The FORSS Framework for Sample Size and Power Calculations With Win Statistics for Hierarchical Endpoints
层级终点胜出统计量的样本量与功效计算:FORSS 框架
Win statistics have gained increasing popularity as primary analysis methods for clinical trials with hierarchical endpoints (HEs) as primary endpoints. However, existing sample size and power calculation approaches in trial design still face several limitations and challenges: simulation-based approaches are computationally intensive, while existing formula-based methods often rely on simplifying assumptions such as independence among HEs, or require specification of…