Legend: CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
Activity Details
612
Thu, 8/1/2019,
8:30 AM -
10:20 AM
CC-710
Statistics for Clinical Trials and Medical Research — Contributed Papers
ENAR
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
