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271 * ! Tue, 8/9/2022, 10:30 AM - 12:20 PM CC-207B
Recent Statistical Advances of Handling Nonproportional Hazards in Study Design and Data Interpretation — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section
Organizer(s): Philip He, Daiichi Sankyo
Chair(s): Xiaofei Chen, Sanofi
10:35 AM Hypothesis Testing Under Non-Proportion Hazards: Methodologic Challenges and Interpretations
Jianghua He, University of Kansas Medical Center; Huan Cheng, University of Kansas Medical Center
10:55 AM Adaptive Extension of Group-Sequential Time-to-Event Trials in the Presence of Non-Proportional Hazards
Yue Shentu, Daiichi Sankyo Inc.; Yu Li, Merck & Co; Xieyang Jia, Merck & Co
11:15 AM Delayed Separation of OS and PFS Kaplan Meier Curves Occurs in the Majority of IO Trials: A Meta-Analysis of Phase III Studies with Anti-PD-(L)1 Therapy
Magdalena Watras, AstraZeneca; Philip He, Daiichi Sankyo; Nana Rokutanda, AstraZeneca; Jennifer Stocks, AstraZeneca
11:35 AM Testing and Estimating Treatment Effect in the Presence of Delayed Onset of the Effect for Cancer Immunotherapies
Chang Yu, Vanderbilt University Medical Center; Xiang Huang, Vanderbilt University Medical Center; Hui Nian, Vanderbilt University Medical Center; Philip He, Daiichi Sankyo
11:55 AM Discussant: ZHENZHEN XU, FDA
12:15 PM Floor Discussion