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Activity Number: 404
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305831
Title: Bayesian Adaptive Phase II Trial Combining Proof of Concept and Dose-Finding: Comparison of Potential Models
Author(s): Katherine Kacena and Robert Noble*+ and Ping Chen and Richard A Brigandi
Companies: Aptiv Solutions and Aptiv Solutions and Aptiv Solutions and GlaxoSmithKline
Address: , , ,
Keywords: Bayesian ; adaptive ; dose-response ; dose-finding ; Phase II ; proof of concept

A case study of a Phase II Bayesian adaptive design will be presented. Characteristics of this binary endpoint study include: (1) combination of proof of concept and dose-finding, and (2) potential for the dose-response curve to have a reflection point. Piecewise logistic and other models including e-max models are evaluated and compared as potential response curves.

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