Online Program Home
  My Program

All Times EDT

* = applied session       ! = JSM meeting theme

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