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148 * ! Tue, 8/10/2021, 10:00 AM - 11:50 AM Virtual
Considerations in Clinical Trial Endpoints’ Selection — Invited Papers
Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section, Caucus for Women in Statistics
Organizer(s): Freda Cooner, Amgen
Chair(s): Laura Fernandes, FDA
10:05 AM Treatment-Free Survival and Depth of Response as Novel Endpoints of Immuno-Oncology (IO)-Based Therapy for Metastatic Renal Cell Carcinoma (MRCC)
Meredith M Regan, Dana-Farber Cancer Institute; Laura Fernandes, FDA
10:30 AM Handling Missing Data Through Combining of Endpoints
Jitendra Ganju, Ganju Clinical Trials, LLC; Ron Yu, Gilead Sciences
10:55 AM Win Statistics: Impact of Follow-up Time and Unbiased Estimators of Treatment Effect in the Presence of Censoring
Gaohong Dong, BeiGene; Victoria Chang, BeiGene; Bo Huang, Pfizer Inc.; James Song, BeiGene; Duolao Wang, Liverpool School of Tropical Medicine, UK; Lu Mao, University of Wisconsin; Jiuzhou Wang, ImmunoGen Inc.; Johan Verbeeck, University Hasselt, Belgium ; Margaret Gamalo-Siebers, Pfizer Inc.; David C. Hoaglin, University of Massachusetts Medical School
11:20 AM How to Measure the Treatment Effect in COVID-19 Clinical Studies?
Lu Tian, Stanford University ; LJ Wei, Harvard University; Zachary McCaw, Google Inc
11:45 AM Floor Discussion