中国药业2024，Vol.33Issue(14)：13-16,4.DOI:10.3969/j.issn.1006-4931.2024.14.004
药物临床试验中违背方案事件类型分析
Analysis of Types of Protocol Violation Events in Drug Clinical Trials
摘要
Abstract
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.关键词
药物临床试验/违背方案事件/伦理审查/责任主体Key words
drug clinical trial/protocol violation event/ethical review/responsible body分类
医药卫生引用本文复制引用
张梦琦,梁欣,夏瑞,裴宇盛,张亚同..药物临床试验中违背方案事件类型分析[J].中国药业,2024,33(14):13-16,4.基金项目
国家重点研发计划课题[2020YFC2009001]. （）
