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

Activity Details

612 Thu, 8/1/2019, 8:30 AM - 10:20 AM CC-710
Statistics for Clinical Trials and Medical Research — Contributed Papers
Chair(s): Jesus Arroyo, Johns Hopkins University
8:35 AM A Joint Model for Binary Longitudinal and Right-Censored Survival Data in the Context of Antibody Mediated Rejection After Kidney Transplantation

Maarten Coemans, KU Leuven; Aleksandar Senev, KU Leuven; Marie-Paule Emonds, KU Leuven; Maarten Naesens, KU Leuven; Geert Verbeke, Catholic University of Leuven
8:50 AM The Impact of Design Variability on Power of Wald-Type Tests for Treatment Comparisons Under Adaptive Designs

Selvakkadunko Selvaratnam, University of Alberta; Alwell Oyet, Memorial University of Newfoundland; Yanqing Yi, Memorial University of Newfoundland
9:05 AM A Comparative Analysis of Optimal Cut-Off Selection Methods for Multiple Continuous Biomarkers in Immuno-Oncology Research
Hong Wang; Sameera Wijayawardana; Hillary T Graham, Eli Lilly and Company
9:20 AM Statistical Methods for Clinical Study Site Selection

Jianjin Xu, FDA/CDRH; Lan Huang, FDA/CDRH; Zhihao Yao, FDA/CDRH; Zhiheng Xu, FDA/CDRH; Jyoti Zalkikar, FDA/CDRH; Ram Tiwari, CDRH, FDA
9:35 AM Strategy for Similarity Margin Selection in Comparative Clinical Biosimilar Studies
Mengdie Yuan, Food and Drug Administration; Yabo Niu, Texas A&M University; Lei Nie, FDA; Thomas Gwise, FDA; Gregory Levin, FDA; Shein-Chung Chow, FDA
9:50 AM Floor Discussion