摘要
目的:研究药物临床试验不良事件监管过程中存在的问题。方法:通过查阅机构临床试验相关资料,分析2011年至2016年承担的完成临床部分的Ⅱ-Ⅳ期及上市后再评价药物临床试验中不良事件的监管质量。结果:对165项药物临床试验的所有不良事件及其中的39人次严重不良事件整理后,获得实验室检查类不良事件有无漏记、原始病历和病例报告表的不良事件记录一致性、不良事件跟踪及复查情况、不良事件记录的及时率、严重不良事件是否按规定时间上报5个监控问题影响因素的相关数据。结论:现有药物临床试验安全性评价体系尚存在一定问题,要解决这些问题,必须加强研究者的培训和全方位的过程管理。
AIM： To investigate the issues of regulatory issues of adverse events in drug clinical trials. METHODS： The supervisory quality of adverse events in phase Ⅱ-Ⅳ drug clinical trials and those for post-marketing drug assessment with finished clinical section from 2011 to 2016 was analyzed by referring to clinical trial materials in the institution. RESULTS： The related data of influencing factors in 5 monitoring aspects including recording integrity of adverse events for laboratory examination,consistency of records between source data and case report form,their follow-up visit and review,on-time rate of documentation,and reporting situation of serious adverse events were collected in all the adverse events in 165 drug clinical trials and 39 serious ones among the total. CONCLUSION：There are still some problems in the current safety evaluation system of drug clinical trials. It is imperative to strengthen the training of investigators and allround process management in order to find a solution to these issues.
作者
彭朋
元唯安
胡薏慧
汤洁
蒋健
PENG Peng;YUAN Wei~n;HU Yihui;TANG Jie;JIANG Jian(National Drug Clinical Trial Institution, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China)
出处
《中国临床药理学与治疗学》
CAS
CSCD
2018年第1期78-82,共5页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
国家"重大新药创制"科技重大专项创新药物研究开发技术平台建设(2012ZX09303009-001)
上海市中医药事业发展三年行动计划项目(ZY3-CCCX-2-1003)
关键词
临床试验
不良事件
安全性评价
drug clinical trial
adverse event
safety evaluation
