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Kordzakhia Dmitrienko 2013

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Kordzakhia, G., Dmitrienko, A. (2013). Superchain procedures in clinical trials with multiple objectives. Statistics in Medicine, 32, 486-508.

Abstract

This paper introduces a new class of multiple testing procedures for addressing multiplicity problems arising in clinical trials with multiple objectives grouped into families. The families may correspond to equally important sets of objectives (co-primary endpoints) or ordered sets of objectives (primary and secondary endpoints). The procedures, termed superchain procedures, serve as an extension of several classes of other multiple testing procedures, including chain procedures and parallel gatekeep- ing procedures. Superchain procedures exhibit several desirable features, including flexible decision rules that can be tailored to a broad class of win criteria in confirmatory clinical trials. Additionally, superchain procedures enable the trial's sponsor to efficiently incorporate available distributional information in order to improve overall power. Finally, superchain procedures rely on straightforward testing algorithms, which facilitates their development. The new methodology is illustrated using clinical trial examples with two and three families of objectives.

Paper

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Review papers and chapters

For more information on gatekeeping procedures in clinical trials, see

Other papers

For information on other publications on gatekeeping procedures in clinical trials, see Gatekeeping Papers.