摘要
目的:分析省域药品临床综合评价工作实施现状和存在问题,探索标准化路径和可复制推广模式,以期为各地开展综合评价工作提供经验参考。方法:通过现场调研、访谈、座谈及文献研究等方式,梳理出各省药品临床综合评价的实施进展、问题与挑战。结果:先试先行省份在组织体系、运行机制、信息平台和保障机制等方面取得阶段性进展,主要问题聚焦于评价目标理解、信息共享、政府主导、评价制度、质量控制等关键环节。结论:各省应把握评价工作回归临床价值的核心要义,建立健全沟通协同机制、主题遴选机制、专业机构与人员准入管理机制、质量控制机制、信息共享机制以及多元结果转化应用机制。
Objective To analyze the implementation status of comprehensive clinical evaluation of drugs at provincial level in China,and to explore the standardized path and reproducible promotion model, in order to provide experience reference for comprehensive evaluation in various regions. Methods Through document and literature study, expert discussion, expert forum and so on, the implementation progress, blocking points and challenges of the current comprehensive clinical evaluation policy in each province were studied and sorted out. Results The pilot provinces have made progress in organizational system construction, information construction, guarantee mechanism and specific work. The main problems focus on the understanding of evaluation objectives, information sharing, government leadership, evaluation system, quality control and other key links. Conclusions In order to promote the implementation of comprehensive clinical evaluation policy of drugs in China and guide the standardized and orderly development of evaluation work in each province, it is suggested that all provinces should grasp the core meaning of regression of evaluation work to clinical value. It is suggested to establish and improve the communication and coordination mechanism, a mechanism for selecting topics within the province, professional institutions and personnel access management mechanism, the provincial management and technical quality control mechanism. It is recommended to strengthen information platform construction, establish information sharing mechanism, explore the establishment of multiple results transformation and application mechanism, and accelerate the evaluation of the national chess mode.
作者
赵锐
石秀园
胡若飞
刘春平
ZHAO Rui;SHI Xiu-yuan;HU Ruo-fei;LIU Chun-ping(不详;National Health Development Research Center,Beijing 100044,China)
基金
国家卫生健康委委托项目“我国药品临床综合评价实施路径研究”。
关键词
药品临床综合评价
评价机制
关键环节
省域实践
comprehensive clinical evaluation of drugs
evaluation mechanism
key link
provincial practice
