A change point-based analysis procedure for improving the success rate of decision-making in clinical trials with delayed treatment effects.

ABSTRACT: A delayed treatment effect is a commonly observed phenomenon in tumor immunotherapy clinical trials. It can cause a loss of statistical power and complicate the interpretation of the analytical findings. This phenomenon also poses challenges for interim analysis in the context of phase II/III seamless design or group sequential design. It shows potential to lead researchers to make incorrect go/no-go decisions. Despite its significance, rare research has explored the impact of delayed treatment effects on the decision success rate of the interim analysis and the methods to compensate for this loss. In this study, we propose an analysis procedure based on change points for improving the decision success rate at the interim analysis in the presence of delayed treatment effects. This procedur

SUBMITTER: Xie LS 

PROVIDER: S-EPMC10520459 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature