Dmitrienko Tamhane 2009

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Dmitrienko, A., Tamhane, A.C. (2009). Gatekeeping procedures in clinical trials. Multiple Testing Problems in Pharmaceutical Statistics. Dmitrienko, A., Tamhane, A.C., Bretz, F. (editors). Chapman and Hall/CRC Press, New York.

This is Chapter 5 in Multiple Testing Problems in Pharmaceutical Statistics published in 2009 in the Chapman and Hall/CRC Biostatistics Series.


This chapter describes a class of procedures, called gatekeeping procedures, for testing hierarchically ordered hypotheses. Such hypotheses commonly arise in clinical trials when dealing with multiple endpoints, dose-control comparisons and subgroup analyses. The chapter reviews three main classes of gatekeeping procedures (serial, parallel and tree-structured gatekeeping procedures) that control the overall Type I error rate and efficiently account for the hierarchical structure of multiple objectives.

Further reading

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