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Activity Details

37 * Sun, 7/29/2012, 2:00 PM - 3:50 PM CC-Room 28A
Benefit-Risk Assessment and Risk Management — Contributed Papers
Biopharmaceutical Section
Chair(s): Samir Lababidi, FDA
2:05 PM A New Approach for Evaluating Benefit-Risk in Anticoagulation Studies: a Case Study — Vijay Chauhan, Alpha Stats Inc. ; May Tang, Alpha Stats Inc.
2:20 PM A Counterfactual P-Value Approach for Benefit-Risk Assessment in Clinical Trials Donglin Zeng, The University of North Carolina at Chapel Hill ; Guanghui Wei, Amgen, Inc. ; Joseph Ibrahim, The University of North Carolina at Chapel Hill ; Ming-Hui Chen, University of Connecticut ; Beiying Ding, Amgen, Inc. ; Chunlei Ke, Amgen, Inc. ; Qi Jiang, Amgen, Inc.
2:35 PM Modeling the Probability of Second Cancer in Controlled Clinical Trials Kao-Tai Tsai, Celgene Corporation
2:50 PM Combining Information to Develop a Safety Biomarker Sock-Cheng Lewin-Koh, Genentech ; Nicholas Lewin-Koh, Genentech ; Jacqueline Tarrant, Genentech
3:05 PM Bayesian Safety Monitoring and Stopping Rules with Incorporation of Historical Data in Medical Device Clinical Trials Zengri Wang
3:20 PM Cost-Effectiveness Comparison of Whole Breast Irradiation, Brachytherapy, and No Radiation Treatment in Elderly Patients with Breast Cancer Jing Jiang, MD Anderson Cancer Center ; Jinhai Huo, MD Anderson Cancer Center ; Hui Zhao, The University of Texas School of Public Health ; Weiguo He, The University of Texas School of Public Health ; Benjamin D. Smith, MD Anderson Cancer Center
3:35 PM Estimation of Controlled Direct Effects for Dynamic Treatment Regimes Tomohiro Shinozaki, University of Tokyo ; Yutaka Matsuyama, University of Tokyo ; Satoshi Iimuro, University of Tokyo ; Yasuo Ohashi, University of Tokyo ; Hideki Ito, Tokyo Metropolitan Geriatric Hospital

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