A general Bayesian approach to design adaptive clinical trials with time-to-event outcomes
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事件时间结局自适应临床试验设计的一般贝叶斯方法
- 研究问题
- 设计事件时间结局的自适应临床试验时，能否减少对完整数据生成过程的设定需求，尤其避免指定基准风险函数形式？
- 方法与思路
- 作者在一般贝叶斯框架中通过偏似然推断治疗效应，据此评估自适应设计，并以澳大利亚原住民婴儿疫苗试验重设计示范。
- 材料陈述的贡献
- 摘要称该设计评估方法对基准风险函数的具体形式具有稳健性，并通过第三剂疫苗保护效果试验的重设计展示其用途。
- 阅读关注点
- 应核对偏似然对应的模型条件、贝叶斯更新方式、允许的适应规则，以及模拟中功效和第一类错误的评估方法。
- 阅读边界
- 这是arXiv预印本，不能认定已经同行评审或接收。摘要未说明其余数据生成假设，不能将稳健性扩展为无需任何模型条件。
原文摘要
Clinical trials are an integral component of medical research. Trials require careful design to, for example, maintain the safety of participants, use resources efficiently and allow clinically meaningful conclusions to be drawn. Adaptive clinical trials (i.e. trials that can be altered based on evidence that has accrued) are often more efficient, informative and ethical than standard or non-adaptive trials because they require fewer participants, target more promising treatments, and can stop early with sufficient evidence of effectiveness or harm. The design of adaptive trials requires the pre-specification of adaptions that are permissible throughout the conduct of the trial. Proposed adaptive designs are then usually evaluated through simulation which provides indicative metrics of performance (e.g. statistical power and type-1 error) under different scenarios. Trial simulation requires assumptions about the data generating process to be specified but correctly specifying these in practice can be difficult, particularly for new and emerging diseases. To address this, we propose an approach to design adaptive clinical trials without needing to specify the complete data generating process. To facilitate this, we consider a general Bayesian framework where inference about the treatment effect on a time-to-event outcome can be performed via the partial likelihood. As a consequence, the proposed approach to evaluate trial designs is robust to the specific form of the baseline hazard function. The benefits of this approach are demonstrated through the redesign of a recent clinical trial to evaluate whether a third dose of a vaccine provides improved protection against gastroenteritis in Australian Indigenous infants.