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

Abstract Details

Activity Number: 408
Type: Contributed
Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308722
Title: Optimal Phase II Decision Rules in a Seamless PhaseII/III Clinical Trial
Author(s): Bo Jin*+
Companies: Merck Research Laboratories
Address: , , PA, 18977, USA
Keywords: seameless phase II/III trial ; utility function ; non-inferiority
Abstract:

In this presentation, we consider a seamless trial where one of a number of experimental treatments is selected in the phase II stage then tested in the phase III stage. Particularly we are interested in the optimal decision rules under the case where a number of criteria are considered in the phase II stage. A utility function is proposed to incorporate these criteria and the optimal decision rule is to select the smallest utility score. A case study is presented for a seamless phase II/III fixed dose combination non-inferiority trial where the phase II is to select the best formulation.


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