| 刘珊珊,张云娟,王健,董丹丹.山东省医疗器械临床试验机构体外诊断试剂临床试验现状与质量提升策略[J].中国药事,2022,36(9):1018-1025 |
| 山东省医疗器械临床试验机构体外诊断试剂临床试验现状与质量提升策略 |
| Current Status and Quality Improvement Strategy in in vitro Diagnostic Reagents Clinical Trials of Medical Device Clinical Trial Institutions in Shandong Province |
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| DOI：10.16153/j.1002-7777.2022.09.007 |
| 中文关键词: 体外诊断试剂 临床试验 医疗器械 质量管理 提升策略 |
| 英文关键词: in vitro diagnostic reagents clinical trials medical device quality control improvement measure |
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| 中文摘要: |
| 掌握目前山东省医疗器械临床试验机构体外诊断试剂临床试验的现状及存在的问题，探讨提升体外诊断试剂临床试验质量的策略。方法：通过查询国家药品监督管理局网站，结合对临床试验机构开展问卷调研和现场调研，对山东省医疗器械临床试验机构及相关专业备案情况、承接体外诊断试剂临床试验项目情况、临床试验团队构成、人员培训、临床试验管理等体外诊断试剂临床试验各方面情况进行统计分析。结果与结论：目前山东省医疗器械临床试验机构体外诊断试剂临床试验还存在着临床试验团队专职人员配备不到位、临床试验团队人员培训不足、临床试验质量管理制度不完善、研究者临床试验水平有待提高、相关监管法规体系不健全等问题，建议医疗器械临床试验机构制定科学完善的体外诊断试剂临床试验管理制度和标准操作规程，配备临床试验团队专职人员，加强人员的管理和培训，完善体外诊断试剂临床试验法规体系建设，探索创新监管模式，不断提升体外诊断试剂临床试验质量，促进体外诊断试剂行业高质量发展。 |
| 英文摘要: |
| Objective: To understand current status and existing problems in in vitro diagnostic reagents clinical trials of medical device clinical trial institutions in Shandong province, and explore the strategies for improving clinical trial quality of in vitro diagnostic reagents. Methods: Based on the data of clinical trial institutions on the official website of National Medical Products Administration, combined with the field study and questionnaire survey in the clinical trial institutions, statistical analysis was made on the registration of medical device clinical testing institutions and related majors in Shandong Province, the undertaking of clinical trials of in vitro diagnostic reagents, the composition of clinical trial teams, personnel training, clinical trial management and other aspects of clinical trials of in vitro diagnostic reagents. Results and Conclusion: There are a series of problems in the current clinical trials of in vitro diagnostic reagents in Shandong medical device clinical trial institutions, such as inadequate allocation of full-time staff in clinical trial team, the inadequate personnel training, the imperfection of quality management system of clinical trial, the need of improving the clinical trial level of the investigators, and the imperfect system of relevant regulatory regulations. Aiming at promoting the high-quality of the industry development of in vitro diagnostic reagents, it is suggested that the medical device clinical trial institutions should formulate a scientific and perfect management system of clinical trial of in vitro diagnostic reagent and standard operating procedures, allocate full-time personnel of the clinical trial team, strengthen personnel management and training, improve the construction of legal system of clinical trial of the in vitro diagnostic reagent, explore innovative supervision modes, and constantly improve the quality of clinical trials of the in vitro diagnostic reagent. |
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