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

Activity Details

131 Mon, 7/29/2019, 8:30 AM - 10:20 AM CC-101
Topics in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Guanglei Yu, Eli Lilly and Company
8:35 AM Methods for Evaluating Heterogeneity in Treatment Effects in a Randomized Clinical Trial
Alok Dwivedi, Texas Tech University Health Sciences Center El Paso; Muditha Perera, Texas Tech University Health Sciences Center El Paso; Sada Nand Dwivedi, All India Institute of Medical Sciences; Rakesh Shukla, University of Cincinnati
8:50 AM Estimation of Treatment Effect in a Multi-Regional Clinical Trial with Survival Endpoint
Hsiao-Hui Tsou, National Health Research Institutes; Yu-Chieh Cheng, National Health Research Institutes; Yuh-Jeng Wu, Chung Yuan Christian University; Chin-Fu Hsiao, National Health Research Institutes
9:05 AM Challenges of Filing Externally Conducted Clinical Trials

Kenneth Liu, Merck & Co., Inc; Jonathan Hartzel, Merck & Co., Inc
9:20 AM An Integrative Shrinkage Estimator for Random-Effects Meta-Analysis of Rare Binary Events

Lie Li, Merck & Co.; Xinlei Wang, Southern Methodist University; Ou Bai, NA
9:35 AM Exploring Heterogeneity of Treatment Response: Assumptions, Logic, Algorithm, Computations

Lev Sverdlov, Redmond Analytics, LLC
9:50 AM Dynamic Data Monitoring for On-Going Clinical Trials
Tai Xie, Brightech International; Ping Gao, Brightech International; Peng Zhang, Brightech International; Yue Tu, Brightech International; Joe Shih, Rutgers University
10:05 AM Blinded Safety Monitoring in Clinical Trials and IND Safety Reporting: Challenges and Lessons Learned

Barbara Hendrickson, AbbVie