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Sunday, 08/01/2010
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Novel Phase I Design for Oncology Research
Linda Sun, Merck & Co., Inc.; Keaven M. Anderson, Merck Research Laboratories; Lisa Lupinacci, Merck & Co., Inc.; Yevgen Tymofyeyev, Merck & Co., Inc.
2:05 PM
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Better Learning About the MTD in Phase I Oncology Trial: A Case Study Implementing Bayesian Design Based on Continuous Reassessment Method
Inna Perevozskaya, Pfizer Inc.
2:25 PM
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Evaluation of Dose-Finding Designs: On the Interplay Between Theory and Simulation
Assaf P. Oron, University of Washington; Peter Hoff, University of Washington
3:05 PM
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Phase I Studies: Goals, Patient Selection, and Implications for Design
Paul H. Frankel, City of Hope; Stephen Shibata, City of Hope; Susan Groshen, University of Southern California, Norris; Jeffrey Longmate, City of Hope; Stella Khoo, City of Hope; Edward Newman, City of Hope
4:05 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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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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Monday, 08/02/2010
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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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Comparisons of Methods in Phase I Dose-Escalation Clinical Trial Designs
Liping Huang, Bayer HealthCare Pharmaceuticals
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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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A Conditional Bayesian Logistic Regression Model (BLRM) with Overdose Control
Lu-May Chiang, Novartis Pharmaceuticals Corporation; Adarsh Joshi, Eli Lilly and Company; David Ohlssen, Novartis Pharmaceuticals Corporation; Jyotirmoy Dey, Novartis Pharmaceuticals Corporation
9:05 AM
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Adaptive Factorial Designs for Combination Therapy in Oncology
Donald Arthur Berry, MD Anderson Cancer Center
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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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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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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Tuesday, 08/03/2010
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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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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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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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Nonparametric Profile Monitoring by Mixed Effects Modeling
Peihua Qiu, University of Minnesota
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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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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Confidence Intervals for the Selected Treatment Effect in Multistage Adaptive Designs
Ionut Bebu, Georgetown University Medical Center; Vladimir Dragalin, Pfizer Inc.; George Luta, Georgetown University
3:20 PM
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Wednesday, 08/04/2010
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A Nonparametric Change Point Model for Multivariate Phase II Statistical Process Control
Mark David Holland, University of Minnesota; Douglas Hawkins, University of Minnesota
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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Phase I Dose-Finding in Cancer Trials Based on a Discrete Time Multistate Model
Lin Yang, MD Anderson Cancer Center; Nebiyou Bekele, MD Anderson Cancer Center; Donald Arthur Berry, MD Anderson Cancer Center
8:50 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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Bayesian Design for Nonrandomized Phase II Oncology Trials
Yanmei Xu, GlaxoSmithKline; Bingming Yi, GlaxoSmithKline
10:55 AM
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Simulation of a Phase III Trial Using Realizations of Posterior Distribution Based on a Phase IIb Trial
A. Lawrence Gould, Merck Research Laboratories
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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The Role of Bayesian Statistics in Confirmatory Drug Development Trials
David Ohlssen, Novartis Pharmaceuticals Corporation
2:30 PM
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Statistical Methods for a Phase II Oncology Trial with a GMI Endpoint
Stephanie Ann Kovalchik, University of California, Los Angeles; William Leonard Mietlowski, Novartis Oncology
3:20 PM
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Thursday, 08/05/2010
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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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Impact of Missing Data on the Analysis of Crossover Data
Anjela Tzontcheva, Merck & Co., Inc.; Mahtab Marker, Merck & Co., Inc.
9:05 AM
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Issues to Consider in Selecting a Response-Adaptive Design for Dose-Finding Experiments
Nancy Flournoy, University of Missouri
9:25 AM
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Design and Trial Operational Considerations for a Phase II Two-Stage Adaptive Trial
Weili He, Merck & Co., Inc.; Madhuja Mallick, Merck & Co., Inc.; Yevgen Tymofyeyev, Merck & Co., Inc.; James A. Bolognese, Cytel Inc.
10:55 AM
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