文章摘要
陈仙萍,张 静,汪卓赟,鲁 超.药物临床试验违背方案影响因素模型构建[J].南京医科大学学报(社会科学版),2021,(4):361~365
药物临床试验违背方案影响因素模型构建
Construction of a model of influencing factors of illegal events in drug clinical trials
投稿时间:2021-04-19  
DOI:doi:10.7655/NYDXBSS20210410
中文关键词: 扎根理论  违背方案  影响因素
英文关键词: grounded theory  illegal event  influencing factor
基金项目:安徽省中医药管理局中医药传承创新科研项目(中医药课题)“金雀根治疗类风湿关节炎的作用及分子机制研究”(2020cczd05)
作者单位
陈仙萍 安徽医科大学第二附属医院管理教研室安徽 合肥 230601 
张 静 安徽医科大学第二附属医院科研部安徽 合肥 230601 
汪卓赟 安徽医科大学第二附属医院管理教研室安徽 合肥 230601 
鲁 超 安徽医科大学第二附属医院管理教研室安徽 合肥 230601 安徽理工大学医学院 安徽 淮南 232001 
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中文摘要:
      为深入探究影响药物临床试验违背方案发生的因素,以扎根理论为基础对安徽省某大型综合医院2017—2019年药物临床试验违背方案记录进行整理分析,构建药物临床试验违背方案影响因素模型。结果显示,“药物临床试验风险预控”与“药物临床试验前提基础”对违背方案的发生存在显著影响。建议提升研究环境资源条件,加强研究者及研究团队相关培训,合理设计研究方案。建立安全监测系统,完善不良事件报告处理机制,引导研究人员道德伦理意识观念深层转变,为减少临床试验违背方案的发生,控制药物临床试验质量提供一定的思路和建议。
英文摘要:
      In order to deeply explore the factors that affect the occurrence of illegal events in drug clinical trials, this study used the grounded theory to sort out and analyze the illegal records of drug clinical trials during 2017—2019 in a large general hospital in Anhui Province and construct a model of influencing factors of illegal events in drug clinical trials. The results showed that “pre?control of drug clinical trial risks” and “prerequisite basis for drug clinical trials” had significant impact on the occurrence of plan violations. It is recommended to improve the research environment and resource conditions, strengthen the relevant training of researchers and research teams, and rationally design research plans. It is suggested to establish a safety monitoring system, improve the reporting and handling mechanism for adverse events, guide researchers to deepen the transformation of moral concepts, and provide some ideas and suggestions for reducing the occurrence of illegal events in clinical trials and controlling the quality of drug clinical trials.
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