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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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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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Monday, 08/02/2010
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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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Analysis of Overall Survival When Length of Treatment and Treatment Switching Are Time-Dependent Outcomes of Oncology Trials
Jinwei Yuan, ICON Clinical Research
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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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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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Adaptive Factorial Designs for Combination Therapy in Oncology
Donald Arthur Berry, MD Anderson Cancer Center
9:15 AM
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A Multistate Modeling and Prediction of Survival Distribution Using Information on Subject's Tumor Response Over Time
Shengyan Hong, MedImmune; Iiya Lipkovich, Eli Lilly and Company; Yan Daniel Zhao, Eli Lilly and Company
9:50 AM
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Semiparametric Regression Inference for Tumor Progression in Cancer Studies
Chen Hu, University of Michigan; Alexander Tsodikov, University of Michigan
11:20 AM
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Statistics in Biopharmaceutical Research: Application of Biomarkers in Drug Development
Aloka Chakravarty, FDA; Mark Rothmann, FDA; Rajeshwari Sridhara , FDA
2:05 PM
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Wednesday, 08/04/2010
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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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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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Stopping Rules for Bayesian Dose-Finding Oncology Trials
Yanqiong Zhang, Sanofi-Aventis; Yi He, sanofi-aventis; Guillaume Marchand, sanofi-aventis; Pierre Mancini, sanofi-aventis; Sandrine Micallef, sanofi-aventis
10:50 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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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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Dose-Escalation Approaches for Two Agents in Early-Phase Oncology Studies
Yevgen Tymofyeyev, Merck & Co., Inc.; Christine K. Gause, Merck Research Laboratories; Keaven M. Anderson, Merck Research Laboratories
11:50 AM
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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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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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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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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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Sensitivity Analysis for PFS
Alicia Zhang, Amgen Inc.; Alan Rong, Amgen Inc.; Ying Tian, Amgen Inc.; Michael Wolf, Amgen Inc.
3:35 PM
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Thursday, 08/05/2010
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Voxelwise Analysis of Imaging Response to Therapy in Neurooncology
Mengye Guo, Dana-Farber Cancer Institute; Jeffrey Yap, Dana-Farber Cancer Institute; Annick D. Van den Abbeele, Dana-Farber Cancer Institute; Nancy U. Lin, Dana-Farber Cancer Institute; Armin Schwartzman, Harvard School of Public Health
8:35 AM
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Adaptive Sample Size Re-Estimation in Oncology Trials
Pralay Mukhopadhyay, Bristol-Myers Squibb
9:20 AM
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Application of the Pattern Mixture Model to Mini Mental Status Exam (MMSE) Scores in a Radiation Therapy Oncology Group (RTOG) Trial for Brain Tumors
Kyounghwa Bae, Radiation Therapy Oncology Group; Seunghee Baek, University of Pennsylvania; James Dignam, Radiation Therapy Oncology Group
9:50 AM
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