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45 * ! Sun, 8/8/2021, 3:30 PM - 5:20 PM Virtual
Statistical Methods Utilizing Historical and Real-World Data for Clinical Studies — Topic-Contributed Papers
Biopharmaceutical Section, International Chinese Statistical Association, International Society for Clinical Biostatistics, Caucus for Women in Statistics
Organizer(s): Yuan Ji, The University of Chicago
Chair(s): Tianjian Zhou, Colorado State University
3:35 PM Robust Use of External Control Information in Clinical Trials
Heinz Schmidli, Novartis
3:55 PM Performance of LTMLE in the Presence of Missing Patterns
Sue-Jane Wang, FDA; Zhipeng Huang, FDA
4:15 PM Using Historical Data in Developing Novel Therapies: A Roadmap and Case Studies
Rui (Sammi) Tang, Servier Pharmaceuticals; chenkun wang, vertex pharmarcetical
4:35 PM Single Arm Trials with a Synthetic Control Arm Built from RWD
Peter Mueller, University of Texas Austin; Noirrit Kiran Chandra, University of Texas at Austin; Choudur Lakshminarayan, Teradata Labs/The University of Texas at Austin
4:55 PM Floor Discussion