加入ICH对我国药物临床试验机构工作的影响和思考
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篇名: 加入ICH对我国药物临床试验机构工作的影响和思考
TITLE:
摘要: 目的:概述国家食品药品监督管理总局(CFDA)加入人用药品注册技术要求国际协调会(ICH)后,我国药物临床试验机构建设面临的问题和应采取的对策,以及对我国临床研究管理工作的影响。方法:结合我院近些年来在执行药物临床试验质量管理规范(GCP)工作中的实践经验,并查阅ICH-GCP中的相关内容,从我国GCP(CFDA-GCP)和ICH-GCP的差异、加入ICH后药物临床试验机构面临的问题以及对我国临床研究工作的思考等方面进行论述。结果与结论:CFDA-GCP与ICH-GCP 在药物临床试验管理理念、伦理委员会的构架和功能、受试者权益保护、研究者和研究机构选择、试验药品管理要求以及临床试验资料管理等方面均存在差异。加入ICH后,现有的药物临床试验机构在组织管理架构、制度和标准作业程序、伦理委员会、GCP培训与继续教育、专业质控体系、试验用药品管理、资料管理及信息系统的建设与升级、临床研究协调员管理等方面均与ICH的要求存在差距。可以从修订相关的法规和指导原则、制订与ICH-GCP接轨的标准操作流程、建设规范化的伦理委员会、推行GCP培训与继续教育、完善质控体系和试验用药品管理、加强硬软件建设和临床研究协调员管理等方面入手,深入推进我国药物临床试验机构的规范化建设;同时实际工作中的诸如专职人员较少、制度落实不力等问题可以通过加强项目的管理、提高从业人员的素质以及构建常态化的跨区域合作等手段得以提高。
ABSTRACT: OBJECTIVE: To summarize the problems and countermeasures which the construction of drug clinical trial institutions face after China Food and Drug Administration (CFDA) join in ICH, and its effects on clinical study management in China. METHODS: Combined with the experience on Good Clinical Practice (GCP) in our hospital during recent years, reviewing related content of ICH-GCP, the differences between China’s GCP (CFDA-GCP) and ICH-GCP, the problems faced by drug clinical trial institutions after joining in ICH, and the thinking of China’s clinical research were discussed. RESULTS & CONCLUSIONS: There were differences between CFDA-GCP and ICH-GCP in the management concept of clinical drug trials, the structure and function of ethical committees, the protection of the rights and interests of subjects, the choice of researchers and research institutions, management requirements of experimental drugs and the management of documents and data. After joining in ICH, the current organization and management structure, system and standard operating procedures, ethics committee, GCP training and continuing education, professional quality control system, experimental drug management, data management and information system construction and upgrading, clinical research coordinator management and other aspects of the drug clinical trial institutions were far from the requirements of ICH. The standardization of drug clinical trial institutions in China can be further promoted by revising regulations and guidelines, formulating standard operating procedures in line with ICH-GCP, building standardized ethics committees, implementing GCP training and continuing education, improving quality control system and drug management in clinical trials, strengthening hardware and software construction and clinical coordinator management, etc. At the same time, problems such as fewer full-time personnel and weak implementation of the system can be improved by strengthening project management, improving the quality of employees and building normal cross-regional cooperation.
期刊: 2019年第30卷第11期
作者: 郭薇,谢林利,曹丽亚,陈勇川
AUTHORS: GUO Wei,XIE Linli,CAO Liya,CHEN Yongchuan
关键字: 药物临床试验机构;药物临床试验质量管理规范;人用药品注册技术要求国际协调会;中国;影响与对策
KEYWORDS: Drug clinical trial institution; Good Clinical Practice; ICH; China; Influence and countermeasure
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