摘要
目的通过调查分析杭州市第一人民医院国家药物临床试验机构(以下简称机构)抗肿瘤药物临床试验方案偏离的情况,为提高临床试验质量提供参考。方法对2017—2019年度该机构运行的18项抗肿瘤药物临床试验的方案偏离进行回顾性研究,探讨方案偏离的类别、例次、责任方、对受试者及对关键数据的影响,分析产生方案偏离的原因,并提出改进措施。结果18项抗肿瘤药物临床试验,共筛选受试者137例,入组受试者75例,出现120例次方案偏离情况。发生的方案偏离类别主要为研究程序/评估不符合流程占42.50%(51/120)、研究药物使用或管理不当占16.67%(20/120)、SAE报告不及时占15.00%(18/120)、受试者访视/检查超窗占14.17%(17/120)。显著影响受试者权益/安全的方案偏离占3.33%(4/120),显著影响关键数据的完整性/准确性方案偏离占0.83%(1/120)。研究者责任占56.67%(68/120)、受试者责任占29.17%(35/120)、申办方责任1.67%(2/120)、申办方和研究者共同承担责任占12.50%(15/120)。结论该研究分析了抗肿瘤药物临床试验中常见的方案偏离情况,提出有效减少方案偏离的措施,为提高抗肿瘤药物临床试验质量提供借鉴。
Objective To analyze the protocol deviations in oncology registration clinical trials in National drug clinical trial institution of Hangzhou First People's hospital,and to provide a reference for improving the quality of clinical trials.Methods Protocol deviations from 18 projects were retrospectively studied during 2017-2019.Results A total of 18 anti-tumor drug clinical trials were implemented in our hospital,and 137 subjects including 75 cases were screened,from which 120 deviations were reported.The types of the deviations that occurred were mainly 42.50%(51/120)of research procedures/assessment non-conformance processes,16.67%(20/120)of study drug use or improper management,15.00%(18/120)of untimely SAE reports,and 14.17%(17/120)of subjects’visit/inspection overdue,respectively.The protocol deviations that significantly affect the rights and safety of subjects accounted for 3.33%(4/120),and the protocol deviations that significantly affected the integrity/accuracy of key data accounted for 0.83%(1/120).The deviations which were attributable to the clinical research team accounted for 56.67%(68/1200),to subject accounted for 29.17%(35/120)to sponsor accounted for 1.67%(2/120),and to both clinical research team and sponsor accounted for 12.50%(15/120).Conclusion This study analyzes the common deviations of the protocols in the clinical trials of anti-cancer drugs,and proposes effective measures to reduce deviations from the protocols,thus providing a reference for improving the quality of clinical trials of anti-cancer drugs.
作者
叶丽君
蔡淑帆
林能明
王飞
YE Lijun;CAI Shufan;LIN Nengming;WANG Fei(The Office of Clinical Trial Management,Hangzhou First People's Hospital Affiliated to Medical College,Zhejiang University,Hangzhou 310006,China;Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province,Hangzhou First People's Hospital Affiliated to Medical College,Zhejiang University,Hangzhou 310006,China)
出处
《医药导报》
CAS
北大核心
2021年第12期1761-1765,共5页
Herald of Medicine
基金
浙江省临床肿瘤药理与毒理学研究重点实验室资助项目(2020E10021)。
关键词
抗肿瘤药物
临床试验
方案偏离
预防纠正措施
Anti-tumor drugs
Clinical trial
Corrective action
Protocol deviation
Preventive action
