Chapter 5

Multiplicity Adjustment Methods

Thomas Brechenmacher (QuintilesIMS)

Alex Dmitrienko (Mediana)

5.1 Introduction

5.2 Single-step procedures

5.3 Procedures with a data-driven hypothesis ordering

5.4 Procedures with a prespecified hypothesis ordering

5.5 Parametric procedures

5.6 Gatekeeping procedures

5.7 References

5.8 Appendix

This chapter discusses statistical strategies for handling multiplicity issues arising in clinical trials with several clinical objectives. It defines commonly used multiplicity adjustments, including basic single-step testing methods, as well as more advanced stepwise methods relying on data-driven or pre-specified hypothesis ordering. The chapter also reviews gatekeeping testing strategies used in more advanced ...

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