构建我国药品临床综合评价工作机制的思考
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篇名: 构建我国药品临床综合评价工作机制的思考
TITLE: Reflections on the Establishment of Clinical Comprehensive Evaluation Mechanism for Drugs in China
摘要: 目的:推进我国药品临床综合评价工作的具体落实,促进药品回归临床价值,提高有限资源的利用效率,为卫生健康部门的决策者提供参考依据。方法:通过梳理药品临床综合评价相关政策文件和文献,介绍国内相关政策演进及研究进展,分析并归纳加拿大、美国、英国、澳大利亚、欧洲、国际药物经济学和结果研究学会等国家(地区/组织)的先进经验(包括评估主体、评估价值维度、评估方法、评估流程与结果应用),提出构建我国药品临床综合评价工作机制的相关建议。结果与结论:建议通过以下措施来构建我国药品临床综合评价机制,包括以决策需求为导向,进一步明确药品临床综合评价的发展目标和定位;发挥政府主导作用,加强部门间合作和政策的协同;建立内外部标准可溯质控体系,坚持公开、公正、公平的原则;充分发挥信息化和大数据作用,加强对评价方法学和评价标准的探索;加强评价结果的转化应用,推动评价结果服务政策决策等。
ABSTRACT: OBJECTIVE:To prom ote the implementation of clinical comprehensive evaluation of drugs in China ,promote the return of drugs to clinical value ,improve the utilization efficiency of limited resources ,and provide reference for decision makers of health departments. METHODS :By combing the relevant policy documents and literatures of clinical comprehensive evaluation of drugs,the evolution and research progress of relevant policies in China were introduced ;the advanced experiences (including evaluation subjects ,evaluation value dimensions ,evaluation methods ,evaluation procedures and results applications )of Canada ,the United States ,the United Kingdom ,Australia,Europe,International Society for Pharmacoeconomics and Outcomes Research and other countries (regions/organizations)were analyzed and summarized ;relevant suggestions on the construction of China ’s clinical comprehensive evaluation mechanism for drugs were put forward. RESULTS & CONCLUSIONS :It is suggested that the following measures should be taken to construct the clinical comprehensive evaluation mechanism of drugs in China including that the development goal and orientation of clinical comprehensive evaluation of drugs should be further clarified with the guidance of decision-making needs ;the government should play a leading role and strengthen inter departmental cooperation and policy coordination;the traceability quality control system of internal and external standards should be established ,adhere to openness , fairness and fair ;at the same time ,it is suggested to give full play to the role of informatization and big data ,strengthen the exploration of evaluation methodology and standards ,strengthen the transformation and application of evaluation results ,and promote the service of evaluation results to policy decision-making.
期刊: 2020年第31卷第23期
作者: 石秀园,赵锐,李璠,刘春平,高晶磊,赵琨
AUTHORS: SHI Xiuyuan ,ZHAO Rui,LI Fan,LIU Chunping ,GAO Jinglei ,ZHAO Kun
关键字: 药品临床综合评价;多准则决策分析;评价机制
KEYWORDS: Clinical comprehensive evaluation of drugs ;Multi-criteria decision analysis ;Evaluation mechanism
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