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515 * Wed, 8/1/2012, 10:30 AM - 12:20 PM CC-Room 24A
Planning and Analysis in Oncology Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Tianle Hu, Eli Lilly and Company
10:35 AM Confidence Interval Estimation of the Response Rate in a Two-Stage Gehan Design Xiaoling Wu, Celgene Corporation
10:50 AM Two-Stage Winner Design with Survival Outcomes: Methods and Features Fang Fang, Bayer Healthcare Pharmaceuticals ; Yong Lin, University of Medicine and Dentistry of New Jersey ; Yunlin Li, K&L Consulting Services, Inc. ; Jay Yang, K&L Consulting Services, Inc. ; Xiaosha Sherman Zhang, Astellas Pharma Global Development, Inc.
11:05 AM Statistical Evaluation of Loewe Additivity Model and Bliss Independence Model Wei Zhao, MedImmune ; Lanju Zhang, MedImmune ; Harry Yang, MedImmune
11:20 AM Changes in Tumor Size as a Continuous Variable in Phase II Trials Rather Than WHO/RECIST Response to Improve Success Rate of Confirmatory Phase III Trials Zhengjia Chen, Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute ; Sungjin Kim, Winship Cancer Institute ; Taofeek K Owonikoko, Emory University ; Zhibo Wang, Winship Cancer Institute ; Suresh S Ramalingam, Emory University ; Dong M Shin, Emory University ; Fadlo R Khuri, Emory University ; Jeanne Kowalski , Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute
11:35 AM Analysis of Time-to-Event Data with Categories of Response Beiying Ding, Amgen, Inc. ; Chunlei Ke, Amgen, Inc.
11:50 AM Analyzing Time-to-Event of Interest: Methods of Competing Risk Analysis Kathy Zhang, Amgen, Inc.
12:05 PM Event Projection and Adaptive Adjustment for Event-Driven Trials Xiaoqiang Xue, Quintiles, Inc.



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