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 - #307225
Title: Multiple Testing Problems with General Logical Restrictions in Clinical Trials
Author(s): Alex Dmitrienko*+ and Ajit C. Tamhane
Companies: Eli Lilly and Company and Northwestern University
Address: 10913 West 144th St, Overland Park, KS, 66221, USA
Keywords: Multiple comparisons ; Type I error rate ; Gatekeeping procedures ; Clinical trials

In this presentation we discuss multiple testing problems with general logical restrictions arising in clinical trials. The mixture-based framework can be used to construct gatekeeping procedures that account for complex logical relationships among multiple null hypotheses. These gatekeeping procedures control the familywise error rate in the strong sense and enable trial sponsors to set up powerful procedures based on p-value-based tests (eg, Hochberg-type or Hommel-type tests) or parametric tests (eg, regular and step-down Dunnett tests). The general methodology is illustrated using clinical trials with multiple dose-placebo comparisons and patient populations as well as dose-placebo comparisons and noninferiority/superiority objectives.

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