On sample size determination for restricted mean survival time-based tests in randomized clinical trials
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随机临床试验中基于限制平均生存时间检验的样本量确定
- 研究问题
- 随机试验采用基线协变量增强的限制平均生存时间检验时，如何在治疗组生存曲线难以预先指定的情况下规划样本量与功效？
- 方法与思路
- 作者提出增强型检验的近似样本量公式，无须指定治疗组完整生存曲线，并利用盲态数据更新基线协变量与鞅残差的相关性。
- 材料陈述的贡献
- 摘要称，该方案补充了协变量增强型检验的样本量设计方法，并旨在生存曲线无法正确预设时实现给定生存时间差的目标功效。
- 阅读关注点
- 应核对近似公式仍需哪些生存与删失信息、相关性如何通过盲态数据估计，以及样本量重估对检验水平和实际功效的影响。
- 阅读边界
- 依据的是 arXiv 预印本摘要，同行评审及期刊接收未核实；摘要未说明近似成立条件，不能认定任意生存曲线下均能达到目标功效。
原文摘要
Restricted mean survival time (RMST) is gaining attention as a measure to quantify the treatment effect on survival outcomes in randomized clinical trials. Several methods to determine sample size based on the RMST-based tests have been proposed. However, to the best of our knowledge, there is no discussion about the power and sample size regarding the augmented version of RMST-based tests, which utilize baseline covariates for a gain in estimation efficiency and in power for testing the no treatment effect. The conventional event-driven study design based on the log-rank test allows us to calculate the power for a given hazard ratio without specifying the survival functions. In contrast, the existing sample size determination methods for the RMST-based tests relies on the adequacy of the assumptions of the entire survival curves of two groups. Furthermore, to handle the augmented test, the correlation between the baseline covariates and the martingale residuals must be handled. To address these issues, we propose an approximated sample size formula for the augmented version of the RMST-based test, which does not require specifying the entire survival curve in the treatment group, and also a sample size recalculation approach to update the correlations between the baseline covariates and the martingale residuals with the blinded data. The proposed procedure will enable the studies to have the target power for a given RMST difference even when correct survival functions cannot be specified at the design stage.