Designing trials with multiple objectives with graphical approach for multiple scenarios

A Adam Ding; Yulin Li; Samuel S Wu

doi:10.1016/j.conctc.2025.101569

Designing trials with multiple objectives with graphical approach for multiple scenarios

Contemp Clin Trials Commun. 2025 Nov 10:48:101569. doi: 10.1016/j.conctc.2025.101569. eCollection 2025 Dec.

Authors

A Adam Ding¹, Yulin Li², Samuel S Wu³

Affiliations

¹ Department of Mathematics, Northeastern University, Boston, MA, USA.
² Department of Biostatistics, University of Florida, Gainesville, FL, USA.
³ Health Informatics Institute, University of Southern Florida, Tampa, FL, USA.

Abstract

Clinical trials with multiple objectives require careful control of the overall error rate through adjustments for multiple hypothesis testing. Design optimization must account for these adjustments across various plausible scenarios. This paper introduces a framework for optimizing trial designs in multiple scenarios using graphical approaches. The method is demonstrated in a pain study trial, highlighting improvements in overall performance across multiple scenarios.

Keywords: Bonferroni procedure; Graphical approach; Multiple testing; Power optimization.