中国药房2017，Vol.28Issue(22)：3033-3036,4.DOI:10.6039/j.issn.1001-0408.2017.22.03
影响我院药物临床试验质量的关键环节分析与干预
Analysis and Intervention on the Key Links of the Quality of Drug Clinical Trials in Our Hospital
摘要
Abstract
OBJECTIVE:To discuss the countermeasure on the quality improvement of the drug clinical trials in our hospital based on the discovery of key links of the quality of clinical trials. METHODS:Quality results of 14 drug clinical trials in 10 ma-jors from the drug clinical trial institute in our hospital in 2014 were investigated. Referring to the grading and classifying methods of the inspection problems in European Medicines Agency,the key links of occurring problems were analyzed,and the effects of interventions for key links were evaluated. RESULTS:In 2014,totally 125 important and general problems were found,in which, the numbers of problems occurred in case report form filling,informed consent of subjects,enrolling and screening of subjects,in-vestigational products management accounted for 79.20%. The above 4 links were the key links affecting quality of drug clinical tri-als. According to strengthening the training about relevant knowledge of the researchers,improving system and standard operation procedures management,enhancing link quality control,introducing project clinical research coordinator,developing centralized drug management and other interventions,the total numbers of found important and general problems in 2015 and 2016 were 68 and 59,respectively. Compared with 2014,the differences were statistically significant(P<0.05). The numbers of found important problems in 2015 and 2016 were 7 and 4,respectively. Compared with 2014(4 important problems),the differences were not sta-tistically significant (P>0.05). There were no severe problems during 2014-2016. After interventions,numbers of occurring prob-lems in majors with less complex drug clinical trial had obviously declined in 2016. Compared with 2014,the differences were sta-tistically significant (P<0.05). While the major with relatively high complexity of drug clinical trial had no obvious decline in 2016. Compared with 2014,the differences were not statistically significant(P>0.05). CONCLUSIONS:Controlling the key links in drug clinical trial process can obviously reduce the occurrence of general problems while has little effect on the occurrence of im-portant problems. It is different for different majors in undertaking drug clinical trial projects,so as the links and degree of occur-ring problems. It should be distinguished in quality control checking.关键词
药物临床试验/质量控制/干预Key words
Drug clinical trial/Quality control/Intervention分类
医药卫生引用本文复制引用
吴建龙,陈斌,佘定平,黄晓晗..影响我院药物临床试验质量的关键环节分析与干预[J].中国药房,2017,28(22):3033-3036,4.基金项目
深圳市战略性新兴产业发展专项资金2013年第五批扶持计划(No.生物产业类第17号) （No.生物产业类第17号）
