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243 Tue, 8/9/2022, 8:30 AM - 10:20 AM CC-144A
Operational Considerations in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Susan Mayo, Food and Drug Administration, Center for Drug Evaluation
8:35 AM Sample Size Re-Estimation: Timing, Decision Rule, and Study Power
David Li, Eisai; Yan Li , Washington University School of Medicine
8:50 AM Statistical Power of Survival Trials Weakened by COVID-19 Pandemic
Ping Xu, Merck & Co.; Gregory T Golm, Merck & Co.
9:05 AM Efficient Parameter Estimation in Seamless Adaptive Group Sequential Designs
Krishna Padmanabhan, Cytel; Cyrus Mehta, Cytel; Lingyun Liu, Vertex Inc; Pranab Ghosh, Pfizer Inc
9:20 AM Power and Sample Size Calculation for Weighted Log-Rank Tests in Group Sequential Trials
Kaifeng Lu, BeiGene
9:35 AM Empirical Power of Adaptive Long-Term Restricted Mean Survival Time-Based Tests in Contemporary Phase III Cancer Immunotherapy Studies
Miki Horiguchi, Dana-Farber Cancer Institute; Hajime Uno, Dana-Farber Cancer Insitute
9:50 AM Statistical Comparison of Waterfall Plots in Oncology Drug Development
Mo Huang, Merck & Co., Inc.; Linda Sun, Merck & Co, Inc.; Cong Chen, Merck & Co., Inc.
10:05 AM Floor Discussion