TL42: Composite Endpoints in Randomized Trials
*Cynthia M DeSouza, Vertex Pharmaceuticals  *Chenkun Wang, Vertex Pharmaceuticals 

Keywords: prioritized outcomes, joint rank test, pairwise comparisons, multiplicity

A composite endpoint is often used as a primary endpoint when treatment effects or frequency of individual components of the composite are likely to be small and combining them makes clinical sense for the disease under study. This can lead to better study power but can also lead to ambiguous findings and difficulty in interpreting study results. Share your experiences on the construction of a composite endpoint, strategies for analysis, and labeling lessons in a regulatory setting.