This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 18
Type: Topic Contributed
Date/Time: Sunday, August 1, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307020
Title: Expect the Unexpected: Bayesian Adaptive Dose-Finding Design in Proof-of-Concept Study
Author(s): Feng Liu*+
Companies: GlaxoSmithKline
Address: 709 Swedeland Rd, King of Prussia, PA, 19406, USA
Keywords: Bayesian adaptive ; POC

Proof of concept (POC) studies have been used to make internal decision in pharmaceutical industry before big investment in phase 2b and late phase trial. Compound is developed in GSK to treat in patients with Rheumatoid Arthritis (RA) and a POC study was designed to evaluate the clinical effects compared with placebos. The design consists of two parts, part A: an innovative Bayesian adaptive dose finding design is proposed to understand the dose response and find out optimal dose based on clinical effects of GSK compound over placebos, then efficacy of optimal dose will be confirmed using group sequential design in part B. We will discuss the impact of design by dose escalation rules, choice of models, the dose response curve, and practical issues in clinical studies.

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