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128 * Mon, 8/4/2014, 8:30 AM - 10:20 AM CC-258B
Statistical Methods for Early Stopping and Go/No-Go Decision — Contributed Papers
Biopharmaceutical Section
Chair(s): Lihan Yan, FDA   
8:35 AM Properties of Covariate-Adjusted Response-Adaptive Designs with Early Stopping Yaping Wang, University of Texas Health Science Center at Houston ; Jack Lee, MD Anderson Cancer Center ; Hongjian Zhu, University of Texas School of Public Health
8:50 AM Group-Sequential Strategies When Considering Multiple Binary Outcomes as Co-Primary Endpoints Toshimitsu Hamasaki, Osaka University Graduate School of Medicine ; Koko Asakura, Osaka University ; Scott R. Evans, Harvard School of Public Health
9:05 AM Comparison Between Adaptive Designs for Bio-Equivalence Study Shuai Yuan, Merck ; Fang Liu, Merck ; Jialin Xu, Merck
9:20 AM Predictive Approach in Group Sequential Design for Time-to-Event Endpoint Soumi Lahiri, Novartis ; Satrajit Roy Choudhury, Novartis
9:35 AM Futility Monitoring with Conditional Power: A Rationale for the Choice of Theta Assumption Based on Type II Error Probability Thomas Dobbins, Merck
9:50 AM Continuous Covariate Imbalance and Conditional Power for Clinical Trial Interim Analyzes Jody Ciolino, Northwestern University ; Renee' Martin, Medical University of South Carolina ; Wenle Zhao, Medical University of South Carolina ; Edward Jauch, Medical University of South Carolina ; Michael Hill, University of Calgary ; Yuko Palesch, Medical University of South Carolina
10:05 AM Single-Arm Two-Stage Phase 2 Clinical Trials with Go/No-Go/Grey-Zone Outcomes Bob Zhong, Johnson & Johnson



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