Chapter 5
Multiplicity Adjustment Methods
Thomas Brechenmacher (QuintilesIMS)
Alex Dmitrienko (Mediana)
5.3 Procedures with a data-driven hypothesis ordering
5.4 Procedures with a prespecified hypothesis ordering
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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