我国16家儿科临床试验机构试验药物管理现状调查研究  

Investigation and research on the current situation of experimental drug management in 16 pediatric clinical trial institution in China

作　　者：吴文文[1] 丁倩 许静[1] 王晓玲 WU Wen-wen;DING Qian;XU Jing;WANG Xiao-ling(Department of Pharmacy,Children's Hospital of Nanjing Medical University,Nanjing 210008,China;Clinical Research Center,Bejing Children's Hospital Afiliated to Capital Medical University/National Center for Children's Health,Beijing 100045,China)

机构地区：[1]南京医科大学附属儿童医院药学部,南京210008 [2]国家儿童医学中心,首都医科大学附属北京儿童医院临床研究中心,北京100045

出　　处：《中国新药杂志》2021年第3期220-225,共6页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2017ZX09304029);2020年度“南京药学会——常州四药医院药学科研基金”资助项目(2020YX024)。

摘　　要：目的:本研究旨在调查我国儿童(儿童妇女)专科临床试验机构试验药物管理现状,为设完善儿科临床试验药物管理体系提供依据。方法:使用问卷调查法,对中国儿科人群药物临床试验协作网内16家儿科临床试验机构进行调研,对调查数据进行统计和分析并提出建议。结果:共发放问卷16份,问卷回收率和有效率均为100%。各机构试验药物管理基本情况良好,但仍然具有一定的改进空间。结论:调查结果较好地反映了当前我国儿童专科临床试验机构试验药物管理现状。目前试验药物管理发展的重点应当在于进一步完善药物管理模式、加大软硬件建投入力度、优化专业人员配备、完善绩效分配制度和人员激励机制、加强试验药物预算评估管理等方面。Objective: The purpose of this study is to investigate the status of experimental drug management in pediatric clinical trial institutions in China,provide a basis for administrative departments and institutions to formulate standardized management policies for pediatric clinical trial drugs,as well as establish and improve a pediatric clinical trial drug management system. Methods: Questionnaire survey was conducted in 16 pediatric clinical trial institutions registered in Chinese Pediatric Population Clinical Trial Collaboration Network. Statistics and analysis were conducted on the survey data to make recommendations. Results: A total of 16 questionnaires were distributed,and 16 valid questionnaires were recovered. The questionnaire recovery rate was 100% and 16 questionnaires were recovered with an efficiency of 100%. The basic situation of trial drug management in various institutions is satisfactory,but there is still improvement room for the management model,software and hardware investment,staffing,incentive mechanism,as well as budget management. Conclusion: The investigation results well reflect the current situation of drug administration in pediatric clinical trial institutions in China. At present,the development of experimental drug management should focus on perfecting the drug management mode,increasing the investment in hardware and software,optimizing the professional staffing,improving the performance distribution system and personnel incentive mechanism,and strengthening the management of experimental drug budget evaluation.

关 键 词：药物临床试验 试验药物管理 儿童专科临床试验机构 儿童药物 问卷调研 

分 类 号：R969.4[医药卫生—药理学]