我院临床试验用药品管理中存在的问题及对策
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摘要
目的:提高药物临床试验管理水平,保证临床试验质量。方法:调取本院2017年5月—2018年4月在研项目的试验用药品管理检查结果,对查出的问题进行归纳及分析,查找原因,并就如何规范试验用药品的管理提出对策和建议。结果:查出不合格项23项,共计117个。通过对各环节问题的归纳分析,找到试验用药品管理不规范的原因主要集中在软硬件建设、药物管理人员、培训与沟通三个方面。提出建立中心药房、配备专职药物管理人员、加强培训与沟通的改善对策。结论:中心化管理有利于规范试验用药品的管理,从而提高试验用药品管理水平,保证药物临床试验过程真实规范、结果科学可靠。
Objective: To promote the management of drug clinical trials and to guarantee the quality of clinical trials. Methods:From May 2017 to April 2018,the investigational drug management inspection results of the research projects of our hospital were collected,and the problems identified were summarized,analyzed to find out the causes,and the countermeasures and suggestions on how to regulate the management of investigational drugs were put forward. Results: A total of 117 items were found in 23 cases.Through summarizing and analyzing the problems in each link,it was found that the causes for the non-standard management of investigational drugs were mainly attributed to the software and hardware construction,drug management personnel,training and communication. The improvement measures included establishing central pharmacy,arranging full-time staffs responsible for drug management,strengthening training and communication. Conclusions: Centralized management is beneficial to standardize the management of investigational drugs,so as to improve the management level of investigational drugs,and ensure that the clinical trials of drugs are truly standardized and the results are scientific and reliable.
Objective: To promote the management of drug clinical trials and to guarantee the quality of clinical trials. Methods:From May 2017 to April 2018,the investigational drug management inspection results of the research projects of our hospital were collected,and the problems identified were summarized,analyzed to find out the causes,and the countermeasures and suggestions on how to regulate the management of investigational drugs were put forward. Results: A total of 117 items were found in 23 cases.Through summarizing and analyzing the problems in each link,it was found that the causes for the non-standard management of investigational drugs were mainly attributed to the software and hardware construction,drug management personnel,training and communication. The improvement measures included establishing central pharmacy,arranging full-time staffs responsible for drug management,strengthening training and communication. Conclusions: Centralized management is beneficial to standardize the management of investigational drugs,so as to improve the management level of investigational drugs,and ensure that the clinical trials of drugs are truly standardized and the results are scientific and reliable.
引文
1唐铭婧,梅和坤,江学维,等.专职药师在临床管理中的重要作用[J].中国新药杂志,2017,26(22):2710-2713
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4 李树婷,杨丽,张黎,等.临床研究药物中心化管理现场评估标准[J].药物评价研究,2016,39(3):335-344
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6 Food and Drug Administration(FDA).Counterfeit drug task force report 2006 section V:what technical issues related to electronic track and trace need resolution.2006.Available at http://www.fda.gov/Drugs/Drug Safety/ucm172899
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8 单娇娇,汤依群,史美祺,等.临床药师干预对抗肿瘤药物临床试验方案偏离的影响[J].中国临床药理学与治疗学,2014,19(1):33-37
9 Julie Méthot,Diane Brisson,Daniel Gaudet.On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices(GCPs)[J].Clinical Trials,2012,9(2):265-271
10 王彦荣,李薇,戴欣雅,等.我院药物临床试验培训存在的问题与对策[J].中国药房,2015,26(1):18-20
11 安贺娟.《药物临床试验质量管理规范》培训在科室药物临床试验工作中的应用[J].解放军药学学报,2015,31(5):466-467
12 La H O,Chol S,Lee S K,et al.Current status and future directions for clinical trials pharmacy[J].Yakugaku Zasshi,2011,131(6):969-975
2 刘韬,王艺,邓丽婷,等.我院临床试用药品管理模式的构建[J].中国药房,2015,26(34):4766-4769
3 刘峰,邓贵新,李雪芹,等.试验药物管理中存在的问题及对策探讨[J].中国医药导报,2017,14(20):128-131
4 李树婷,杨丽,张黎,等.临床研究药物中心化管理现场评估标准[J].药物评价研究,2016,39(3):335-344
5 程晓华,刘丽忠,吕农华.浅谈我院药物临床试验机构运行管理模式的构建[J].中国新药与临床杂志,2013,32(5):362-365
6 Food and Drug Administration(FDA).Counterfeit drug task force report 2006 section V:what technical issues related to electronic track and trace need resolution.2006.Available at http://www.fda.gov/Drugs/Drug Safety/ucm172899
7 温雯,姜春梅,郎丽杰,等.基于药物临床试验项目管理系统的临床试验全程管理[J].中国医院管理,2015,35(5):55-57
8 单娇娇,汤依群,史美祺,等.临床药师干预对抗肿瘤药物临床试验方案偏离的影响[J].中国临床药理学与治疗学,2014,19(1):33-37
9 Julie Méthot,Diane Brisson,Daniel Gaudet.On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices(GCPs)[J].Clinical Trials,2012,9(2):265-271
10 王彦荣,李薇,戴欣雅,等.我院药物临床试验培训存在的问题与对策[J].中国药房,2015,26(1):18-20
11 安贺娟.《药物临床试验质量管理规范》培训在科室药物临床试验工作中的应用[J].解放军药学学报,2015,31(5):466-467
12 La H O,Chol S,Lee S K,et al.Current status and future directions for clinical trials pharmacy[J].Yakugaku Zasshi,2011,131(6):969-975