临床研究护士现状调查与分析

Investigation and analysis of the current status of clinical research nurses

目的:调查并分析国内临床研究护士现状与需求,为构建研究护士培训体系、促进研究护士规范化培训以及实现研究护士规范化管理提供科学依据。方法:采用自制调查问卷对国内近70家知名临床试验机构的102名研究护士进行问卷调查,调查内容主要包括研究护士的一般资料、职业经历与工作内容、从事临床试验工作的成就感及培训需求。结果:参与问卷调查的102名研究护士中,学历为本科及以上者占92.15%,职称中级及以上者占53.92%。兼职研究护士占74.51%;在职业经历中,19.61%具有10年以上的临床试验经历;在临床试验分工中被授权参与过临床试验药品管理、样本管理和质量控制的比例分别为47.06%、40.20%和21.17%。能够在药物临床试验工作中获得较高成就感的研究护士占70.59%;在教育培训方面,研究护士认为临床试验相关法律法规、临床试验方案规范化实施与药物临床试验质量管理规范(good clinical practice,GCP)是最为重要的培训内容。结论:我国临床试验研究护士学历、护龄较高,但相对于飞速发展的创新药物和器械陆续注册上市与临床研究体系亟待完善的迫切需要,国内专业化的专职研究护士缺口较大,需要构建符合我国国情的研究护士培训、考核、评价体系,以提高研究护士专业化水平,助力提升我国的创新药物和器械临床试验研究的数量与质量。

AIM:To investigate and analyze the current situation and needs of clinical research nurses in China,in order to provide scientific basis for constructing a training system for research nurses,promoting standardized training,and achieving standardized management for them.METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China.The contents of the questionnaire mainly included the general information,professional experience and work content of the research nurses,the sense of accomplishment and training needs of clinical trial work.RESULTS:Among the 102 research nurses surveyed,92.15%have a bachelor's degree or above;53.92%of those have intermediate or higher professional titles;74.51%of them are part-time research nurse.Among professional experiences,19.61%have more than 10 years of clinical trial experience;47.06%,40.20%,and 21.17%of surveyed research nurses were authorized to participate in clinical trial drug management,sample management,and quality control;70.59%of research nurses have a high sense of achievement in their daily work.In terms of education and training needs,clinical trial related laws and regulations,standardized training for clinical trial protocol implementation,and good clinical practice(GCP)are the three most important aspects.CONCLUSION:Clinical research nurses in China have a relatively high level of education and nursing experience,but there is still a large gap in the amount of professional full-time clinical research nurses in China.Due to the rapid development of innovative drugs and devices,as well as the urgent need to improve the clinical research system,it is necessary to establish a training,assessment,and evaluation system for research nurses that is in line with China's national conditions in order to improve the professional level of research nurses,and improve the quantity and quality of clinical trial research on innovative drugs and devices in China.