Sessions Were Renumbered as of May 19.
Legend:
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
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
