影响我院药物临床试验质量的关键环节分析与干预

摘要

目的:发现影响我院药物临床试验质量关键环节,探讨提升药物临床试验质量的对策.方法:调取2014年我院药物临床试验机构10个专业14次药物临床试验研究质量检查结果,参照欧洲药品管理署检查发现问题的分级分类方法,对发生问题的关键环节进行分析,并评价对关键环节采取干预措施的效果.结果:2014年发现重要和一般问题总数共125例次,其中病例报告表填写、受试者知情同意、受试者入选和筛查、研究药物管理等4个环节发现质量问题数占全部问题数的79.20%,这些环节是影响药物临床试验质量的关键环节.通过采取加强研究者相关知识培训、完善制度和标准操作规程管理、加强环节质量控制、引入项目临床研究协调员、实行中心化药物管理等干预措施,2015年和2016年发现重要和一般问题总数分别为68、59例次,与2014年比较差异均有统计学意义(P0.05);2014-2016年均无严重问题发生.对于药物临床试验项目复杂程度较低的专业,通过采取干预措施后,2016年发现质量问题数明显下降,与2014年比较差异有统计学意义(P0.05).结论:通过管控药物临床试验过程中关键环节,可明显减少药物临床试验中一般问题的发生,但对重要问题的发生影响不大.不同专业承担药物临床试验项目复杂程度有区别,发生问题的环节和程度也有所不同,应在质量控制检查中加以区分.%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(P0.05). 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 (P0.05). 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.