Conditional power in vaccine trials with seasonal variations

样本量测定 统计 临时的 I类和II类错误 计量经济学 中期分析 临床试验 统计能力 提前停车 复制 条件概率分布 计算机科学 医学 数学 内科学 地理 机器学习 人工神经网络 考古
作者
Xinyu Tang,Lihan Yan,John Scott
出处
期刊:Journal of Biopharmaceutical Statistics [Taylor & Francis]
卷期号:32 (3): 427-440
标识
DOI:10.1080/10543406.2022.2065504
摘要

Conditional power (CP) is widely used in clinical trial monitoring to quantify the evidence for futility stopping or sample size adaptation during the trial. When planning an interim analysis in vaccine trials for seasonal infectious diseases, CPs calculated under the hypothesized or currently estimated effect sizes may not truly reflect future data due to seasonal variations in disease incidence and/or vaccine efficacy (VE). Relying on these estimates alone could lead to erroneous decisions. Therefore, we carried out simulation studies to investigate the use of seven different choices for the drift parameter in computing CP or predictive power (PP) in end-of-season interim analysis. Our simulations showed that, when used to inform futility stopping, CP under the hypothesized effect and a weighted PP under a normal prior distribution appear to outperform others in terms of the overall type II error rate. All CPs and PPs considered in this study resulted in comparable powers and expected sample sizes when used to inform sample size adaptation. The performance of either CP or PP largely depends on the extent to which the chosen drift parameter or the prior distribution of the drift parameter matches the remainder of the trial. Weighted CP/PP tends to be less sensitive to settings where observed data and emerging data in future seasons differ substantially as they incorporate both current estimate and future variations. Therefore, weighted strategies deserve further exploration and perhaps increased usage in guiding trial operations because they are more robust to inaccuracies in prediction. In summary, for vaccine trials with seasonal variations, a decision on trial operations should be guided by a careful consideration of plausible CPs and PPs calculated under reasonable assumptions leveraging the data, prior hypotheses, and new evidence on clinical relevance.
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