Legend:
CC = Vancouver Convention Centre
F = Fairmont Waterfront Vancouver
* = applied session ! = JSM meeting theme
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20 *
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Sun, 7/29/2018,
2:00 PM -
3:50 PM
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CC-West 214
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Statistical Considerations for Using Historical Controls in Clinical Trials — Topic Contributed Papers
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Biopharmaceutical Section, Biometrics Section
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Organizer(s): Yeh-Fong Chen, US FDA
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Chair(s): George Kordzakhia, US FDA
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2:05 PM
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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
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2:25 PM
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Designing Trials Using Bayesian Methods with Historical Controls
Michael Sonksen, Eli Lilly and Company
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2:45 PM
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Advancing Methodologies for Clinical Trials Using Historical Control
Min Min, U.S. Food and Drug Administration, CDER/OTS/OB; Yeh-Fong Chen, US FDA
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3:05 PM
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Use of Real-World in Clinical Drug Development
Xiuyu Julie Cong, Boehringer Ingelheim Pharmaceuticals Inc; Susan Wang, Boehringer Ingelheim Pharmaceuticals Inc.
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3:25 PM
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Discussant: Aloka Chakravarty, Office of Biostatistics of CDER/FDA
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3:45 PM
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Floor Discussion
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