ABSTRACT

Multiplicity issues are encountered in a variety of pharmaceutical applications with multiple objectives. In a pre-clinical setting, the objectives can correspond to multiple genetic markers. In clinical applications, the objectives can be defined in terms of multiple dose levels, endpoints or subgroup analyses. Most common sources of multiplicity in clinical trials are listed below:

• Multiple dose-control comparisons are commonly included in dosefinding studies to evaluate efficacy and safety properties of a treatment compared to a control.