论文标题
一个综合的工具箱,可促进药物开发中的定量决策科学:基于网络的R SHINY应用程序GoAhead
A Comprehensive Toolbox to Facilitate Quantitative Decision Science in Drug Development: A web-based R shiny application GOahead
论文作者
论文摘要
在药物开发的每个阶段,决策至关重要,并使知情和透明的GO/No-Go决策需要一个合理的定量决策框架。我们设计并实施了GoAhead,这是一种基于Web的综合工具,旨在改善统计学家和合作者如何实时计划和实施所选的GO/No-Go决策方法。在本文中,我们对基于双重标准和基于置信区间的方法进行了全面概述,以实现定量决策。还展示了贝叶斯和常见框架中的单臂设计和两个武器设计的说明性示例,还展示了具有MCP模型的多臂设计。可以在Shinyapps服务器上找到GoAhead。
Decision-making is critical at each stage of drug development and making informed and transparent Go/No-Go decisions require a sound quantitative decision framework. We designed and implemented GOahead, a comprehensive web-based tool to improve how statisticians and collaborators could prospectively plan and implement the selected Go/No-Go decision approach in real-time. In the paper, we conducted a comprehensive overview of dual-criterion and confidence interval-based approaches to enable quantitative decision-making. illustrative examples are demonstrated for single and two arms designs in both Bayesian and frequentist frameworks, multiple arms design with MCP-MOD is also demonstrated. GOahead can be found on shinyapps server.