Statistical Design and Planning of an Adaptive Trial using Hierarchical Composite Outcomes: A Practical example
采用分层复合结局的自适应试验设计与规划:实践示例
Hierarchical composite endpoints, such as those analyzed using the Finkelstein-Schoenfeld (FS) statistic, are increasingly used in clinical trials for their ability to incorporate clinically prioritized outcomes. However, adaptive design methods for these endpoints remain underdeveloped. This paper presents a practical framework for implementing sample size re-estimation (SSR) in trials using hierarchical composites, motivated by a cardiovascular trial with mortality,…