口腔医疗器械临床试验方案设计要点的把控  

Control of key points in designing protocol of clinical trials for dental medical devices

作　　者：邱楠 彭寒松 尚姝环 Qiu Nan;Peng Hansong;Shang Shuhuan(State Institute of Medical Devices Clinical Trial,School of Stomatology,Wuhan University,Wuhan 430071)

机构地区：[1]武汉大学口腔医院国家医疗器械临床试验机构办公室,武汉430079

出　　处：《口腔材料器械杂志》2024年第2期120-123,共4页Chinese Journal of Dental Materials and Devices

基　　金：国家自然科学基金青年基金项目(编号:81101162)。

摘　　要：基于口腔医学专业和口腔医疗器械的特点,探讨如何在口腔医疗器械临床试验方案的设计过程中把控纳排标准制定、对照设置、疗效评估、盲法设计、样本量计算等关键点。从口腔医疗器械临床试验起始阶段开始,理清思路,把控设计的要点,提升设计与实施的连贯性,以期防患于未然,提高临床试验质量。Based on the characteristics of stomatology and dental medical devices,the key points of clinical trial design for dental medical devices were discussed,such as establishing inclusion/exclusion criteria,control setting,treatment efficacy assessment,blinding design,sample size calculation.From the initial stage of clinical trials of dental medical devices,the key points of clinical trial design should be controlled by clarifying the clinical trial ideas to keep the consistency of design and implementation,so as to prevent the occurrence of problems and improve the quality of clinical trials.

关 键 词：临床试验 医疗器械 方案设计 口腔医学 

分 类 号：TH787[机械工程—仪器科学与技术]