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Monday, 08/02/2010
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Establishing Sample Size in Clinical Trials Having Multiple Hypotheses
Alan Barry Davis, Pharmanet Development Group, Inc.; Mary M. Poole, Pharmanet Development Group, Inc.; Young Kim, Pharmanet Development Group, Inc.
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Definition of a Responder in Clinical Trials for Alcohol Dependence
Yun-Fei Chen, Eli Lilly and Company ; Xiwen Ma, University of Wisconsin-Madison
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Comparison of Power for ANCOVA Models Based on Central Tendency versus Nonparametric Analysis of Cumulative Responders for Clinical Trials with Continuous Response Endpoints
Kevin L. Lawson, PPD, Inc.
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Two-Stage Designs with Additional Futility Tests for Phase II Clinical Trials with Heterogeneous Patient Populations
Myron N. Chang, University of Florida; Sin-Ho Jung, Duke University
10:05 AM
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Generalizing Evidence from Randomized Clinical Trials to Target Populations: The ACTG-320 Trial
Elizabeth Stuart, Johns Hopkins Bloomberg School of Public Health; Stephen R. Cole, The University of North Carolina at Chapel Hill
2:05 PM
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Detecting a Cutoff Point for Predictive Biomarkers in Clinical Trials Using Contrast Tests
Jianliang Zhang, MedImmune
2:20 PM
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Evaluating Medical Imaging Reader Performance in Clinical Trials
David L. Raunig, Pfizer Inc.; Patricia English, Pfizer Inc.
2:30 PM
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Choice of Multiple Comparison Procedure in Two Pivotal Clinical Trials for Approval of a New Pharmaceutical Product: Power and Aesthetics
Brian L. Wiens, Alcon Laboratories, Inc.; Alex Dmitrienko, Eli Lilly and Company
3:05 PM
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Tuesday, 08/03/2010
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Using Statistical Concepts to Determine Risk Level of Randomized Clinical Trials That Compare Two Noninvestigational Therapies
Martin L. Lesser, Feinstein Institute for Medical Research; Nina E. Kohn, Feinstein Institute for Medical Research
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Analysis of Missing Mechanism in IVUS Imaging Clinical Trials with Missing Covariates
Tianyue Zhou, sanofi-aventis; Ming-Xiu Hu, Millennium Pharmaceuticals, Inc.
10:35 AM
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Use Multiple Imputation to Handle Missing Data in Longitudinal Clinical Trials with Multiple Correlated Endpoints
Yahong Peng, Pfizer Inc.; Lian Liu, Roche Product Development in Asia Pacific; Ruifeng Xu, Merck Research Laboratories
11:20 AM
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Evaluating the Effect of Early vs. Late ARV Regimen Change After Failing on an Initial Regimen: Results from the AIDS Clinical Trials Group Study A5095
Li Li, Emory University; Brent Johnson, Emory University; Joseph Eron, The University of North Carolina at Chapel Hill; Heather Ribaudo, Harvard University; Roy Gulick, Cornell University
11:20 AM
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A Gatekeeping Multiple Comparison Procedure Based on the Hommel Test for Clinical Trials with Hierarchically Ordered Objectives
Thomas Brechenmacher, Dainippon Sumitomo Pharma Co., Ltd.; Jane Xu, Dainippon Sumitomo Pharma America, Inc.; Alex Dmitrienko, Eli Lilly and Company; Ajit C. Tamhane, Northwestern University
3:05 PM
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Interval Estimation in Two-Stage, Drop-the-Losers Clinical Trials with Flexible Treatment Selection
Dan Neal, University of Florida; George Casella, University of Florida; Mark Yang, University of Florida; Samuel S. Wu, University of Florida
3:05 PM
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Inference for Treatment Efficacy on Survival Probability in Randomized Clinical Trials with Noncompliance
Ying Zhou, University of California, Los Angeles
3:05 PM
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Wednesday, 08/04/2010
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The Benefit of Stratified Clinical Trials Revisited
Jitendra Ganju, Amgen Inc.; Kefei Zhou, Amgen Inc.
8:50 AM
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Assessing Treatment Effect in Clinical Trials with Dichotomous Endpoints
Gang Jia, Merck & Co., Inc.
9:20 AM
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Properties of Re-Randomization Tests in Clinical Trials with Adaptive Randomization
Stephen Lake, Genzyme Corporation; Cyrus R. Mehta, Cytel Inc.; L. J. Wei, Harvard University
2:35 PM
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Drug Regimen Selection in Early-Stage Two-Arm Oncology Clinical Trials
Guohui Liu, Millennium Pharmaceuticals, Inc.; Xuedong Chi, Millennium Pharmaceuticals, Inc.
3:05 PM
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