多准则决策分析在构建抗肿瘤药物获益-风险模型中的应用

The Application of Multi-Criteria Decision Analysis in Constructing a Benefit-Risk Model for Anti-Cancer Drug

本文主要讨论了国家监管机构在药品审批过程中如何进行获益-风险分析,并提出了多准则决策分析(MCDA)作为一种结构化、定量的方法来构建获益-风险模型。该方法可以量化药物获益-风险的相对平衡,并支持透明、一致和全面的药物获益-风险评估模型。同时,该方法还可以整合超出效益风险范畴的标准和高级统计分析,以支持实际决策制定。本文介绍了MCDA的优点,包括能够利用专家的判断和经验,透明地结合这些判断,以及通过敏感性分析来发现判断中的假设和不确定性。

The focus of the article is on how national regulatory agencies analyze the benefit-risk of drug approval process and propose a structured and quantitative method called Multi-Criteria Decision Analysis(MCDA)to construct benefit-risk models.This method allows for the quantification of the relative balance between the benefits and risks of drugs and supports transparent,consistent,and comprehensive assessment of benefit-risk models.Additionally,the method integrates criteria and advanced statistical analyses beyond the scope of benefit-risk to support practical decision-making.The article discusses the advantages of MCDA,including the ability to incorporate expert judgment and experience transparently,as well as identifying assumptions and uncertainties through sensitivity analysis.