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Activity Number:
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539
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Type:
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Contributed
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Date/Time:
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Thursday, August 2, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308930 |
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Title:
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Multistage Gate-Keeping Procedures with Clinical Trial Applications
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Author(s):
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Alex Dmitrienko*+ and Ajit Tamhane
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Companies:
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Eli Lilly and Company and Northwestern University
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Address:
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10913 West 144th St, Overland Park, KS, 66221,
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Keywords:
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Multiple comparisons ; Clinical trials ; Type I error rate control
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Abstract:
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This talk introduces a general approach to constructing gate-keeping procedures for multiple testing problems arising in clinical trials with hierarchically ordered objectives (primary/secondary endpoints, dose-control comparisons, etc). The approach is applied to set up gate-keeping procedures based on popular multiple tests (Holm, fallback and Hochberg tests), resampling and parametric tests. The resulting procedures have a straightforward multi-stage structure that facilitates the implementation of gate-keeping procedures and communication of the results to non-statisticians. One can also account for logical restrictions among multiple analyses and improve the power of individual tests by eliminating comparisons that are no longer clinically meaningful. The general approach is illustrated using clinical trial examples.
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