我院药物临床试验实施中方案偏离的回顾性研究

发布时间：2018-06-23 17:35

本文选题：药物临床试验 + 方案偏离　；参考：《中国药房》2017年25期

【摘要】：目的:研究药物临床试验实施中方案偏离的影响要素,为提高药物临床试验的质量提供参考。方法:对重庆医科大学附属第一医院2010-2016年开展的药物临床试验项目进行质量核查,对各年度方案偏离进行回顾性研究并归类分析,探讨方案偏离的类别、例数,并比较国际与国内试验项目以及是否有专职研究护士参与试验管理后方案偏离的差异,并提出改进措施。结果:我院2010-2016年开展药物临床试验27项涉及949例病案,方案偏离发生176例,占比18.55%;7年间方案偏离发生比例逐年降低。发生的方案偏离类别主要为观察/评价记录不全(30.11%)、检查漏项/"超窗"(28.41%)、不良事件及合并用药不当(14.20%)和药物管理存在疏漏(11.93%);有专职研究护士参与的项目方案偏离发生比例低于没有专职研究护士参与的项目(11.11%vs.28.67%,P0.01);国际多中心项目方案偏离发生比例低于国内项目(6.60%vs.28.84%,P0.01)。结论:建议应有针对性地加强药物临床试验中的薄弱环节,如临床试验机构应建立临床试验数据留存制度,电子数据及时异地备份等。此外,临床试验机构应尽量配备各专业专职研究护士,学习和借鉴国际多中心临床试验项目试验设计严谨科学、操作流程标准化及数据处理真实等做法,以切实减少方案偏离的发生,提高药物临床试验的质量。
[Abstract]:Objective: to study the influencing factors of program deviation in drug clinical trials, and to provide reference for improving the quality of drug clinical trials. Methods: the quality of the drug clinical trial project carried out in the first affiliated Hospital of Chongqing Medical University from 2010 to 2016 was verified. The deviation of each annual program was retrospectively studied and analyzed, and the categories and cases of the project deviation were discussed. The differences between international and domestic experimental projects and whether there are full-time research nurses involved in experimental management were compared and the improvement measures were put forward. Results: 27 clinical trials involving 949 medical cases were carried out in our hospital from 2010 to 2016, 176 cases of project deviation occurred, accounting for 18.55% of the seven years the proportion of project deviation decreased year by year. The main categories of programme deviations occurred were incomplete observation / evaluation records (30.11%), missing items / "window" (28.41%), adverse events and combined improper use of drugs (14.20%) and drug management omissions (11.93%), and those with full-time research nurses participated in the project deviation occurred. The proportion was lower than that of non-full-time research nurses (11.11vs.28.67P0.01), and the proportion of international multi-center project deviation was lower than that of domestic project (6.60vs.28.84P0.01). Conclusion: it is suggested that the weak links in clinical trials should be strengthened, such as the establishment of clinical trial data retention system and the timely backup of electronic data. In addition, clinical trial institutions should be equipped with professional full-time research nurses as far as possible, and learn from the practice of rigorous and scientific design of international multi-center clinical trial projects, standardization of operation procedures and authenticity of data processing, etc. In order to reduce the occurrence of program deviation, improve the quality of drug clinical trials.
【作者单位】：重庆医科大学附属第一医院呼吸科;四川大学华西口腔医院正畸科;
【基金】：重庆医科大学附属第一医院护理科研基金项目(No.HLJJ2014-08)
【分类号】：R95

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