基于研究者视角对重庆市临床试验管理现状的调查与分析  

Investigation and analysis on current status of clinical trial management from perspective of researchers in Chongqing

作　　者：李明红 谢江川 郭薇 谢林利 潘辛梅 曹丽亚 陈勇川 LI Ming-hong;XIE Jiang-chuan;GUO Wei;XIE Lin-li;PAN Xin-mei;CAO Li-ya;CHEN Yong-chuan(Department of Pharmacy,the First Affiliated Hospital of the Army Medical University,CHONGQING 400038,China)

机构地区：[1]陆军军医大学第一附属医院药学部,重庆400038

出　　处：《中国新药与临床杂志》2021年第7期507-510,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：重庆市科学技术委员会资助项目(cstc2018jsyj-zdcxX0079)。

摘　　要：目的基于研究者调查,分析重庆市医疗机构临床试验质量管理实施现状及存在问题。方法以重庆市22家医疗机构参与过临床试验的研究者为调研对象,采用自填式问卷调查相关问题。结果共发放问卷190份,回收有效问卷177份,有效回收率为93.2%。调查发现,有41名(23.2%)研究者近3年未做过临床试验。参与培训试验方案介绍172名(97.2%),培训不良事件/严重不良事件的收集与记录156名(88.1%),培训抢救预案132名(74.6%)。有113名(63.8%)研究者所在专业科室不进行临床试验项目的质控;有100名(56.5%)研究者所在的专业科室未配备专职研究护士。结论重庆市临床试验质量管理实施情况整体较好。但针对研究者的培训仍有待加强,且在专业科室对项目的质控及专职研究护士的配备等方面仍有欠缺。AIM To investigate and analyze the implementation status and existing problems of clinical trial quality management in medical institutions in Chongqing from the perspective of researchers. METHODS Taking the researchers who participated in clinical trials from 22 medical institutions in Chongqing as the research objects, self-filled questionnaires were used to investigate related questions. RESULTS A total of 190 questionnaires were sent out and 177 were effectively received. The effective recovery rate was 93.2%. The survey found that 41(23.2%) researchers had not conducted clinical trials in recent three years. A total of 172(97.2%) researchers were participated in the introduction of the training trial program, 156(88.1%) researchers were trained in the collection and recording of adverse events/serious adverse events, and 132(74.6%) researchers were trained in the rescue plan. There were 113(63.8%) researchers’ professional departments that did not conduct quality control of clinical trials. 100(56.5%) researchers’ professional departments were not equipped with full-time research nurses. CONCLUSION The implementation of clinical trial quality management in Chongqing is relatively good. However, the training of researchers still needs to be strengthened, and there are still some deficiencies in the quality control of the project in professional departments and the allocation of full-time research nurses.

关 键 词：研究人员 临床试验 全面质量管理 调查和问卷 

分 类 号：R969.4[医药卫生—药理学]