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CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details

342 * Tue, 7/30/2019, 10:30 AM - 12:20 PM CC-109
Topics in Adaptive-Seamless and Group Sequential Designs — Contributed Papers
Biopharmaceutical Section
Chair(s): Qi Jiang, Seattle Genetics
10:35 AM Adaptive Sequential Design for Seamless Phase 2/3 Combination

Ping Gao, Brightech International; Tai Xie, Brightech International; Peng Zhang, Brightech International; Yue Tu, Brightech International; Lingyun Liu, Cytel; Cyrus Mehta, Cytel
10:50 AM Selecting Critical Boundaries in Group-Sequential Trials with Multiple Endpoints
Toshimitsu Hamasaki, National Cerebral and Cardiovascular Center; Hsien-Ming James Hung, PhD, Food and Drug Administration; Chin-Fu Hsiao, National Health Research Institutes; Scott R Evans, George Washington University
11:05 AM Covariate Adaptive Randomization in Seamless Phase II/III Clinical Trials

Hongjian Zhu, University of Texas Health Science Center at Houston; Wei Ma, Renmin University; Mengxi Wang, University of Texas Health Science Center at Houston
11:20 AM Evaluation of Type 1 Error in a 2-In-1 Adaptive Phase 2/3 Design with Dual-Primary Endpoints in Oncology Studies

Li Fan, Merck; Jing Zhao, Merck Research Labs
11:35 AM Implementation of an Adaptive Early Phase Trial Design for Drug Combinations
Bethany Horton, University of Virginia; Nolan Wages, University of Virginia
11:50 AM Developing Innovative Group Sequential Design Trials That Account for the Correlation Between Test Statistics

JonDavid Sparks, Eli Lilly & Company; Bill Prucka, Eli Lilly & Company; Brian Millen, Eli Lilly & Company
12:05 PM Unblinded Sample Size Re-Estimation in Clinical Trials with Count Outcomes
Yeting Du, Cytel Inc; Lingyun Liu, Cytel