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Activity Details

337 * ! Tue, 8/1/2017, 10:30 AM - 12:20 PM CC-315
Interim Monitoring and Analyses: Two-Stage, Multi-Stage, and Group Sequential Designs — Contributed Papers
Biopharmaceutical Section
Chair(s): Mike Henderson, SAS
10:35 AM Decision of Performing Interim Analysis for Comparative Clinical Trials Kyongsun Pak, Kitasato University ; Susanna Jacobus, Dana Farber Cancer Institute ; Hajime Uno, Dana Farber Cancer Institute
10:50 AM The Three Keys to Having Effective Interim Review Data Monitoring Committee Meetings for Clinical Trials Navneet Hakhu, Axio Research
11:05 AM Determination of Interim Go/No-Go Criteria with Simulations of Longitudinal Continuous Data in a Phase 2 Clinical Trial of a Neurodegenerative Disorder Weining Z Robieson, AbbVie Inc. ; Greg Cicconetti, Abbvie ; Deli Wang, AbbVie, Inc.
11:20 AM Robust Inference for Group Sequential Trials Jitendra Ganju ; Yunzhi Lin, AbbVie ; Kefei Zhou, Theravance
11:35 AM Strategies in Designing Interim Analyzes Under Discrete Random-Effects Model in a Multiregional Trial Hsiao-Hui Tsou, National Health Research Institutes ; Chi-Tian Chen, National Health Research Institutes ; K. K. Gordon Lan, Janssen Pharmaceutical Companies of Johnson & Johnson ; Chin-Fu Hsiao, National Health Research Institutes
11:50 AM Multi-Arm Multi-Stage Group Sequential Design in Clinical Trial Pranab Ghosh, Cytel Inc, Boston University ; Cyrus Mehta, Cytel Inc
12:05 PM Extension of the Two-Stage Randomized Trial Design for Testing Treatment, Self-Selection, and Treatment Preference Effects to Binary Outcomes Briana Cameron, Yale University ; Denise Esserman, Yale School of Public Health ; Peter Peduzzi, Yale School of Public Health
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