subgroups: a Comparative Study

Weihua Cao, Novartis Pharmaceutical Corp; Bjoern Holzhauer, Novartis Pharma AG; Steffen Ballerstedt, Novartis Pharma AG; Dong Xi, Novartis Pharmaceuticals; Ieuan Jones, Novartis Pharma AG
8:55 AM Sample Size Formulae and Application for the Two-Stage Continual Reassessment Method (CRM)

Cody Chiuzan, Columbia University; Ying Kuen Ken Cheung, Columbia University; Zilan Chai, Columbia University
9:00 AM Single Item Analysis of Patient-Reported Outcome Measures in a Phase III Randomized Controlled Trial
Stacie Hudgens, Clinical Outcome Solutions; Lysbeth Floden, Clinical Outcome Solutions
9:10 AM Incorporating Intermediate Binary Responses into Interim Analysis of a Long-Term Binary Endpoint

Jingjing Chen, Takeda Pharmaceuticals; Tina Liu, Takeda Pharmaceuticals; Andrejus Parfionovas, Takeda Pharmaceuticals; Cong Han, Takeda Pharmaceuticals; Xiaopan Yao, Takeda Pharmaceuticals
9:15 AM MMRM Estimates Consideration for Longitudinal Data in Clinical Trials

Zheng (Jason) Yuan, Vertex Pharmaceuticals; Yaohua Zhang, Vertex Pharmaceuticals; Chenkun Wang, Vertex Pharmaceuticals; Bingming Yi, Vertex Pharmaceuticals
9:20 AM Further Extensions of the Two-Stage Randomized Trial Design for Testing Treatment, Self-Selection and Treatment Preference Effects to Include Count Outcomes

Denise Esserman, Yale University; Yu Shi, Yale University
9:30 AM Sample Size Estimation for Stratified Cluster Randomized Trials with Binary Outcomes

Lee Kennedy-Shaffer, Harvard University; Michael David Hughes, Harvard University
9:35 AM Estimation of Peak Expiratory Flow Under Stochastic Differential Equations

Shan Yang, Merck & Co Inc
9:40 AM A Novel Confidence Interval for a Single Proportion in the Presence of Clustered Binary Outcome Data

Meghan Short, Boston University School of Public Health; Joseph M. Massaro, Boston University
9:45 AM Analysis of Multiple Thresholds in a Responder Analysis of Patient-Reported Outcome Measures

Lysbeth Floden, Clinical Outcome Solutions; Melanie L Bell, University of Arizona; Stacie Hudgens, Clinical Outcome Solutions
9:50 AM A Two-Stage, Phase II Clinical Trial Design with Nested Criteria for Early Stopping and Efficacy: Expected Trial Duration and Tools for Planning
Michelle DeVeaux, Regeneron Pharmaceuticals; Michael John Kane, Yale University; Daniel Zelterman, Yale University
9:55 AM Assessing MCP-Mod Relative to Pairwise Comparisons and Trend Tests in Dose-Ranging Design and Analysis

Anran Wang, Merck & Co Inc; Fang Liu, Merck & Co., Inc; Sammy Yuan, Merck; Man (Mandy) Jin, Merck & Co., Inc.; Meihua Wang, Merck & Co.; Akshita Chawla, Merck & Co Inc; Pranab Kumar Mitra, Merck & Co Inc; Robin Mogg, Merck Research Laboratories
10:00 AM Exposure-Response Analysis with Random Forest

Zifang Guo, Merck; Thomas Jemielita, Merck & Co.; John Kang, Merck
10:05 AM Statistical Considerations of Single Pivotal Vs Two Replicated Confirmatory Studies

Zijiang Yang, Janssen R&D
10:10 AM Reducing the Effects of Misclassification in Sequential Multiple Assignment Randomized Trials (SMART)
Jun He, Virginia Commonwealth University; Donna McClish, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University