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Sunday, 08/01/2010
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Follow-Up of Subjects in Event Rates for Periodic Safety Monitoring Reports in Open Enrollment Clinical Trials
Maria Carola Alfaro, Boston Scientific Corporation
4:05 PM
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A Novel Semiparametric Ratio Estimator: A Key to Predicting Long-Term Weight Loss in Obesity
Deborah Weissman-Miller, Dwbus & Assoc. Inc.
4:05 PM
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Bayesian Adaptive Designs for Dose Escalation Studies
Anna Elizabeth McGlothlin, Eli Lilly and Company
4:05 PM
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Inference on Treatment Effect Under a Density Ratio Model and Random Censoring
Shan Jiang, Queen's University; Dongsheng Tu, Queen's University
4:20 PM
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An Evaluation of a Simon 2-Stage Phase II Clinical Trial Design Incorporating Continuous Toxicity Monitoring
Herman Ray, University of Louisville; Shesh Rai, University of Louisville
4:20 PM
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Issues of Missing Data in Orthopedic Implant Clinical Trials: A Regulatory Reviewer's Perspective
Jianxiong Chu, FDA
4:25 PM
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Exact Two-Stage Designs for Phase II Clinical Trials with Rank-Based Endpoints
Gregory E. Wilding, State University of New York at Buffalo; Guogen Shan, State University of New York at Buffalo; Alan Hutson, State University of New York at Buffalo
4:35 PM
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Interval-Censored Time-to-Event Data in Clinical Trials: Analyzing and Designing
Xing Sun, Merck & Co., Inc.; Cong Chen, Merck & Co., Inc.
4:50 PM
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A Bayesian Dose-Finding Design Adapting to Efficacy and Tolerability Response
S. Krishna Padmanabhan, Pfizer Inc.; Scott Berry, Berry Consultants, LLC; Vladimir Dragalin, Pfizer Inc.; Michael Krams, Pfizer Inc.
5:05 PM
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Assessing the Causal Effect of Treatment Dosages in the Presence of Self-Selection
Xin Gao, University of Michigan; Michael R. Elliott, University of Michigan
5:05 PM
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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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Development of Imaging Biomarkers for Clinical Trials: Applications in Glioblastoma Multiforme
Hyun (Grace) Kim, University of California, Los Angeles; Jing Huo, University of California, Los Angeles; Matt Brown, University of California, Los Angeles; Jonathan Goldin, University of California, Los Angeles
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Harmonic Regression Analysis of Periodic Time Series Data from Clinical Trials
Michael T. Gaffney , Pfizer Inc.; Martin O. Carlsson, Pfizer Inc.; Kelly H. Zou, Pfizer Inc.
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Development of Imaging Biomarkers for Clinical Trials: Applications in Rheumatoid Arthritis
Grace S. Park, Amgen 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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A Simulation Study to Evaluate Dose-Response in Dose-Titration Clinical Trials: A Dynamic Linear Mixed Effect (DLME) Modeling Approach
Xu Steven Xu, Johnson & Johnson; Min Yuan, Fudan University, China; Julia Wang, Johnson & Johnson; Partha Nandy, Johnson & Johnson
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Analysis of Statistical Tests to Compare Cumulative Proportion of Responders for Pain Data in Clinical Trials
Song Wang, PPD, Inc.
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The Use of Contrast-Enhancing Lesions to Predict Imminent Relapse: Validating Cutter's Rule
Charity Johanna Morgan, The University of Alabama at Birmingham; Ashutosh Ranjan, The University of Alabama at Birmingham; Gary Cutter, University of Alabama at Birmingham
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Competing Risks Methods in Safety Analysis of Oncology Clinical Trials
Sofia Paul, Novartis Pharmaceuticals Corporation; Bingqing Zhou, The University of North Carolina at Chapel Hill; Samit Hirawat, Novartis Pharma; Glen Laird, Novartis Pharmaceuticals Corporation
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A Bootstrap Approach to Estimating Antibody Levels in Case of Non-Normal Data
Roger Maansson, Merck & Co., Inc.
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Implementation of EWOC (Escalation With Overdose Controls) Adaptive Dose-Finding Design in a Phase IIA Clinical Trial
Catherine Bresee, Oschin Comprehensive Cancer Institute; Amir Steinberg, Oschin Comprehensive Cancer Institute; Jeremy Rudnick, Oschin Comprehensive Cancer Institute; Andre Rogatko, Oschin Comprehensive Cancer Institute
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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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Comparisons of Methods in Phase I Dose-Escalation Clinical Trial Designs
Liping Huang, Bayer HealthCare Pharmaceuticals
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A General Framework of Adaptive Designs for Early-Phase Oncology Clinical Trials
Lixin Lang, Bristol-Myers Squibb; Ralph Raymond, Bristol-Myers Squibb
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Using Pilot Study for Clinical Study Planning
Hongbin Gu, The University of North Carolina at Chapel Hill; Xiaofei Wang, Duke University
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Decisionmaking in Post Clinical Trials
Heping Zhang, Yale University
8:35 AM
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How to Define Regions in Multiregional Clinical Trials
Qi Zhang, Eli Lilly and Company; Yoko Tanaka, Eli Lilly and Company
8:35 AM
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Relative Power and Robustness of Mixed Model, GEE, and MMRM Analysis of Alzheimer's Disease Treatment Trials
Steven D. Edland, University of California, San Diego
8:35 AM
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Futility Assessment Utilizing Conditional Power in a Phase III Clinical Trial
Yan Sun, Amgen Inc.
8:35 AM
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Time-Variant Response Patterns and Modeling Precise Assessment Time in Confirmatory Clinical Trials
Yoko Tanaka, University of Pittsburgh Graduate School of Public Health
8:50 AM
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Operational Characteristics of a Go/No-Go Decision Rule in an Early Clinical Trial
Atalanta Ghosh, Johnson & Johnson; Jose Carlos Pinheiro, Johnson & Johnson; Paul Rothenberg, Johnson & Johnson
8:50 AM
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Multinational Clinical Trials: A Perspective from Latin America
Carolina Cernadas, Schering Plough Argentina
8:55 AM
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Evaluating personalized treatment strategies: Subset analyses do not avoid the loss of power due to subgroups with no treatment effect
Werner Vach, Institute of Medical Biometry and Medical Informatics; Rene dePont Christensen, University of Southern Denmark; Oke Gerke, Odense University Hospital
8:55 AM
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Optimization of Error Spending Approach in Clinical Trials
Michael Baron, The University of Texas at Dallas; Yi Zhong, The University of Texas at Dallas
9:05 AM
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Evaluation of Multiregional Clinical Trials: Statistical and Other Issues in Each Development Stage
Yuki Ando, Pharmaceuticals and Medical Devices Agency
9:15 AM
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Variability Exploration in Six Phase III Diabetes Clinical Trials: Implications for Research Studies
Hua Guo, Merck Research Laboratories; Bret Musser, Merck Research Laboratories
9:20 AM
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Conditional Power and Predictive Power Approaches to Interim Monitoring in Equivalence Trials
Xiaojiang Zhan, Merck & Co., Inc.
9:20 AM
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EWOC Online: A Novel Web Application for Computing a Bayesian Phase I Design Method for Dose-Finding with Escalation with Overdose Control
Dror Berel, Cedars-Sinai Medical Center; Andre Rogatko, Oschin Comprehensive Cancer Institute
9:35 AM
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Optimal Two-Stage Phase II Design Utilizing Partial Information for Long-Term Endpoints
Bo Huang, Pfizer Inc.; Enayet Talukder, Pfizer Inc.; Neal Thomas, Pfizer Inc.
9:35 AM
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Evaluation of Common Statistical Methods in Randomized Delayed-Start Design of Progression Disease Clinical Trials
Bongin Yoo, Bristol-Myers Squibb; Thomas Kelleher, Bristol-Myers Squibb
9:35 AM
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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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Clinical Trial Designs for Predictive Biomarker Validation: Theoretical Considerations and Practical Challenges
Daniel Sargent, Mayo Clinic; Sumithra Mandrekar, Mayo Clinic
10:35 AM
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A Case Study of Using a Genomic Assay to Predict the Benefit of Chemotherapy in Treating Breast Cancer: Testing, Prediction, and Study Planning
William E. Barlow, Cancer Research and Biostatistics (CRAB); Carl Yoshizawa, Genomic Health, Inc.
11:00 AM
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Measuring the Performance of Markers Used to Select Patient Treatment
Holly Janes, Fred Hutchinson Cancer Research Center
11:25 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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Assessing the Impact of Partial Monitoring on Power Within Clinical Trials
Joe William Bero, Boston Scientific Corporation
2:45 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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Performance Characteristic of Sequential Probability Ratio Test (SPRT) for Data Monitoring Committee (DMC) Review in Drug-Eluting Stent Clinical Trials
Yun Lu, Boston Scientific Corporation; Huyuan Yang, Boston Scientific Corporation
3:05 PM
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Tuesday, 08/03/2010
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The Accuracy of Clinical Trial Inferences: The Saw Palmetto Experience
Jeannette Y. Lee, University of Arkansas for Medical Sciences; Page Moore, University of Arkansas for Medical Sciences; Shelly Lensing, University of Arkansas for Medical Sciences
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Design, Implementation, and Results for a Bayesian Adaptive Randomization Trial for Targeted Therapy in Lung Cancer
Suyu Liu, MD Anderson Cancer Center; J. Jack Lee, MD Anderson Cancer Center
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Statistical Programmers in the Pharmaceutical Industry
Chengying (Nancy) Wu, sanofi-aventis
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Using Historical Data for a Transitional Decision of Single-Arm Phase II Clinical Trials
Zunqiu Chen, Oregon Health & Science University; Yiyi Chen, Oregon Health & Science University; Motomi Mori, Oregon Health & Science University
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Hierarchical Testing Procedures for Secondary Endpoints in Clinical Trials
Thomas Kelleher, Bristol-Myers Squibb
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Optimizing a Testing Procedure Based on Kernel Density Estimation for Comparing Two Treatments
Sibabrata Banerjee, Merck & Co., Inc.; Sunil Dhar, New Jersey Institute of Technology; Farid Kianifard, Novartis Pharmaceuticals Corporation; Hanzhe Zheng, Merck & Co., Inc.; Venkata Sasikiran Goteti, Merck & Co., Inc.
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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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Balancing Informativeness and Ethics in Clinical Trial Design
Valerii Fedorov, GlaxoSmithKline
8:35 AM
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Personalized Medicine Trials in Non-Small Cell Lung Cancer
Michael Kosorok, The University of North Carolina at Chapel Hill; Yufan Zhao, Amgen Inc.; Donglin Zeng, The University of North Carolina at Chapel Hill; Mark Socinski, The University of North Carolina at Chapel Hill
9:00 AM
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A Multilevel Modeling Approach to Investigating Treatment Effect Variability in Randomized Longitudinal Experiments
Joseph Rausch, University of Cincinnati College of Medicine/Cincinnati Children's Hospital
9:15 AM
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Application of Bayesian Joint Modeling of Time-to-Event and Patient-Reported Outcomes in an Oncology Clinical Trial
Luping Zhao, Eli Lilly and Company; Wei Shen, Eli Lilly and Company; Haoda Fu, Eli Lilly and Company ; Michelle Denise Hackshaw, Eli Lilly and Company; Mark E. Boye, Eli Lilly and Company
9:15 AM
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A Case Study of Issues with Subgroup Analysis for Medical Devices
Yao Huang, FDA/CDRH; Yunling Xu, FDA/CDRH
9:15 AM
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Estimation of Treatment Effect Following a Clinical Trial with Adaptive Design
Xiaolong Luo, Celgene Corporation; Peter Ouyang, Celgene Corporation
9:20 AM
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Propensity Score Matching in Randomized Clinical Trials
Zhenzhen Xu, University of Michigan; John David Kalbfleisch, University of Michigan
9:20 AM
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A Graphical Approach to Multiple Test Procedures for Adaptive Phase II/III Clinical Trials
Martin Posch, Medical University of Vienna
9:25 AM
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Admissibility of Naive Estimator Under LINEX Loss in a Two-Stage Design
AnqiI Sun, University of Florida; Mark Yang, University of Florida
10:05 AM
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Use of Graphics in Clinical Trials
Frank E. Harrell, Jr., Vanderbilt University School of Medicine
10:35 AM
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Sample Size Re-estimation in Crossover Trials
Adina Soaita, Pfizer Inc.; Byron Jones, Pfizer Inc.; Jerry J. Weaver, Pfizer Inc.
10:35 AM
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Meta-Analysis for Rare Adverse Event Data from Clinical Trials
Brenda Crowe, Eli Lilly and Company
10:35 AM
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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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Evaluating Cardiovascular Risk in Diabetes Clinical Trials: Lessons Learned from Saxagliptin
J Mark Donovan, Bristol-Myers Squibb
10:35 AM
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A Case Study of Graphics in Clinical Trials: The Role of Statistical Graphics in the Recent Submission/Approval of GSK's Votrient in the United States
Michael Durante, GlaxoSmithKline
10:55 AM
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Handling Missing Data in Rheumatoid Arthritis Trials
Guoguang Ma, Amgen Inc.; Liyun Ni, Amgen Inc.; Ling Chen, Washington University School of Medicine
11:05 AM
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Change-Point Analysis of Survival Data with Application in Clinical Trials
Xuan Chen, sanofi pasteur; Michael Baron, The University of Texas at Dallas
11:05 AM
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Graphics for Exploratory Analysis and Reporting in Clinical Trials
Michael O'Connell, Tibco
11:15 AM
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Evaluating Cardiovascular Risk in Diabetes Clinical Trials: An FDA Statistician's Perspective
Jon Todd Sahlroot, FDA
11:15 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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Communicating Clinical Trial Results the Statistical Graphic Way
Mat Soukup, FDA
11:35 AM
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A Hybrid Geometric Select-and-Test Design Based on Treatment Failure Time and Toxicity
Peter F. Thall, MD Anderson Cancer Center
2:05 PM
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An Improved Method for Testing Two Families of Endpoints
Haihong Li, Vertex Pharmaceuticals; Abdul J. Sankoh, Vertex Pharmaceuticals
2:05 PM
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Missing Data in Clinical Trials
Herbert Thijs, I-Biostat
2:05 PM
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Genes Selection and Components Retention for Supervised Survival Prediction Models
Keyue Ding, Queen's University
2:05 PM
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Strategies for Global Drug Development: Bridging vs. Multiregional Clinical Trials
William Wang, Merck & Co., Inc.; William Malbecq, Merck & Co., Inc.
2:05 PM
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Optimal Phase II Decision Rules in a Seamless PhaseII/III Clinical Trial
Bo Jin, Merck Research Laboratories
2:05 PM
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Multiple Testing Problems with General Logical Restrictions in Clinical Trials
Alex Dmitrienko, Eli Lilly and Company; Ajit C. Tamhane, Northwestern University
2:20 PM
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Missing Data in a Large Long-Term Clinical Trial: A Case Study
Dacheng Liu, Boehringer Ingelheim Pharmaceuticals, Inc.
2:25 PM
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Who Needs Bayesian Phase I Trials?
Rick Chappell, University of Wisconsin-Madison
2:30 PM
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Generalized Hypothesis Testing in Interim Treatment Selection with a Flexible Selection Margin
Yujun Wu, Sanofi-Aventis; Peng-Liang Zhao, sanofi-aventis
2:35 PM
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Evaluating Statistical Methods to Establish Clinical Similarity of Two Biologics: A Real-Life Example
Lei Lei, Amgen Inc.
2:45 PM
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Principal Stratification Methods for Evaluating Immunological Surrogate Endpoints in a Vaccine Efficacy Trial
Peter Gilbert, Fred Hutchinson Cancer Research Center
2:45 PM
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Exploration of Regional Impact on Efficacy Data in Antidepressant Clinical Trials
Peiling Yang, FDA
2:45 PM
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Regulatory and Statistical Issues in Multiregional Trials: Case Studies
Daphne T.Y. Lin, FDA; Greg Soon, CDER/FDA; Wen Zeng, FDA
3:05 PM
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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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Evaluation of Regional Treatment Effect in a Multiregional Clinical Trial
Yi Tsong, CDER/FDA; W-J Chang, National Health Research Institutes, Taiwan; Chin-Fu Hsiao, National Health Research Institutes, Taiwan; Hsiao-Hui Tsou, National Health Research Institutes, Taiwan
3:25 PM
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Addressing the Missing Data Problem in Clinical Trials
Linda Yau, Genentech
3:25 PM
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Wednesday, 08/04/2010
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gsDesign Explorer: Easy-to-Use Open Source GUI- and R-Based Group Sequential Design Software
Keaven M. Anderson, Merck Research Laboratories; William Constantine, REvolution Computing; Jason B. Clark, Merck Research Laboratories
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Multiplicity Adjustment in Clinical Trials
Annpey Pong, Merck & Co., Inc.
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Handling of Missing Data in Clinical Trials: Findings of a National Research Council Study
Roderick Joseph Little, University of Michigan
8:35 AM
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Efficient Early Phase Designs in Oncology Based on Evidence Synthesis
Jyotirmoy Dey, Novartis Pharmaceuticals Corporation; Wentao Feng, Novartis Pharmaceuticals Corporation
8:35 AM
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The Case for Embedding a Detailed Statistical Analysis Plan in Clinical Trial Protocols
Chris Assaid, Merck Research Laboratories; Keaven M. Anderson, Merck Research Laboratories
8:35 AM
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On the Use of Historical Information in Selecting Design Type for Phase II Oncology Trials
Yiyi Chen, Oregon Health & Science University; Rongwei (Rochelle) Fu, Oregon Health & Science University; Zunqiu Chen, Oregon Health & Science University
8:35 AM
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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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Choice of Estimand, Trial Design, and Trial Conduct
James D. Neaton, University of Minnesota
9:00 AM
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Forecasting Clinical Trial Enrollment: A Case Study
Zachary Skrivanek, Eli Lilly and Company
9:05 AM
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Testing Small Center Events in Multicenter Trials Using Survival Modeling
Usha Sita Govindarajulu, Brigham and Women's Hospital, Harvard Medical School; Elizabeth J. Malloy, American University; James Dziura, Yale University
9:05 AM
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Application of Methods for Assessing Risk-Benefit in Clinical Trials
Menghui Chen, Merck & Co., Inc.; Shailaja Suryawanshi, Merck & Co., Inc.
9:05 AM
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Accuracy of Biomarker Testing and Its Impact on Targeted Therapy Validation
Meijuan Li, FDA; Estelle Russek-Cohen, FDA; Rong Tang, FDA
9:15 AM
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Bayesian Adaptive Phase II/III Clinical Trial Design Using the Relationship Between Tumor Response and Survival
Donald Arthur Berry, MD Anderson Cancer Center; Haiying Pang, MD Anderson Cancer Center
9:20 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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A 'Paradox' in the Use of an ANCOVA Model in Determination of Treatment Effect in Clinical Trials
Chi-Hse Teng, Amylin Pharmaceuticals; Larry Z. Shen, Amylin Pharmaceuticals; Ping Yan, Amylin Pharmaceuticals
9:35 AM
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Evaluating Diagnostics Hypotheses in Proof-of-Concept Clinical Trials
Jane Fridlyand, Genentech
9:55 AM
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The Advantageous Adaptive Randomization in Clinical Trials
Bob Zhong, Johnson & Johnson
10:35 AM
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Key Considerations for Simulations to Optimize Dose-Finding Trials
Natalie Cheung Hall, Eli Lilly and Company
10:35 AM
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An Adaptive Futility Monitoring Method with Time-Varying Conditional Power Boundary
Ying Zhang, The University of Iowa; William Clarke, The University of Iowa
10:55 AM
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A Theory for Testing Hypotheses Under Covariate-Adaptive Randomization
Jun Shao, University of Wisconsin-Madison; Xinxin Yu, University of Wisconsin-Madison; Bob Zhong, Johnson & Johnson
10:55 AM
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A Statistical Design for Investigating Skin Diffusion-Based Dose Response in Humans
Jihao Zhou, Allergan Pharmaceuticals, Inc.; Thomas Lin, Allergan Pharmaceuticals, Inc.; Susan Guo, Allergan Pharmaceuticals, Inc.; Barbara Scholz, Allergan Pharmaceuticals, Inc.
11:05 AM
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A Bayesian Design for a Proof-of-Concept Study Comparing Rituxan in Combination with a New Drug to Rituxan Alone
Sharon C. Murray, GlaxoSmithKline; John F. Toso, GlaxoSmithKline; John W. Bauman, GlaxoSmithKline;
11:15 AM
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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
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A Hybrid Frequentist-Bayesian Approach to a Pilot Study
Nicole Blackman, GlaxoSmithKline
11:55 AM
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Hierarchical Gaussian Power Prior Models for Adaptive Incorporation of Historical Information in Clinical Trials
Bradley P. Carlin, University of Minnesota; Brian P. Hobbs, University of Minnesota; Daniel Sargent, Mayo Clinic; Sumithra Mandrekar, Mayo Clinic
2:05 PM
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Statistical Testing in Clinical Trial with Covariate Adaptive Randomization
H.M. James Hung, FDA; Sue-Jane Wang, FDA
2:05 PM
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Sequential Design of Phase II--III Cancer Trials
Tze Leung Lai, Stanford University; Philip Lavori, Stanford University; Mei-Chiung Shih, Stanford University
2:05 PM
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Bias in Oncology Time-to-Event Data Analysis
Din Chen, Georgia Southern University; Yuhlong Lio, The University of South Dakota; Yibin Wang, Novartis
2:05 PM
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Comparing the Performance of Composite Endpoints and Responder Definitions with a Unified Modeling Framework for Multiple Endpoints Within Clinical Trials
David Andrae, PPD, Inc.
2:20 PM
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Combining Information Across Studies for Clinical Trials: What We Have Learned at FDA's Center for Devices and Radiological Health
Laura Thompson, FDA/CDRH
2:30 PM
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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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Case Study: Benefits of an Adaptive Clinical Trial Design in Oncology
Darcy Hille, Merck & Co., Inc.; Christine K. Gause, Merck Research Laboratories; Jason B. Clark, Merck Research Laboratories; Sarah Hoagey, Merck & Co., Inc.; Keaven M. Anderson, Merck Research Laboratories
2:50 PM
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Predictive Probability Approach for the Design and Analysis of Response and Toxicity Data in Cancer Clinical Trials
J. Jack Lee, MD Anderson Cancer Center; Guosheng Yin, The University of Hong Kong; Nan Chen, M D Anderson Cancer Center
2:55 PM
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Weighted Randomization Test for Multi-Arm Randomized Clinical Trials
Feifang Hu, University of Virginia
3:05 PM
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Strategies for Setting Up the Logistics in Early Phase Adaptive Design Clinical Trials
Eva R. Miller, ICON Clinical Research
3:05 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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Expected Frequency of Allowed Forced Allocations in a Multicenter Clinical Trial
Suvajit Samanta, Merck Research Laboratories; Olga Kuznetsova, Merck Research Laboratories
3:20 PM
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Adding a Prediction Interval Futility Analysis to a Group Sequential Trial
John Loewy, ARIAD Pharmaceuticals; David Dorer, ARIAD Pharmaceuticals
3:25 PM
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Effect of Patient Allocation Schemes on the Power of a Test for Treatment Effect
Fanni Natanegara, Eli Lilly and Company; Christel Faes, Hasselt University; Geert Molenberghs, I-BioStat; Craig Mallinckrodt, Eli Lilly and Company
3:35 PM
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Thursday, 08/05/2010
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Maximizing the Longitudinal Rate of Change with Multiple Outcome Measures to Improve the Design of Clinical Trials on Alzheimer's Disease
Chengjie Xiong, Washington University
8:35 AM
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Biomarkers in Clinical Trials in the Development of Biologics and Risk Assessment
Samir Lababidi, FDA
8:50 AM
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Calibration in the Continual Reassessment Method for Phase I Clinical Trials
Shing M. Lee, Columbia University; Ying Kuen Cheung, Columbia University
8:50 AM
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Bayesian Adaptive Designs in Practice
Scott Berry, Berry Consultants, LLC; Jason Connor, Berry Consultants, LLC
9:00 AM
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Considerations on the Study Design and Analysis of Vulvar and Vaginal Atrophy Studies
Ling Chen, FDA
9:05 AM
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Exploring the Relationship Between UGT1A1 Genotypes in Maternal Blood and Infant Blood Samples and Bilirubin Levels in a Clinical Trial of Pregnant Women Treated with Boosted ATV
Wenhua Hu, Bristol-Myers Squibb; Victoria Wirtz, Bristol-Myers Squibb; Eric Vandeloise, Bristol-Myers Squibb; Stjohn McGrath, Bristol-Myers Squibb; Timothy Eley, Bristol-Myers Squibb; Awny Farajallah, Bristol-Myers Squibb; Shu-Pang Huang, Bristol-Myers Squibb
9:20 AM
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Using Cardiovascular Disease Risk Functions in Public Health and Clinical Trial: The Framingham Study Experience
Ralph B. D'Agostino, Sr., Boston University
9:25 AM
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Regulatory Considerations for Addressing Multiplicity Problems of Clinical Trials with Multiple Endpoints
Mohammad F. Huque, FDA
10:35 AM
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Bayesian Hierarchical Models for Detecting Safety Signals in Clinical Trials
Haijun Ma, Amgen Inc.; Amy Xia, Amgen Inc.; Bradley P. Carlin, University of Minnesota
10:35 AM
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Using Integrated Difference Between Two Kaplan-Meier Curves for Quantifying Treatment Contrast in Comparative Clinical Trials with Event Time Observations
Lihui Zhao, Harvard School of Public Health
10:35 AM
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CTDesignExplorer: An Action Queue--Based Open-Source Simulation Experiment Platform for Evaluating Clinical Trial Designs
Yuanyuan Wang, University of Pittsburgh; Roger Day, University of Pittsburgh; Daniel Normolle, University of Pittsburgh
10:50 AM
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Power Analyses for Negative Binomial Models with Application to Multiple Sclerosis Clinical Trials
Mallikarjuna Rettiganti, The Ohio State University; Haikady Nagaraja, The Ohio State University
10:50 AM
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Quantifying the Cost in Power of Ignoring Covariate Imbalances in Clinical Trial Randomization
Jody Dyan Ciolino, Medical University of South Carolina; Wenle Zhao, Medical University of South Carolina; Yuko Y. Palesch, Medical University of South Carolina; Renee' Martin, Medical University of South Carolina
10:50 AM
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Industry Perspective on the FDA Guidance on Multiplicity Issues
Walter W. Offen, Eli Lilly and Company
11:00 AM
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Challenges in the Conduct of Clinical Trials in the Australasian Region
Val Gebski, University of Sydney
11:05 AM
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The Use of Nomogram Predictions as Comparators for Adjuvant Treatment Studies in Prostate Cancer
Zhenyu Jia, University of California, Irvine; James Koziol, The Scripps Research Institute; Michael Lilly, University of California, Irvine; Dan Mercola, University of California, Irvine
11:05 AM
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Trajectory of Postpartum Depression Screening Scores
Peter C. Wollan, Olmsted Medical Center; Barbara P. Yawn, Olmsted Medical Center
11:05 AM
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Experience with Using Simulation Models to Plan for Drug Supply in Adaptive Trials
Nitin R. Patel, Cytel Inc.; Suvajit Samanta, Merck Research Laboratories; Pralay Senchaudhuri, Cytel Inc.; Christine Stocklin, Merck & Co., Inc.
11:15 AM
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Methods to Test Treatment-by-Site Interaction Using Mediated Moderation: An Application to the TORDIA Clinical Trial
Kaleab Abebe, University of Pittsburgh; Satish Iyengar, University of Pittsburgh; David A. Brent, University of Pittsburgh
11:20 AM
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Variations of and Types of Statistical Control for Multiplicity in Clinical Trials: The Academic Perspective
Joseph Massaro, Boston University; Ralph B. D'Agostino, Sr., Boston University
11:25 AM
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Multiplicity in Clinical Trials: A European Perspective
Norbert Benda, BfArM; Joachim Roehmel , Institute for Prevention Research and Social Medicine
11:50 AM
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