药物生物等效性临床试验中方案偏离的分析与改进  

Analysis and Improvement on Protocol Deviation in Bioequivalence Trials

作　　者：陈莹蓉[1] 叶丽冰 田孟丽 杨水新[1] CHEN Ying-rong;YE Li-bing;TIAN Meng-li;YANG Shui-xin(Huzhou Central Hospital)

机构地区：[1]湖州市中心医院

出　　处：《医院管理论坛》2024年第1期71-73,70,共4页Hospital Management Forum

基　　金：湖州市科技计划公益性应用研究项目,编号:2021GZ71。

摘　　要：目的 研究药物生物等效性临床试验实施中发生方案偏离的原因,并探讨解决对策,为提高临床试验质量提供依据。方法 以方案偏离的年度分布、发生率和类别为评价指标,分析造成方案偏离现象的原因,并提出解决对策。结果 2018年1月至2022年12月湖州市中心医院共开展生物等效性试验项目27个,发生方案偏离项目23个,共计229例次。发生方案偏离的类别主要为血样采集过程(59.40%)、违反试验流程(33.17%)和生物样本管理(7.43%)。结论 建议组建职业化的临床试验人才队伍,建立完善的质量管理体系;研究人员应持续学习和培训,严格遵循GCP原则及试验方案,减少方案偏离的发生。Objective To study the causes of protocol deviation in the implementation of drug bioequivalence clinical trials, and to explore the countermeasures, so as to provide a basis for improving the quality of clinical trials. Methods Based on the annual distribution, incidence and categories of protocol deviation, the causes of the deviation were analyzed, and the countermeasures were proposed. Results From January 2018 to December 2022, a total of 27 bioequivalence trial projects were carried out in Huzhou Central Hospital, and 23 protocol deviations occurred, with a total of 229 cases. The main categories of protocol deviation were blood sample collection process(59.40%), violation of trial procedures(33.17%) and biological sample management(7.43%). Conclusion It is suggested to establish a professional clinical trial talent team and establish a thorough quality management system. Researchers should continue to learn and train, and strictly follow the principles of GCP and the trial protocol to reduce the occurrence of protocol deviation..

关 键 词：药物临床实验 生物等效性试验 方案偏离 

分 类 号：R197.3[医药卫生—卫生事业管理]