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,7.54%)违背方案事件发生较多,且主要发生于Ⅱ期及Ⅲ期药物临床试验阶段;责任主体主要为受试者(544 例次,50.05%)和研究者(344 例次,31.65%);产生影响的违背方案事件发生率较低,其中影响受试者安全15 例次(1.38%),影响受试者权益和显著影响研究结果均为 9 例次(0.83%);共涉及 108 个申办项目,其中国内申办项目较多(97 项),国外申办项目中发生知情同意签署、生物样本管理、受试者筛选入组及方案执行的违背方案事件数量均显著少于国内申办项目(P<0.05).结论 建议机构及申办方加强对研究者《药物临床试验质量管理规范》和试验方案设计的培训,医院药物临床试验伦理委员会需加强对违背方案的监管,从而减少试验过程中违背方案事件的发生,保障受试者的安全和权益,提高药物临床试验质量.
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 total of 304 protocol violation reports were included,involving 1 087 case times of protocol violation events,mainly involving subjects' screening,enrollment and protocol implementation(597 case times,54.92% ),failure to use drugs according to the protocol(305 case times,28.06% ),management of drugs for clinical trials(82 case times,7.54% ),and the above protocol violation events mainly occurred during the phases Ⅱ andⅢ of drug clinical trials.The main responsible bodies were the subjects(544 case times,50.05% )and researchers(344 case times,31.65% ).The incidence of protocol violation events having an effect was low,in which 15 case times affecting the safety of subjects(1.38% ),nine case times affecting the equities of subjects(0.83% ),nine case times significantly affecting the research results(0.83% ).A total of 108 sponsoring projects were involved,including more domestic projects(97 ones).The quantity of protocol violation events such as informed consent signing,biological sample management and subjects' screening,enrollment and protocol implementation in foreign sponsoring projects was significantly smaller than that in domestic projects(P<0.05).Conclusion It is recommended that institutions and sponsors should strengthen the training for researchers on the Good Clinical Practice and trial protocol design,the Hospital Drug Clinical Trial Ethics Committee need to strengthen the supervision of protocol violations to decrease the occurrence of protocol violation events during the trials,ensure the safety and equities of subjects,and improve the quality of drug clinical trials.
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 (014)
13-16 / 4
国家重点研发计划课题[2020YFC2009001].
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