医疗器械临床试验立项审查环节质量分析及防范策略

【摘 要】 立项审查是提高医疗器械临床试验质量的关键环节。通过对立项阶段发现的典型问题以案例的形式进行综合分析。提出，国家药监部门需进一步完善规章制度，申办者应承担临床试验质量管理责任，临床试验机构应建立完善的立项审查机制，研究者应提高规范意识，以保证试验质量和受试者权益。

【关键词】 医疗器械；临床试验；立项审查；环节质量

中图分类号：R197.39      文献标识码：A

Quality Analysis and Preventive Measures in the Project Approval Review Link of Medical Device Clinical Trials/ZHAO Tongxiang，MA Liping，PANG Hua，et al.//Chinese Health Quality Management，2024，31（2）：76-79

Abstract Project approval review is the key link to improve the quality of medical device clinical trials. Through a comprehensive analysis of typical problems found in the project initialization stage in the form of cases，it is suggested that the state drug regulatory authorities should further improve the regulations， that the applicants should assume the responsibility of clinical trial quality management， that the clinical trial institutions should establish a sound mechanism for project approval review， and that the researchers should enhance their normative awareness， so as to ensure the quality of the trial and the interests of the subjects.

Key words Medical Devices; Clinical Trials; Project Approval Review; Link Quality

First-author's address Peking University，Shougang Hospital，Beijing，100144，China

医疗器械临床试验是指在符合条件的医疗器械临床试验机构中，对拟申请注册的医疗器械（含体外诊断试剂）在正常使用条件下的安全性和有效性进行确认的过程［1］。（剩余7213字）