Analysis of clinical trials with multiple objectives
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*Alex Dmitrienko, Eli Lilly and Company 

Keywords: Multiple endpoints, Type I error rate, Gatekeeping procedures

The talk gives an overview of multiplicity adjustment methods used in clinical trials with multiple families of objectives, including trials with multiple primary and secondary endpoints, multiple dose-control comparisons and multiple subgroups. It summarizes recent research on multiple testing procedures for hypothesis testing problems with a hierarchical structure (termed gatekeeping procedures). Gatekeeping procedures have been widely used in clinical trials with multiple objectives due to the fact that they control the overall Type I error rate and enable trial sponsors to enrich product labels by including information on relevant secondary objectives. Popular methods for building gatekeeping procedures will be introduced and illustrated using clinical trials with multiple families of objectives.