影响我院药物临床试验质量的关键环节分析与干预

发布时间：2018-03-03 06:29

本文选题：药物临床试验　切入点：质量控制　出处：《中国药房》2017年22期 　论文类型：期刊论文

【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);2015年和2016年发现重要问题数分别为7、4例次,与2014年发现4例次重要问题数比较差异均无统计学意义(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);对于药物临床试验项目复杂程度较高的专业,2016年发现质量问题数没有明显下降,与2014年比较差异无统计学意义(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。
[Abstract]:Objective: to find out the key links affecting the quality of drug clinical trials in our hospital, and to explore the countermeasures to improve the quality of drug clinical trials. Methods: in 2014, the results of 14 drug clinical trials of 10 specialties in our hospital were obtained. According to the classification method of the European Drug Administration, the key links of the problems were analyzed and the effect of intervention on the key links was evaluated. Results: in 2014, the total number of important and general problems was 125. Among them, the case report form was filled out, the subjects were informed consent, the subjects were selected and screened, The study of drug management and other four links found that the number of quality problems accounted for 79.20% of the total number of problems. These links are the key links affecting the quality of drug clinical trials. Through strengthening the training of researchers' relevant knowledge, perfecting the management of the system and standard operating procedures, Strengthening link quality control, introducing project clinical research coordinator and implementing intervention measures such as centralized drug management, the total number of important and general problems found in 2015 and 2016 were 68 / 59, respectively. Compared with 2014, the difference was statistically significant (P 0.05), and the number of important problems found in 2015 and 2016 was 7 / 4, respectively. There was no significant difference in the number of major problems between 2014 and 2014. There were no serious problems in 2014-2016. After taking intervention measures, the number of quality problems was obviously decreased in 2016, compared with 2014, the difference was statistically significant (P 0.05). For the specialty with high complexity of drug clinical trial items, the number of quality problems did not decrease obviously in 2016. There was no significant difference between 2014 and 2014. Conclusion: by controlling the key links in the clinical trial of drugs, the occurrence of general problems in clinical trials of drugs can be significantly reduced. However, it has little influence on the occurrence of important problems. There are differences in the complexity of clinical trials of drugs in different specialties, and the links and degrees of problems are also different, which should be distinguished in quality control inspection.
【作者单位】：深圳市第二人民医院药物临床试验机构办公室;
【基金】：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)
【分类号】：R95

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