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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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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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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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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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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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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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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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Multinational Clinical Trials: A Perspective from Latin America
Carolina Cernadas, Schering Plough Argentina
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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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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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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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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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 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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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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Use of Graphics in Clinical Trials
Frank E. Harrell, Jr., Vanderbilt University School of Medicine
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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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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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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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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Who Needs Bayesian Phase I Trials?
Rick Chappell, University of Wisconsin-Madison
2:30 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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