管理视角下临床研究质量评价指标体系的系统综述  

A Systematic Review of Indication Systems for Assessing Clinical Research Quality from Managerial Perspective

作　　者：陈夏燕 李倩倩[1,2] 孟佳雪[1] 苑杰 李会娟[1] CHEN Xiayan(Clinical Research Institute,Institute of Advanced Clinical Medicine,Peking University,Beijing,100191,China)

机构地区：[1]北京大学临床医学高等研究院,临床研究所,北京100191 [2]北京大学第一医院,北京100034

出　　处：《医学与社会》2025年第3期17-24,38,共9页Medicine and Society

基　　金：首都卫生发展科研专项,编号为2022-2G-4253。

摘　　要：目的:系统梳理2012-2024年临床研究质量评价指标体系,为我国临床研究管理实践提供参考。方法:检索Pubmed、Embase、中国知网、万方数据知识服务平台、中国生物医学文献学术分析系统中临床研究质量评价文献。经筛选后,提取作者、发表时间、国家、研究角度、申办方类型、研究设计、产品类型、研究阶段、指标构建方法、指标体系结构、一级指标、指标评价和应用等信息。结果:共检索8758篇文献,纳入20篇,包括18个指标体系。指标体系从监管部门、医疗卫生机构和研究者等角度出发,覆盖了药物、器械、疫苗、干细胞研究等产品类型,涉及从立项、实施到结束各阶段。其中,9个可进行定量评分,5个进行了信效度评价,8个进行了应用,指标体系共同突显了对受试者保护、方案依从性和数据准确性的普遍重视。结论:当前指标体系对临床研究质量管理具有重要的引导、评价和预警作用,但在方法的客观性、信效度评价和指标应用方面仍需完善,未来的指标体系应关注以患者为中心的设计、多中心研究、智能化技术应用等方面。Objective:This study systematically summarized clinical research quality assessment indication systems from 2012 to 2024,so as to provide insights for clinical research management practices in China.Methods:A search was conducted in databases such as PubMed,Embase,CNKI,Wanfang and SinoMed,focusing on literature related to quality assessment of clinical research.Data were extracted on authors,publication dates,countries,research perspectives,sponsor type,study design,product type,stages,methodologies,indication systems structure,primary quality assessment indicators,evaluations and application of indicators.Results:This study reviewed a total of 8758 papers,of which twenty articles encompassing eighteen indication systems were included.These systems,originating from regulatory,institutional,and researcher perspectives,covered various types of clinical research,including drugs,devices,vaccines,and stem cell studies,and involved all stages from initiation to completion.Nine of the indication systems offered quantitative scoring,five systems underwent validation for reliability and validity,and eight were practically applied.Common emphases among these systems included the protection of participants,protocol compliance,and data accuracy.Conclusion:While the current indication systems provide significant guide,assess,and early warnings for clinical research,further improvement is needed in their objectivity,reliability,validity and application.Future indication systems should focus on patient-centered design,multi-center studies,and the application of intelligent technologies.

关 键 词：临床研究 临床试验 质量评价 指标体系 系统综述 

分 类 号：R-05[医药卫生] R197.3