全程质控视角下口腔医疗器械临床试验高质量管理对策  

Whole process quality based strategies for good clinical practice when using oral medical devices

作　　者：王琪[1] 梁新华[2] WANG Qi;LIANG Xinhua(State Institute of Drug/Medical Device Clinical Trials,National Clinical Research Center for Oral Diseases,Department of Prosthodontics,West China Hospital of Stomatology,Sichuan University,Chengdu 610041,China;State Institute of Drug/Medical Device Clinical Trials,National Clinical Research Center for Oral Diseases,Department of oral and maxillofacial surgery,West China Hospital of Stomatology,Sichuan University,Cheng du 610041,China)

机构地区：[1]国家药物/医疗器械临床试验机构,国家口腔疾病临床医学研究中心,四川大学华西口腔医学院口腔修复学系,四川成都610041 [2]国家药物/医疗器械临床试验机构,国家口腔疾病临床医学研究中心,四川大学华西口腔医学院口腔颌面外科学系,四川成都610041

出　　处：《口腔疾病防治》2020年第5期279-284,共6页Journal of Prevention and Treatment for Stomatological Diseases

基　　金：国家自然科学基金面上项目(81870779),四川省科技厅的重点研发项目(2019YFS0118)。

摘　　要：临床试验是验证新型口腔医疗器械有效性、安全性和可操作性的关键环节。随着我国口腔医疗器械研发能力提高,医疗器械临床试验数量逐渐增加,对质量管理提出了新的要求。本文在总结国内口腔医疗器械临床试验的特点基础上,通过识别临床试验质量关键管控点,探索全流程的高质量管控方法,研究提出基于全过程质控的口腔器械高质量管理模型,明确以全过程质量控制为中心,以临床试验设计为切入点,以全过程风险管控为关键点,建立质量管理协同、评价与后评价两大机制,同时加快高水平临床试验专业人才培养,提升口腔临床医生参与临床新型医疗器械研发的积极性,推动我国口腔医疗器械发展,为临床医生开展高质量的临床试验研究提供对策建议,引领新时代口腔专科特色的医疗器械临床试验的管理和规范。Clinical trials are the key step in verifying the effectiveness,safety and usability of novel oral medical devices.With improvements in invention capability,the number of clinical trials of medical devices has steadily increased domestically,indicating the need for new requirements for quality management.Here,on the basis of summarizing the characteristics of clinical trials for oral medical devices in China,we proposed a whole process quality control model for good clinical practice(WQGCP).This model clarified the management specifications for oral medical device clinical tri als in the new era.It indicates that the clinical trial design is the breakthrough point,while whole process risk control is the key point.This suggests the need for the establishment of a quality management cooperation system,evaluation and postevaluation systems and the training of high level personnel who conduct clinical trials.It also provides suggestions to promote the participation of oral clinicians in high quality research and invention of novel clinical medical devices with the aim of accelerating the development of oral medical devices in China.

关 键 词：口腔医疗器械 临床试验 质量控制 对策 全过程管理 风险管控 

分 类 号：R78[医药卫生—口腔医学]