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

Abstract Details

Activity Number: 73
Type: Contributed
Date/Time: Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308056
Title: Exact Two-Stage Designs for Phase II Clinical Trials with Rank-Based Endpoints
Author(s): Gregory E. Wilding and Guogen Shan*+ and Alan Hutson
Companies: State University of New York at Buffalo and State University of New York at Buffalo and State University of New York at Buffalo
Address: 3435 Main Street, Buffalo, NY, 14214,
Keywords: Clinical trial ; Mann-Whitney test ; Minimax Design ; Nonparametric ; Optimal Design ; Phase II Design
Abstract:

Features common to Phase II clinical trials include limited knowledge of the experimental treatment being evaluated, design components implemented due to ethical considerations, and small to moderate sample sizes as a result of resource constraints. It is for these reasons that there exist many two-stage designs proposed in the literature for use in this context. The majority of these designs are for binary endpoints and based on exact probability calculations, or are for continuous endpoints and root in asymptotic approximations to the null distribution. We present an exact two-stage Mann-Whitney design in the context of Phase II clinical trials and demonstrate the efficiency of the design as compared to competitors. In addition to describing the design, we present tables of decision rules under a variety of assumed realities for use in trial planning.


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