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Interim Monitoring for Futility in Clinical Trials With Two Co-Primary Endpoints Using Prediction
Statistics in Biopharmaceutical Research ( IF 1.8 ) Pub Date : 2019-11-04 , DOI: 10.1080/19466315.2019.1677494
Koko Asakura 1, 2 , Scott R. Evans 3 , Toshimitsu Hamasaki 2, 3
Affiliation  

We discuss using prediction as a flexible and practical approach for monitoring futility in clinical trials with two co-primary endpoints (CPE). This approach is appealing in that it provides quantitative evaluation of potential effect sizes and associated precision, and can be combined with flexible error-spending strategies. We extend prediction of effect size estimates and the construction of predicted intervals to the two CPE case, and illustrate interim futility monitoring of treatment effects using prediction with an example. We also discuss alternative approaches based on the conditional and predictive powers, compare these methods and provide some guidance on the use of prediction for better decision in clinical trials with CPE.



中文翻译:

使用预测的两个共同主要终点的临床试验无效监测的中期监测

我们讨论了将预测作为一种灵活而实用的方法来监视具有两个共同主要终点(CPE)的临床试验中的无效性。这种方法之所以吸引人,是因为它提供了对潜在影响大小和相关精度的定量评估,并且可以与灵活的错误支出策略结合使用。我们将效果大小估计的预测和预测间隔的构造扩展到两个CPE案例,并使用一个示例说明了对治疗效果的临时无效监视。我们还讨论了基于条件和预测能力的替代方法,比较了这些方法,并提供了一些有关使用预测的指导,以便在CPE临床试验中更好地做出决策。

更新日期:2019-11-04
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