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
Key words
medical device/clinical trial/evaluation indexes/Delphi method/analytic hierarchy process
维普
万方数据