摘要
Abstract
Objective To analyze problems in the management of adverse events during quality control in drug clinical trial institutions,and to improve the quality of clinical trials.Methods Quality control reports from 48 Phase Ⅰ-Ⅳ drug clinical trial projects involving non-healthy subjects(i.e.,patients)conducted at our institution from January to December 2023 were collected.Based on the Good Clinical Practice(GCP)and the Points for Drug Registration Verification and Deter-mination Principles(Drug Clinical Trials)(Trial),statistical analysis was performed on issues related to adverse event man-agement.Results A total of 267 issues related to adverse event management were identified.Among these,problems in ad-verse event determination were the most frequent(197 items,73.78％),including unassessed abnormal values(130 items,48.69％),insufficient basis for determination(46 items,17.23％),inconsistent determination criteria(21 items,7.87％),non-standard documentation(33 items,12.36％),missed reports(22 items,8.24％),lack of follow-up(12 items,4.49％),and unreasonable causality assessment(3 items,1.12％).Conclusion This study systematically analyzes the main causes of problems in adverse event management and proposes measures that institutions should adopt,providing a basis for optimiz-ing quality management in clinical trials.关键词
药物临床试验/质量控制/不良事件Key words
Drug clinical trial/Quality control/Adverse events分类
医药卫生
