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Sunday, 08/01/2010
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Partnership in New Drug Developments
Ji Zhang, Sanofi-Aventis; Hui Quan, sanofi-aventis; Alex Boddy, sanofi-aventis; Peng-Liang Zhao, sanofi-aventis; Stan Young, National Institute for Statistical Science
2:25 PM
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Adaptive Designs in Dose-Finding Oncology Drug Combination Trials
Yuehui Wu, GlaxoSmithKline; Bingming Yi, GlaxoSmithKline; Yanmei Xu, GlaxoSmithKline
2:45 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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Two-Stage Adaptive Design for Bioequivalence: Methods and Application
Yi-Lin Chiu, Abbott Global Pharmaceuticals Research and Development; Yannis Jemiai, Cytel Inc.; Charles Locke, Abbott Laboratories; Pralay Senchaudhuri, Cytel Inc.
4:25 PM
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Using Bayesian Adaptive Designs for FDA Event Safety Studies
Jason Connor, Berry Consultants, LLC; Scott Berry, Berry Consultants, LLC; Donald Arthur Berry, MD Anderson Cancer Center
4:45 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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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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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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Two-Stage Adaptive Design for Case-Control Genetic Association Studies
Lihan Yan, FDA
9:15 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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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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Achieving the Benefits of Both an Internal Pilot and Interim Analysis in Small Samples
John A. Kairalla, University of Florida; Keith E. Muller, University of Florida; Christopher S. Coffey, The University of Iowa
10:35 AM
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Applications of 'Learn' Phase Adaptive Designs
Jose Carlos Pinheiro, Johnson & Johnson; Chyi-Hung Hsu, Novartis Pharmaceuticals Corporation
2:05 PM
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Adaptive Design for Sample Size Re-estimation in a Medical Device Trial of Spinal Cord Stimulation
Nitzan Mekel-Bobrov, Boston Scientific Corporation
2:05 PM
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Guiding Clinicans Through the EffTox Model
Meagan E. Spychala, Rho, Inc.
2:35 PM
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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
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Tuesday, 08/03/2010
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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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Disparity-Aided Robust and Efficient Inference for Adaptive Designs with Covariates
Anand Vidyashankar, George Mason University
8:35 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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A Bayesian Adaptive Design with Biomarkers for Targeted Therapies
Jens C. Eickhoff, Colorado State University; KyungMann Kim, University of Wisconsin-Madison; Jill M. Kolesar, University of Wisconsin-Madison; Jason R. Gee, Lahey Clinic Medical Center
10:35 AM
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Applying Covariate-Adjusted, Response-Adaptive Randomization to Medical Device Studies
Thomas E. Gwise, FDA; Gene Anthony Pennello, FDA
10:55 AM
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Comparing Adaptive and Traditional Crossover Designs for Dose-Finding Trials
James A. Bolognese, Cytel Inc.; Nitin R. Patel, Cytel Inc.; Byron Jones, Pfizer Inc.
11:15 AM
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Adaptive Designs with Sensitive Subgroup Selection
Yan Daniel Zhao, Eli Lilly and Company; Alex Dmitrienko, Eli Lilly and Company
11:15 AM
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I-SPY2: Identifying Biomarker Signatures for Therapeutic Agents in Neoadjuvant Breast Cancer
Donald Arthur Berry, MD Anderson Cancer Center; Kyle Wathen, MD Anderson Cancer Center; Nebiyou Bekele, MD Anderson Cancer Center; Laura Esserman, University of California, San Francisco
11:35 AM
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Overall FDR Control in a Two-Stage Adaptive Design
Jingjing Chen, Temple University; Sanat K. Sarkar, Temple University
2:20 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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Improving the Interim Analysis Process in Adaptive Design Trials
Xiaoyin Fan, Merck & Co., Inc.; Mary Varughese, Merck & Co., Inc.
2:50 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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Statistical Issues in Adaptive Design
Wei Zhang, FDA/CVM
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Forecasting Clinical Trial Enrollment: A Case Study
Zachary Skrivanek, Eli Lilly and Company
9:05 AM
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On Two-Stage Adaptive Design
Gang Li, Johnson & Johnson; Yining Wang, Johnson & Johnson; Weichung J. Shih, University of Medicine and Dentistry of New Jersey
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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Statistical Inference Following an Adaptive Design for Case-Driven Efficacy Study
Xiaoming Li, Merck Research Laboratories; Ivan S.F. Chan, Merck Research Laboratories; Keaven M. Anderson, Merck Research Laboratories
11:20 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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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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Thursday, 08/05/2010
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Adaptive Designs for Dose-Ranging Studies
Vladimir Dragalin, Pfizer Inc.
8:35 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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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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