JSM 2005 - Toronto

Abstract #303875

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Activity Number: 15
Type: Topic Contributed
Date/Time: Sunday, August 7, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303875
Title: The Effects of Multiple Testing on Operating Characteristics when All Tests Must Be Passed
Author(s): Jeng Mah*+ and Peter L. Chen and Dong Li
Companies: Guidant Corporation and Guidant Corporation and Guidant Corporation
Address: MS F321, St Paul, MN, 55112-5798, United States
Keywords: multiple testing ; Type I error ; power ; combined error rate
Abstract:

Statistical hypothesis testing has become a standard practice in scientific decisionmaking. Significance level, p-value, and power are common terms used by scientists and researchers across all disciplines. In clinical trials, data often are analyzed multiple times or used to answer multiple questions. The effects of multiple decisions on probability of familywise error (FWE) have been studied extensively. Most statistical methodologies treat multiple decisions made in a single study individually (i.e., inferences are drawn from all positive results; an FWE-I is committed when any null hypothesis is rejected wrongfully). FWE-I rate is inflated with this multiple decision process, a process analogous to a series configuration of the type-I error events. Medical device trial often requires the passing of all tests evaluating individual components of a system. FWE-I is committed only when all null hypotheses are rejected---a parallel configuration on the type-I error events. We examined the effects of parallel type-I error on overall decisions. Specifically, we explored merits and challenges in controlling a combined FWE-I and FWE-II rate of a study prespecified in the study design.

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Revised March 2005