| 王健,冯巧巧,刘珊珊.医疗器械临床试验风险管理思考与建议[J].中国药事,2024,38(3):292-297 |
| 医疗器械临床试验风险管理思考与建议 |
| Thoughts and Suggestions on Risk Management of Medical Device ClinicalTrials |
| 投稿时间：2023-02-04 |
| DOI：10.16153/j.1002-7777.2024.03.007 |
| 中文关键词: 医疗器械 临床试验 风险管理 质量管理 科学监管 |
| 英文关键词: medical device clinical trials risk management quality control scientifi c supervision |
| 基金项目: |
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| 中文摘要: |
| 目的：提高医疗器械临床试验各参与方的风险意识，提升质量管理水平，为构建医疗器械科学监管提供保障和技术支撑。方法：结合多年医疗器械临床试验监管经验和检查资料，分析医疗器械临床试验各个环节的风险因素，提出纠正预防措施。结果与结论：医疗器械临床试验各产品之间风险差异大，良好的方案设计较困难，对主要研究者的依赖性强，目前的监管模式单一。加强全方位的风险管理，将有效提升医疗器械临床试验质量管理水平，促进整个医疗器械行业的健康快速发展。 |
| 英文摘要: |
| Objective: To improve the risk awareness of all participants in clinical trials of medical devices,improve quality management level, to provide guarantee and technical supports for the construction of scientifi csupervision of medical devices. Methods: Combined with years of medical device clinical trial supervisionexperience and inspection data, the risk factors of all aspects of clinical trials of medical devices were analyzed,and corrective and preventive measures were proposed. Results and Conclusion: There were great diff erencesin risks among products in clinical trials of medical devices. It was diffi cult to design a good scheme, and thedependence on the main investigator was strong. The current regulatory model was single. Strengthening allroundrisk management will eff ectively improve the quality management level of medical device clinical trials andpromote the healthy and rapid development of the entire medical device industry. |
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