药物开发中定量决策方法的认识和使用
Awareness and use of quantitative decision-making methods in pharmaceutical development
摘要：
在过去的几年里，制药行业经历了药物开发成本的增加和持续的高损耗率。从统计角度应对这一挑战的一项建议是，使用定量决策方法，支持对构成不同发展水平决策基础的证据进行数据驱动的客观评估。行业内统计领导者的认识不断提高，导致欧洲EFSPI/PSI定量决策特别兴趣小组（ESIG）的成立，以分享经验，收集最佳实践，并促进QDM的使用。在本文中，我们介绍了QDM的关键组成部分，并提出了QDM方法在试验，程序和投资组合水平的例子。ESIG创建了一份调查问卷，以了解QDM方法目前在不同开发阶段中的使用方式和程度。我们提出了主要的问卷调查结果，我们显示QDM已经使用今天，但也可以确定未来的改进领域。特别是，统计人员应提高其在跨职能决策中的能见度、参与度和领导力。
英文摘要：
The pharmaceutical industry has experienced increasing costs and sustained high attrition rates in drug development over the last years. One proposal that addresses this challenge from a statistical perspective is the use of quantitative decision-making (QDM) methods to support a data-driven, objective appraisal of the evidence that forms the basis of decisions at different development levels. Growing awareness among statistical leaders in the industry has led to the creation of the European EFSPI/PSI special interest group (ESIG) on quantitative decision making to share experiences, collect best practices, and promote the use of QDM. In this paper, we introduce key components of QDM and present examples of QDM methods on trial, program, and portfolio level. The ESIG created a questionnaire to learn how and to what extent QDM methods are currently used in the different development phases. We present the main questionnaire findings, and we show where QDM is already used today but also where areas for future improvement can be identified. In particular, statisticians should increase their visibility, involvement, and leadership in cross-functional decision-making.
机构、总结、中文摘要均由AI分析而来，可能存在错误，请以论文正文为准。
