JSM 2004 - Toronto

Abstract #300848

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Activity Number: 29
Type: Contributed
Date/Time: Sunday, August 8, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300848
Title: Fallback and Gatekeeping Strategies for Primary and Secondary Endpoints
Author(s): Brian L. Wiens*+ and Alexei Dmitrienko and Peter H. Westfall
Companies: Amgen, Inc. and Eli Lilly and Company and Texas Tech University
Address: m/s 24-3-C, Thousand Oaks, CA, 91320-1799,
Keywords: closed test ; multiple comparisons ; power
Abstract:

Clinical trials that pre-specify multiple endpoints require strategies to control the Type I error rate. One tactic is to classify endpoints as primary or secondary, but this alone is insufficient. A number of methods have been proposed, including fixed-sequence testing, Bonferroni adjustments, and gatekeeper approaches. A fallback procedure, which uses a fixed-sequence testing approach while always allowing for testing of all hypotheses, will be discussed. Parallel gatekeeper strategies can be used to control the Type I error rate for multiple primary endpoints while allowing consideration of secondary endpoints if at least one primary endpoint is significant. We compare and contrast these two methods. Representing each strategy as a closed testing procedure allows for evaluation and comparison, and for consideration of improvements in power without inflating the Type I error rate. Combining the two strategies is also explored.

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Revised March 2004