作　　者： (刘峰）; (邓贵新）; (李雪芹）; (王桂凤）;

机构地区： 中山市人民医院,中山528403

出　　处： 《中国新药杂志》 2017年第17期2059-2063,共5页

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。 Objective： To summarize our institutional investigators problems existied in the implementation of drug clinical trials and put forward corresponding countermeasures. Methods： Questionnaire of self-administered questionnaires was used to investigate the subjects who participated in the clinical trial of Zhongshan People＇s Hospital. The survey data were analyzed with SPSS statistical software. Results： A total of 122 investigators were enrolled in the study,there are many problems existed in the study,such as investigators＇ enthusiasm is not high to participate in clinical trials,the signing of informed consent form,AE/SAE recording and processing,clinical trial electronic history record,research drug management,combined medication and the record,etc. Conclusion：clinical trials can be carried out by a full-time clinical research coordinator,diversified training to enhance the investigators＇ clinical research thinking,research departments to strive for more high-level clinical trials to improve the enthusiasm of researchers and other measures to solve problems,so as to standardize the operation rules of clinical trials and improve the quality of clinical trials.

关 键 词： 药物临床试验 研究者 调查分析 对策研究