国内外抗肿瘤药物临床价值评估体系比较
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篇名: 国内外抗肿瘤药物临床价值评估体系比较
TITLE: Comparison of evaluation system for clinical value of antineoplastic agents at home and abroad
摘要: 目的 介绍国内外主要的抗肿瘤药物临床价值评估体系,为我国以临床价值为导向的抗肿瘤药物研发指导原则的不断完善提供参考。方法查阅国外抗肿瘤药物价值评估体系的相关资料和国内抗肿瘤药物研发和管理政策,对其维度、视角、目标受众、应用范围、优缺点等进行梳理与对比分析,提出完善我国抗肿瘤药物临床价值评估体系的建议。结果与结论7个国外价值评估体系(美国临床肿瘤学会价值框架、欧洲临床肿瘤学学会临床效益量表、美国临床和经济评估研究所价值评估框架等)各有特点,在不同的设定下有其独特的优势;几种价值评估体系因侧重的研究视角和受众群体不同,评判价值的标准存在一定程度的差异。而价值维度在不断地顺应科学价值和社会需求动态变化,不仅包括安全性、有效性和经济性,还包括创新性、公平性、生命质量等多个高价值属性;部分评估体系在展现形式以及评估模式上采用了比较方便且顺应信息时代趋势的价值评估工具,促进了医患共享决策。我国可以综合国外价值评估体系的特点并结合我国抗肿瘤药物研发和应用现状,对药品的有效性、安全性、生命质量、研发成本以及定价进行综合考虑,使其定位合理,真正从药品研发、临床应用以及药品可及性和公平性等角度解决患者需求。
ABSTRACT: OBJECTI VE To introduce the evaluation system for clinical value of antineoplastic agents at home and abroad ,and to provide reference for continuous improvement of clinical value-oriented antineoplastic agents development and research guideline in China. METHODS The suggestions were put forward to improve the evaluation system for clinical value of antineoplastic agents in China by consulting the relevant data of evaluation system for clinical value of antineoplastic agents at home and abroad and domestic antineoplastic agents R&D and management policies ,sort outing and analyzing comparatively their dimensions , perspectives,target audiences ,application scope ,advantages and disadvantages. RESULTS & CONCLUSIONS Seven foreign value evaluation systems (value assessment framework of American Society of Clinical Oncology ,clinical benefit scale of European Society of Clinical Oncology ,value evaluation framework of American Institute of Clinical and Economic Evaluation , etc.)had their own characteristics and unique advantages under different settings ;several value evaluation systems differed in the criteria for defining value ,depending on the perspective and population they focus on. The value dimensions were constantly changing dynamically in response to scientific values and social needs ,including not only safety ,efficacy and cost-effectiveness , but also innovation ,fairness,quality of life attributes. Some evaluation systems adopted value assessment tools that followed the trend of the information age in the presentation form and assessment mode ,which promoted shared decision-making between doctors and patients. Combining the characteristics of foreign value evaluation system and the current situation of development and application of antineoplastic agents in China ,we can have a deeper understanding of drug efficacy ,safety,quality of life ,research and development cost and pricing in the future. Antineoplastic 2021-10-28) agents will have a more reasonable position to solve the unmet needs of patients from the perspectives of drug research and development, clinical application , drug accessibility and fairness.
期刊: 2022年第33卷第11期
作者: 郎驿天,柴青青,廖雅慧,刘晓琰,胡元佳
AUTHORS: LANG Yitian,CHAI Qingqing ,LIAO Yahui,LIU Xiaoyan ,HU Yuanjia
关键字: 抗肿瘤药物;临床价值;价值评估体系
KEYWORDS: antineoplastic agents ;clinical value ;value
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