实施药物临床试验存在问题的调查分析与对策研究

发布时间：2018-03-30 12:49

本文选题：药物临床试验　切入点：研究者　出处：《中国新药杂志》2017年17期

【摘要】：目的:总结中山市人民医院机构研究者实施药物临床试验存在的问题并提出相应对策。方法:以中山市人民医院参加过药物临床试验的研究人员为调查对象,采用自填式问卷调查相关问题,调查数据用SPSS统计软件进行分析。结果:共调查122名研究人员,研究者参加临床试验积极性不高,研究过程中在知情同意书的签署、不良事件(AE)/严重不良事件(SAE)记录和处理、临床试验电子病程记录、试验药物管理、合并用药使用和记录等方面存在问题。结论:可采取临床试验配备专职临床研究协调员、开展多元化培训、提升研究者的临床研究思维、研究科室争取多开展高水平临床试验,提高研究者积极性等措施解决存在问题,从而规范药物临床试验操作规程和提高临床试验质量。
[Abstract]:Objective: to summarize the problems existing in the implementation of drug clinical trials by institutional researchers in Zhongshan people's Hospital and to put forward corresponding countermeasures. Methods: the researchers who participated in the clinical trials of drugs in Zhongshan people's Hospital were investigated. The investigation data were analyzed by SPSS software. Results: a total of 122 researchers were investigated, who were not active in clinical trials and signed informed consent in the course of the study. There are some problems in the recording and treatment of adverse events, electronic course record of clinical trials, drug management, combined use and recording of drugs, etc. Conclusion: clinical trials may be equipped with a full-time clinical research coordinator. To carry out diversified training, to enhance the researchers' clinical research thinking, to strive for more high-level clinical trials in the research departments, and to improve the enthusiasm of the researchers to solve the existing problems. In order to standardize the operation of clinical trials of drugs and improve the quality of clinical trials.
【作者单位】：中山市人民医院;
【基金】：中山市科技局项目(2015B1096)
【分类号】：R951

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