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CC = Vancouver Convention Centre   F = Fairmont Waterfront Vancouver
* = applied session       ! = JSM meeting theme

Activity Details

20 * Sun, 7/29/2018, 2:00 PM - 3:50 PM CC-West 214
Statistical Considerations for Using Historical Controls in Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section
Organizer(s): Yeh-Fong Chen, US FDA
Chair(s): George Kordzakhia, US FDA
2:05 PM Using Historical Controls in CNS Clinical Trials
Xiang Ling, FDA/CDER/OTS/OB; Kun Jin, FDA; Hsien-Ming James Hung, PhD, Food and Drug Administration
2:25 PM Designing Trials Using Bayesian Methods with Historical Controls
Michael Sonksen, Eli Lilly and Company
2:45 PM Advancing Methodologies for Clinical Trials Using Historical Control

Min Min, U.S. Food and Drug Administration, CDER/OTS/OB; Yeh-Fong Chen, US FDA
3:05 PM Use of Real-World in Clinical Drug Development

Xiuyu Julie Cong, Boehringer Ingelheim Pharmaceuticals Inc; Susan Wang, Boehringer Ingelheim Pharmaceuticals Inc.
3:25 PM Discussant: Aloka Chakravarty, Office of Biostatistics of CDER/FDA
3:45 PM Floor Discussion