临床事件委员会在不同类型临床研究中不良事件判定一致率的实例评估  

Consistency of Case Evaluation of Adverse Event Adjudications in Various Clinical Studies

作　　者：丁丽娟 尹潞[1] 王丽萍[1] 孙亚亚 胡泊[1] 刘小云[1] 孙毅[1] 李卫[1] DING Lijuan;YIN Lu;WANG Liping;SUN Yaya;HU Bo;LIU Xiaoyun;SUN Yi;LI Wei(Medical Research&Biometrics Center,National Center for Cardiovascular Diseases,Fuwai Hospital,Chinese Academy of Medical Science&Peking Union Medical College,Beijing 102300,China)

机构地区：[1]中国医学科学院,北京协和医学院,阜外医院,国家心血管病中心医学统计部,北京102300

出　　处：《中国药物警戒》2020年第9期625-630,共6页Chinese Journal of Pharmacovigilance

摘　　要：目的比较不同类型临床研究中临床事件委员会和研究者对不良事件判定的差异,以评估临床事件委员会在临床研究中的作用。方法采用中国前瞻性城乡流行病学研究和两项药物临床试验数据,比较临床事件委员会评判结果与各中心研究者上报不良事件结果,并进行不一致率评估。结果中国前瞻性城乡流行病学研究组于2018年2月至2019年6月共计召开11次临床事件委员会议,共评估终点事件1 993例次,临床事件委员会和研究者判断不一致76例次,占3.8%;某药物Ⅰ期临床试验共计上报不良事件20例次,临床事件委员会和研究者判断不一致5例次,占25.0%;某药物Ⅲ期临床试验共计上报不良事件197例次,临床事件委员会和研究者判断不一致48例次,占24.4%。结论本研究结果显示召开临床事件委员会进行不良事件审评,可按统一标准提高多中心临床研究不良事件评估的质量和可靠性。Objective To compare the difference in adjudications of adverse events between the Clinical Event Committee(CEC)and investigators,and evaluate the role of CEC in a wide range of clinical studies.Methods Data about adverse events was collected from the Prospective Urban and Rural Epidemiology study in China(PURE-China)and from two drug clinical trials.Inconsistency between CEC and investigators in various studies was compared and evaluated.Results A total of eleven CEC meetings for PURE-China study were conducted between February 2018 and June 2019,and 1993 end-point events were evaluated.The number of inconsistent adjudications between CEC and investigators was seventy-six,accounting for 3.8%.In a phaseⅠclinical trial,twenty adverse events were reported,five of which were inconsistent(25.0%).In another phaseⅢclinical trial,197 adverse events were observed,24.4%of which were inconsistent(48 adverse events).Conclusion The results of this study indicate that CEC meetings for adverse event adjudications can improve the quality and reliability of adverse event evaluation in multi-center clinical studies using unified criteria.

关 键 词：临床事件委员会 不良事件判定一致率 药物Ⅰ期临床试验 药物Ⅲ期临床试验 

分 类 号：R994.11[医药卫生—毒理学]