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Sessions Were Renumbered as of May 19.

CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

346 * Tue, 8/2/2016, 10:30 AM - 12:20 PM CC-W196a
Summarizing Case Studies to Learn from and Improve Adaptive Trial Design and Implementation — Topic Contributed Papers
Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Weili He, Merck
Chair(s): Weili He, Merck
10:35 AM Highpoints of What We Learned from Case Studies of Less Well-Understood Adaptively Designed Trials Eva Miller, InVentiv Health Clinical
10:55 AM Case Study: How Promising Is the VALOR Trial for the Future of Adaptive Designs? Yannis Jemiai, Cytel
11:15 AM Regulatory and Practical Considerations for an Adaptive Trial in the Context of Evaluating a Combination Product: An Example Using Two Human MAbs to Prevent Recurrence of CDI Kenneth Koury, Merck Research Laboratories ; Robert Tipping, Merck Research Laboratories
11:35 AM Discussant: Jerry Schindler, Merck
11:55 AM Discussant: Gregory Levin, FDA
12:15 PM Floor Discussion
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