药物临床试验中违背方案事件类型分析OACSTPCD
Analysis of Types of Protocol Violation Events in Drug Clinical Trials
目的 促进药物临床试验质量的提升.方法 提取医院药物临床试验伦理委员会 2019 年 5 月至 2023 年 5 月接收的药物临床试验违背方案报告,分析违背方案事件的类型、责任主体、发生时间、产生的影响,并比较国内外申办项目违背方案事件的发生情况.结果 共纳入违背方案报告 304 份,涉及违背方案事件 1 087 例次,以受试者筛选入组及方案执行(597 例次,54.92%),未按方案用药(305 例次,28.06%),试验用药品管理(82 例次…查看全部>>
Objective To improve the quality of drug clinical trials.Methods The protocol violation reports in drug clinical trials received by the Hospital Drug Clinical Trial Ethics Committee from May 2019 to May 2023 were extracted,the types,responsible body,occurrence time and effect of protocol violation events were analyzed,and the occurrence of protocol violation events in drug clinical trials supported by domestic and foreign sponsors was compared.Results A tota…查看全部>>
张梦琦;梁欣;夏瑞;裴宇盛;张亚同
首都医科大学附属北京潞河医院,北京 101149首都医科大学附属北京潞河医院,北京 101149首都医科大学附属北京潞河医院,北京 101149中国食品药品检定研究院,北京 100050北京医院,北京 100730
药学
药物临床试验违背方案事件伦理审查责任主体
drug clinical trialprotocol violation eventethical reviewresponsible body
《中国药业》 2024 (14)
13-16,4
国家重点研发计划课题[2020YFC2009001].
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