医疗器械临床试验综合评价指标体系的构建  

Construction of Comprehensive Evaluation Index System for Clinical Trial of Medical Devices

作　　者：商朴 单彬 段丽娟 郭珉江[3] SHANG Pu;SHAN Bin;DUAN Lijuan;GUO Minjiang(Office of National Drug&Medical Device Clinical Trial Institution,Fuwai Hospital,Chinese Academy of Medical Sciences,Beijing 100037,China;Clinical Research Evaluation Center,Beijing Tigermed-Jyton Co.,LTD.,Beijing 102308,China;Department of Health and Medical Security Information Research,Institute of Medical Information,Chinese Academy of Medical Sciences,Beijing 100020,China)

机构地区：[1]中国医学科学院阜外医院国家药械临床试验机构办公室,北京100037 [2]泰格捷通(北京)医药科技有限公司临床研究评估中心,北京102308 [3]中国医学科学院医学信息研究所健康与医疗保障信息研究室,北京100020

出　　处：《中国医疗设备》2024年第9期119-124,143,共7页China Medical Devices

基　　金：中国医学科学院医学与健康科技创新工程(2021-I2M-1-045)。

摘　　要：目的构建科学、系统的医疗器械临床试验综合评价指标体系。方法在文献研究和专家调研的基础上,采用德尔菲法对医疗器械临床试验评价指标体系的各级指标进行重要性论证,采用层次分析法确定各级指标权重。结果构建的医疗器械临床试验评价指标体系包括研究能力与贡献、研究实施与管理及研究产出与评价3个维度,下设8项二级指标和22项三级指标,专家积极系数、权威系数和意见协调程度良好。结论本研究初步建立了医疗器械临床试验综合评价指标体系,具有较高的客观性和科学性,对医疗器械临床试验的综合评价和科学监管具有一定参考价值。Objective To construct a scientific and systematic evaluation index system for clinical trials of medical devices.Methods Based on literature research and expert survey,the importance of each level of indexes in the evaluation system was demonstrated using the Delphi method,and the weights of each level of indexes were determined using the analytic hierarchy process.Results The constructed clinical trial evaluation index system for medical devices included three dimensions:research ability and contribution,research implementation and management,and research output and evaluation.It consisted of 8 secondary indexes,and 22 tertiary indexes,with good expert enthusiasm,authority,and coordination of opinions.Conclusion This study has preliminarily established a comprehensive evaluation index system for clinical trials of medical devices,which has high objectivity and scientificity,and has certain reference value for the clinical trial comprehensive evaluation and scientific supervision of medical devices.

关 键 词：医疗器械 临床试验 评价指标 德尔菲法 层次分析法 

分 类 号：R197.3[医药卫生—卫生事业管理]