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

Abstract Details

Activity Number: 409
Type: Contributed
Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307757
Title: A Gatekeeping Multiple Comparison Procedure Based on the Hommel Test for Clinical Trials with Hierarchically Ordered Objectives
Author(s): Thomas Brechenmacher*+ and Jane Xu and Alex Dmitrienko and Ajit C. Tamhane
Companies: Dainippon Sumitomo Pharma Co., Ltd. and Dainippon Sumitomo Pharma America, Inc. and Eli Lilly and Company and Northwestern University
Address: Data science department Biostatistics group, Osaka, International, 564-0053, Japan
Keywords: Multiple testing ; Gatekeeping procedure ; Hommel test ; Closed testing ; Clinical trials ; Hierarchical objectives

When conducting clinical trials with hierarchically ordered objectives composed of multiple treatment comparisons, it is essential to use multiplicity adjustment methods to control the familywise error rate in the strong sense while taking into account the hierarchical structure of the hypotheses. To address this issue, a gatekeeping procedure based on the Hommel test is proposed and is shown to yield more statistical power compared to similar methods already available in the literature (Dmitrienko, Tamhane. Mixtures of multiple testing procedures for gatekeeping applications in clinical trials. Statistics in Medicine). A general description of the procedure is given and details are presented on how it can be applied to complex clinical trial designs by setting up highly flexible logical restrictions. Two clinical trial examples are given to illustrate the methods.

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