{"title":"A hybrid Bayesian-frequentist predictive design for monitoring multi-stage clinical trials","authors":"Z. Djeridi, H. Merabet","doi":"10.1080/07474946.2019.1648919","DOIUrl":null,"url":null,"abstract":"Abstract In this article, we propose a hybrid-Bayesian frequentist approach using a Bayesian sequential prediction of the index of satisfaction. For interim analysis that addresses prediction hypothesis, such as futility monitoring with delayed outcomes, the prediction of satisfaction properly accounts for the amount of data remaining to be observed in a clinical trial and has the flexibility to incorporate additional information via auxiliary variables. The prediction of satisfaction design guarantees the type I error rate and does not require intensive computation or comprehensive simulation. The design is retrospectively applied to a lung cancer clinical trial.","PeriodicalId":48879,"journal":{"name":"Sequential Analysis-Design Methods and Applications","volume":"38 1","pages":"301 - 317"},"PeriodicalIF":0.6000,"publicationDate":"2019-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/07474946.2019.1648919","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Sequential Analysis-Design Methods and Applications","FirstCategoryId":"100","ListUrlMain":"https://doi.org/10.1080/07474946.2019.1648919","RegionNum":4,"RegionCategory":"数学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"STATISTICS & PROBABILITY","Score":null,"Total":0}
引用次数: 1
Abstract
Abstract In this article, we propose a hybrid-Bayesian frequentist approach using a Bayesian sequential prediction of the index of satisfaction. For interim analysis that addresses prediction hypothesis, such as futility monitoring with delayed outcomes, the prediction of satisfaction properly accounts for the amount of data remaining to be observed in a clinical trial and has the flexibility to incorporate additional information via auxiliary variables. The prediction of satisfaction design guarantees the type I error rate and does not require intensive computation or comprehensive simulation. The design is retrospectively applied to a lung cancer clinical trial.
期刊介绍:
The purpose of Sequential Analysis is to contribute to theoretical and applied aspects of sequential methodologies in all areas of statistical science. Published papers highlight the development of new and important sequential approaches.
Interdisciplinary articles that emphasize the methodology of practical value to applied researchers and statistical consultants are highly encouraged. Papers that cover contemporary areas of applications including animal abundance, bioequivalence, communication science, computer simulations, data mining, directional data, disease mapping, environmental sampling, genome, imaging, microarrays, networking, parallel processing, pest management, sonar detection, spatial statistics, tracking, and engineering are deemed especially important. Of particular value are expository review articles that critically synthesize broad-based statistical issues. Papers on case-studies are also considered. All papers are refereed.