摘要
目的 通过对中药临床试验项目的数据自查,提升临床试验质量,增加新药研发的安全性。方法 参照《国家食品药品监督管理总局关于发布药物临床试验数据现场核查要点的公告(2015年第228号)》《药物临床试验伦理审查工作指导原则》对该院2019年1月至2022年1月开展的31项中药临床试验研究项目、527份研究病例进行自查,其中Ⅱ期临床试验25项,Ⅲ期临床试验6项。对出现的问题进行总结分析,并提出规避措施。结果 方案偏离/违背问题主要有访视超窗[12.14%(64/527)]、检验项目漏做[9.87%(52/527)]、知情同意书不规范[5.50%(29/527)]等。重要问题主要有药物漏服[4.74%(25/527)]、检验异常值未复查[11.76%(62/527)]、检验异常值未判断临床意义[7.78%(61/527)]、与原始数据不一致[6.26%(14/527)]等。一般问题主要有合并用药未填写[5.69%(30/527)]、不良事件填写不完整[3.42%(18/527)]、漏报不良事件[1.71%(9/527)]等。结论 为确保中药临床试验数据的真实性、完整性应进行闭环管理,对中药临床试验的各个环节进行质量控制、反馈、追踪、验收等。
Objective To improve the quality of clinical trials and increase the safety of new drug research and development through self-checking clinical trial data of traditional Chinese medicine(TCM).Methods According to the Announcement of the State Food and Drug Administration on the Release of Drug Clinical Trial Data on-site Verification Points(2015 No.228)and the Guidelines for ethical review of drug clinical trials,31 clinical trial research projects of TCM conducted in this hospital from January 2019 to January 2022 were self-examined,including 527 research cases.There were 25 phaseⅡclinical trials and 6 phaseⅢclinical trials.The Problems were summarized and analyzed,and the circumvention measures were put forward.Results The problems of scheme deviation and scheme violation mainly include that super′s visit to the windows[12.14%(64/527)],inspection items were missed[9.87%(52/527)],and non-standard informed consent[5.50%(29/527)].Important problems mainly include that missed medication[4.74%(25/527)],test outliers were not reviewed[11.76%(62/527)],the test outliers not judged clinical significance[7.78%(61/527)],inconsistent with the original data[6.26%(14/527)],etc.The general problems mainly include that not filled in the combined medication[5.69%(30/527)],incomplete filling in adverse events[3.42%(18/527)],and underreporting adverse events[1.71%(9/527)].Conclusion In order to ensure the authenticity and integrity of clinical trial data of traditional Chinese medicine,closed-loop management should be carried out,including quality control,feedback,tracking,acceptance and so on.
作者
文娱
李晓晖
陈云艳
WEN Yu;LI Xiaohui;CHEN Yunyan(Office of Drug Clinical Trial Institution of Traditional Chinese Medicine,Xiamen Hospital,Beijing University of Chinese Medicine,Xiamen,Fujian 361009,China)
出处
《现代医药卫生》
2024年第3期380-384,共5页
Journal of Modern Medicine & Health
基金
福建省厦门市科技局医疗卫生指导性项目(3502Z20209122)。
关键词
药物临床试验
不良事件
知情同意
依从性
中药
Drug clinical trial
Adverse event
Informed consent
Compliance
Traditional Chinses medicine
