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CC = Baltimore Convention Center,    H = Hilton Baltimore
* = applied session       ! = JSM meeting theme

Activity Details

458 * ! Wed, 8/2/2017, 8:30 AM - 10:20 AM CC-319
New Challenges in Subgroup Analyses and Enrichment Designs — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Frank Bretz, Novartis AG
Chair(s): Rosanne Lane, Janssen Research & Development, LLC
8:35 AM Identification of Subgroups with Heterogeneous Treatment Effect in Dose-Response Studies Bjorn Bornkamp, Novartis Pharma AG ; Marius Thomas, Novartis
8:55 AM Improving Subgroup Identification: Type I Error Control, Power, and the Quality of Subgroups Lei Shen, Eli Lilly and Company
9:15 AM Sample Size Calculation in Confirmatory Subgroup Analyses Dong Xi, Novartis Pharmaceuticals Corporation ; Frank Bretz, Novartis AG ; Ekkehard Glimm, Novartis
9:35 AM Stochastic Optimization of Adaptive Enrichment Designs for Two Subpopulations — Michael Rosenblum, Johns Hopkins University ; Aaron Fisher, Harvard University-Department of Biostatistics ; Joshua A Betz, Johns Hopkins University ; Jon Steingrimsson, Johns Hopkins University
9:55 AM Estimand in Evaluating Predictive or Selection Markers Using Enrichment Design in Clinical Trials Jingjing Ye, FDA
10:15 AM Floor Discussion
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