||Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes.
Hamasaki, Toshimitsu ,
Asakura, Koko ,
Evans, Scott R ,
Sugimoto, TomoyukiSozu, Takashi
Statistics in biopharmaceutical research
54 , 2015-03-18 , Taylor & Francis Group
We discuss the decision-making frameworks for clinical trials with multiple co-primary endpoints in a group-sequential setting. The decision-making frameworks can account for flexibilities such as a varying number of analyses, equally or unequally spaced increments of information and fixed or adaptive Type I error allocation among endpoints. The frameworks can provide efficiency, i.e., potentially fewer trial participants, than the fixed sample size designs. We investigate the operating characteristics of the decision-making frameworks and provide guidance on constructing efficient group-sequential strategies in clinical trials with multiple co-primary endpoints.