|
Monday, 08/02/2010
|
Calculating an Exact p-Value for a Noninferiority Test on Matched Pair Data
Jennifer E. Hamer-Maansson, AstraZeneca
|
Sample Size Requirement in Clustered Matched-Pair Design for Noninferiority Test
Jun-mo Nam, National Cancer Institute
11:20 AM
|
Designing Noninferiority Study: A New Perspective
George Y.H. Chi, Johnson & Johnson; Gang Li, Johnson & Johnson; Qing Liu, Johnson & Johnson
11:35 AM
|
An Adaptive Noninferiority Study
Pilar Lim, Johnson & Johnson; Qing Liu, Johnson & Johnson; Rosanne Lane, Johnson & Johnson; Barry Schwab, Johnson & Johnson; Allan Sampson, University of Pittsburgh
2:45 PM
|
Direct Inference Requiring Only a Touch of Bayes
Ralph G. O'Brien, Case Western Reserve University
2:50 PM
|
|
Tuesday, 08/03/2010
|
A Graphical Approach to Multiple Test Procedures for Adaptive Phase II/III Clinical Trials
Martin Posch, Medical University of Vienna
9:25 AM
|
Optimal Phase II Decision Rules in a Seamless PhaseII/III Clinical Trial
Bo Jin, Merck Research Laboratories
2:05 PM
|
Evaluation of the Strength of Bridging Evidence
Hsiao-Hui Tsou, National Health Research Institutes, Taiwan; Jung-Tzu Liu, National Health Research Institutes, Taiwan; Chin-Fu Hsiao, National Health Research Institutes, Taiwan; Yi Tsong, CDER/FDA
2:25 PM
|
|
Wednesday, 08/04/2010
|
Demonstrating Superiority of Test Drug to Putative Placebo in the Two-Arm Noninferiority Trial
Abdul J. Sankoh, Vertex Pharmaceuticals
|
A Comparison of the Results of Intent-to-Treat, per-Protocol, and g-Estimation in the Presence of Nonrandom Treatment Changes in a Time-to-Event Noninferiority Trial
Yutaka Matsuyama, The University of Tokyo
10:55 AM
|
Sensitivity Analyses Adjusting for Early Discontinuation of Study Medication in the RE-LY Trial: An Open-Label, Randomized, Active-Controlled, Time-to-Event Noninferiority Trial
Xiuyu Cong, Boehringer Ingelheim Pharmaceuticals, Inc.; Qiqi Deng, Boehringer Ingelheim Pharmaceuticals, Inc.; Susan Q. Wang, Boehringer Ingelheim Pharmaceuticals, Inc.
11:15 AM
|
|
Thursday, 08/05/2010
|
Sample Size Determination for Two-Stage Equivalence Test
Mi-Chia Ma, National Cheng Kung University; Shang-Bo Ye, National Cheng Kung University
8:35 AM
|
Statistical Analysis Considerations in Device Trial Planning
Helen Marie Chmiel, Zimmer, Inc.; Kim Perry, Innovative Analytics
8:50 AM
|
Exact Sample Size Calculations for Noninferiority Trials with Binomial Endpoints
Cyrus R. Mehta, Cytel Inc.; Lingyun Liu, Cytel Inc.; Pralay Senchaudhuri, Cytel Inc.
9:20 AM
|
Impact of Missing Data on Type 1 Error Rates in Noninferiority Trials
Bongin Yoo, Bristol-Myers Squibb
11:35 AM
|
|