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17 * ! Sun, 8/8/2021, 1:30 PM - 3:20 PM Virtual
Innovative Statistical Strategies and Designs in Oncology Drug Development — Topic-Contributed Papers
Biopharmaceutical Section, Biometrics Section, International Chinese Statistical Association
Organizer(s): Olga Marchenko, Bayer
Chair(s): Qi Jiang, Seagen
1:35 PM Opportunities and Challenges of Master Protocol Trials: ASA Oncology Working Group Master Protocol Subteam Update
Xiaoyun (Nicole) Li, Merck & Co.; Chengxing (Cindy) Lu, Biogen
1:55 PM Application of Historical Data in Oncology Combination Therapy Development
Rong Liu, Bristol Myers Squibb
2:15 PM Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker Selected Populations in Oncology Confirmatory Trials
Sunhee Ro, Sierra Oncology
2:35 PM Discussant: Xin Cindy Gao, FDA
2:55 PM Floor Discussion