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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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。
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.
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.
引文
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[4]李睿,唐旭东,陆芳,等.药物临床试验机构制订标准操作规程的一些要点[J].中国临床药理学杂志,2013,29(8):633-634.
[5]周吉银,刘丹,曾圣雅,等.我国国家食品药品管理总局加入ICH-GCP对伦理委员会的要求[J].中国医学伦理学,2017,30(12):1512-1516.
[6]严康,沈爱玲.我国药物临床试验受试者保护问题研究[J].中国药房,2015,26(1):12-14.
[7]刘韬,王艺,邓丽婷,等.我院临床试验用药品管理模式的构建[J].中国药房,2015,26(34):4766-4769.
[8]栾鸾,陈玉文.药物临床试验机构备案制发生的变化和影响[J].药学与临床研究,2018,26(1):71-73.
[9]赵珊珊,刘阳,李静.三级医院药物临床试验机构建设管理实践[J].中国新药杂志,2018,27(11):1303-1308.
[10]张靖.加强我国药物临床试验机构建设的思考与对策[J].中国新药与临床杂志,2018,37(6):337-341.
[11]唐守艳,周铁,陆雯静,等.药物临床试验机构质量控制[J].解放军医院管理杂志,2017,24(11):1098-1100.
[12]张勋,宋苹,唐雪春.药物临床试验信息管理系统的设计与实现[J].现代医院,2013,9(5):148-149.
[13]吴伟,杨克旭,张颖超,等.对临床试验管理系统提高药物临床试验机构管理管理水平的研究[J].中国临床药理学杂志,2015,31(13):1318-1320.
[14]孙蔚雯,龚岚.药物临床试验机构管理体系构建中存在的问题与思考[J].临床医药文献杂志,2017,4(5):979-981.
[15]曹玉,李自普,王晨静,等.我国药物临床试验机构发展的现状与问题探讨[J].中国临床药理学杂志,2016,32(16):1512-1513.
[16]丁正磊,丛骆骆,吴彬.药物临床试验机构监管常见问题及对策研究[J].中国药事,2018,32(3):299-304.
[2]袁林,张皋彤,孙蔷.中国加入ICH始末及其重要意义[J].中国食品药品监管,2018(9):4-16.
[3]汪旻晖,卢建平,杨菁菁,等.中国与ICH药物临床试验质量管理规范的比较研究[J].中国新药杂志,2014,23(15):1786-1794.
[4]李睿,唐旭东,陆芳,等.药物临床试验机构制订标准操作规程的一些要点[J].中国临床药理学杂志,2013,29(8):633-634.
[5]周吉银,刘丹,曾圣雅,等.我国国家食品药品管理总局加入ICH-GCP对伦理委员会的要求[J].中国医学伦理学,2017,30(12):1512-1516.
[6]严康,沈爱玲.我国药物临床试验受试者保护问题研究[J].中国药房,2015,26(1):12-14.
[7]刘韬,王艺,邓丽婷,等.我院临床试验用药品管理模式的构建[J].中国药房,2015,26(34):4766-4769.
[8]栾鸾,陈玉文.药物临床试验机构备案制发生的变化和影响[J].药学与临床研究,2018,26(1):71-73.
[9]赵珊珊,刘阳,李静.三级医院药物临床试验机构建设管理实践[J].中国新药杂志,2018,27(11):1303-1308.
[10]张靖.加强我国药物临床试验机构建设的思考与对策[J].中国新药与临床杂志,2018,37(6):337-341.
[11]唐守艳,周铁,陆雯静,等.药物临床试验机构质量控制[J].解放军医院管理杂志,2017,24(11):1098-1100.
[12]张勋,宋苹,唐雪春.药物临床试验信息管理系统的设计与实现[J].现代医院,2013,9(5):148-149.
[13]吴伟,杨克旭,张颖超,等.对临床试验管理系统提高药物临床试验机构管理管理水平的研究[J].中国临床药理学杂志,2015,31(13):1318-1320.
[14]孙蔚雯,龚岚.药物临床试验机构管理体系构建中存在的问题与思考[J].临床医药文献杂志,2017,4(5):979-981.
[15]曹玉,李自普,王晨静,等.我国药物临床试验机构发展的现状与问题探讨[J].中国临床药理学杂志,2016,32(16):1512-1513.
[16]丁正磊,丛骆骆,吴彬.药物临床试验机构监管常见问题及对策研究[J].中国药事,2018,32(3):299-304.