JSM 2005 - Toronto

Abstract #303002

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 389
Type: Topic Contributed
Date/Time: Wednesday, August 10, 2005 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #303002
Title: The Multistage Fallback Test for Clinical Trials with Multiple Objectives
Author(s): Alexei Dmitrienko*+ and Brian Wiens
Companies: Eli Lilly and Company and Amgen, Inc.
Address: 10913 West 144th St, Overland Park, KS, 66221, United States
Keywords: Multiple testing ; Clinical trials ; Gatekeeping strategies ; Fallback test
Abstract:

This presentation introduces a novel approach to controlling the overall Type I error rate in clinical trials with hierarchically ordered multiple objectives (e.g., multiple endpoints). The new approach is based on a generalization of the fallback test proposed by Wiens (Pharmaceutical Statistics, 2003) to the case of multiple families of hypotheses. The main feature of the multistage fallback test is that it enables clinical researchers to carry over a fraction of the overall Type I error rate from the first family to subsequent families of null hypotheses. By allowing accumulation of the Type I error rate within families, more power can be made available to hypotheses tested later in a given family. It will be shown that the multistage fallback test is a closed test and its performance will be compared to that of gatekeeping testing strategies. The proposed fallback testing approach will be applied to the analysis of clinical trials with multiple primary and secondary endpoints as well as dose-ranging clinical trials.

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Revised March 2005