We construct an asymptotic prediction interval for the population-wise error rate (PWER), which is a multiple type I error criterion for clinical trials with overlapping patient populations. The PWER is the probability that a randomly selected patient will receive an ineffective treatment. It must usually be estimated due to unknown population strata sizes, such that only an estimate can be controlled at the given significance level. We apply the delta method to find a prediction interval for the resulting true PWER, we demonstrate by simulations that the interval has the required coverage probability, and illustrate the approach with real data examples.

翻译：本文构建了群体错误率（PWER）的渐近预测区间，该指标是针对具有重叠患者群体的临床试验的多重第一类错误标准。PWER是指随机选择的患者接受无效治疗的概率。由于通常无法获知群体分层规模，该指标必须通过估计获得，因此只能在给定显著性水平下控制其估计值。我们应用Delta方法推导出真实PWER的预测区间，通过模拟验证该区间具有所需的覆盖概率，并采用实际数据案例对该方法进行说明。