基于风险的医疗器械临床试验伦理审查和质量管理  

Ethical Review and Quality Management of Medical Devices Clinical Trials based on Risk

作　　者：程毅[1] 李丽华 布格拉·米吉提 张翌韦 鲁瑞萍[1] 杨建华[1] CHENG Yi;LI Lihua;Buglar MIKITI;ZHANG Yiwei;LU Ruiping;YANG Jianhua(Drug Clinical Trial Institutions,the First Affiliated Hospital of Xinjiang Medical University,Urumqi 830011,China;Department of Pharmacy,Urumqi Maternal and Child Care Hospital,Urumqi 830011,China)

机构地区：[1]新疆医科大学第一附属医院药物临床试验机构,新疆乌鲁木齐830011 [2]乌鲁木齐市妇幼保健院药剂科,新疆乌鲁木齐830011

出　　处：《中国医学伦理学》2021年第3期314-318,327,共6页Chinese Medical Ethics

基　　金：国家科技重大新药创制专项“基于新疆区域特色的新药物临床评价技术平台的构建”(2020ZX09201030);乌鲁木齐市科学计划项目“新疆I期药物临床试验研究中心”(H171312002)。

摘　　要：随着我国创新药品器械研发能力的不断提高,开展医疗器械临床试验的项目数量也在不断增多。医疗器械临床试验是验证器械安全性的重要环节,其结果的可靠性直接关系到器械上市后的安全,而临床试验的质量是临床试验的关键。通过对医疗器械临床试验各环节的质量风险因素进行规划、识别与评估,并探讨了降低风险的应对措施,建立完善医疗器械风险管理质量体系,实现临床试验全过程质量管理。With the continuous improvement of the development capacity of innovative medical equipment in China,the number of projects to carry out clinical trials of medical devices is also increasing.Medical device clinical trial is an important link to verify the safety of the device,the reliability of the results is directly related to the safety of the device after marketing,and the quality of clinical trial is the key of clinical trials.Through planning,identifying and evaluating the quality risk factors in each link of the clinical trial of medical devices,this paper discussed the countermeasures to reduce the risk,to establish and improve the quality management system of the risk management of medical devices,and realize the quality management of the whole process of clinical trial.

关 键 词：临床试验 医疗器械 质量管理 伦理审查 

分 类 号：R-052[医药卫生]