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Activity Details
577 * !
Thu, 8/6/2020,
3:00 PM -
4:50 PM
Virtual
Estimands: Some Perspectives from an FDA Working Group — Topic Contributed Papers
Biopharmaceutical Section , Biometrics Section
Organizer(s): Susan Duke, FDA
Chair(s): Susan Duke, FDA
3:05 PM
Estimands for Use in Pulmonary-Allergy US FDA Regulatory Submissions
Dong-Hyun Ahn, FDA ; Yongman Kim, FDA; Susan Duke, FDA
3:25 PM
Patient-Reported Outcome Time-to-Event Estimands in Lung Cancer Trials: What Is the Question?
Mallorie Fiero, U.S. Food and Drug Administration ; Jessica Roydhouse, Menzies Institute for Medical Research, University of Tasmania; Jonathon Vallejo, FDA; Jiaxi Zhou, FDA; Ting-Yu Chen, FDA; Bellinda King-Kallimanis, FDA; Paul Kluetz, FDA; Rajeshwari Sridhara, FDA
3:45 PM
Safety Estimands: A Regulatory Perspective
Cesar Torres, FDA ; Gregory Levin, FDA; Mat Soukup, FDA; Sai Dharmarajan, FDA; Tae Hyun Jung, FDA; Maria Matilde S. Kam, OTS/CDER, FDA; Bo Li, FDA; Sirisha Mushti, FDA; Therri Usher, FDA; Jialu Zhang, FDA
4:05 PM
Estimands in Clinical Endpoint Bioequivalence Trials
Wanjie Sun, FDA
4:25 PM
Discussant: Estelle Russek-Cohen, Retired FDA
4:45 PM
Floor Discussion
