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Dmitrienko Tamhane 2011

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Dmitrienko, A., Tamhane, A.C. (2011). Mixtures of multiple testing procedures for gatekeeping applications in clinical trials. Statistics in Medicine. 30, 1473-1488.

Abstract

This paper proposes a general framework for constructing gatekeeping procedures for clinical trials with hierarchical objectives. Such problems frequently exhibit complex structures including multiple families of hypotheses and logical restrictions. The proposed framework is based on combining multiple procedures across families. It enables construction of powerful and flexible gatekeeping procedures that account for general logical restrictions among the hypotheses of interest. A clinical trial in patients with schizophrenia is used to illustrate the approach for parallel gatekeeping while another clinical trial in patients with hypertension is used to illustrate the approach for gatekeeping with general logical restrictions.

Paper

Download Dmitrienko Tamhane 2011.

Software implementation

The algorithms for computing multiplicity-adjusted p-values for nonparametric and parametric mixture procedures in Example 1 (schizophrenia trial example) and Example 3 (hypertenstion trial example) are implemented in R. The programs can be downloaded from Implementation of Gatekeeping Procedures.

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.