摘要
目的根据临床试验质控报告的回顾性分析结果,设置并验证可用于优化数字化监测平台的预警机制。方法将2016—2021年本院肿瘤药物临床试验的常规质控结果导入质控信息数字化系统,按照等级、维度、申办方类型和试验期别进行回顾性统计分析。根据质控结果最优的年度分析数据设置报警阈值,统计和对比6年间的试验报警比例。结果6年间重要及严重结果的总占比从2016年的44.6%下降到2021年的1.2%,最常检出的类型是源数据收集/记录。基于2020—2021年质控结果设置的报警阈值为重要结果>4个或严重结果≥1个;数据类结果占比>60%;安全伦理类结果占比>50%。其中不同年份的试验报警比例存在显著差异(P<0.05),不同申办方和试验期别的试验报警比例无显著差异(P>0.05)。结论本机构所设报警阈值适用于数字化监测平台,肿瘤药物临床试验的质量明显提高。
AIM To set up and validate alarm threshold values that can be used to optimize our institution’s Digital Monitoring Platform for Clinical Trial Quality Control Information,based on retrospective analyses of clinical trial quality control(QC)reports.METHODS Routine oncology clinical trial QC reports generated in our institution from 2016 to 2021 were imported into our Digital Monitoring Platform.Retrospective statistical analysis was conducted according to their own severity,clinical dimension,sponsor type and clinical trial period.The alarm threshold was set according to the annual analysis data with the best quality control results,and the test alarm proportion in 6 years was counted and compared.RESULTS The total proportion of important and serious results in 6 years decreased from 44.6% in 2016 to 1.2% in 2021.The most common type was source data collection/recording.The alarm threshold set based on the quality control results from 2020 to 2021 was more than 4 important results or more than 1 serious result,data results accounted for>60%,and dafety ethics results accounted for>50%.There was a significant difference in the proportion of test alarms in different years(P<0.05),and there was no significant difference in the proportion of test alarms in different sponsors and periods(P>0.05).CONCLUSION The quality of oncology clinical trials conducted in our institute is improved under the monitoring and management of the Digital Monitoring Platform.The alarm thresholds are validated and applicable for the optimization of our Digital Monitoring Platform for Clinical Trial Quality Control Information.
作者
廖春梅
苏叶星
周昌明
陈晶晶
盛源
蒋阳骏
李彻
王文思
刘一婷
龚瑛
刘燕飞
LIAO Chun-mei;SU Ye-xing;ZHOU Chang-ming;CHEN Jing-jing;SHENG Yuan;JIANG Yang-jun;LI Che;WANG Wen-si;LIU Yi-ting;GONG Ying;LIU Yan-fei(Clinical Research Unit,Fudan University Shanghai Cancer Center/Department of Oncology,Fudan University Shanghai Medical College,SHANGHAI 200032,China;Pfizer China Research and Development Co.,Ltd.,SHANGHAI 201203,China;Hangzhou Yikefu Technology Co.,Ltd.,Hangzhou ZHEJIANG 310012,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2022年第12期733-737,共5页
Chinese Journal of New Drugs and Clinical Remedies
基金
上海申康医院发展中心管理研究项目(SKGL2001)。
关键词
临床试验
质量控制
监测
clinical trial
quality control
monitoring
