摘要
目的 分析抗肿瘤药物临床试验中方案违背现状及原因,以减少方案违背的发生。方法 采用回溯性分析、根因分析方法收集本院2023年5月至2024年6月开展99项抗肿瘤药物临床试验项目中的方案违背报告,并对导致方案违背的责任主体、违背行为类型及具体原因进行回顾性分析,从根源上降低方案违背率。结果 99项抗肿瘤药物临床试验项目中累计产生方案违背行为642例次。导致方案违背的责任主体主要是受试者和研究者。方案违背的主要类型有超窗违背、漏做/未做访视或缺失访视中检查/其余操作、药物相关违背、生物样本相关违背、不良事件相关违背、随机系统录入违背等。方案违背的原因主要包括受试者自身因素、研究者对抗肿瘤药物临床试验方案的熟悉度与严谨度、临床研究协调员(CRC)对试验的配合度及质量把控等方面的人为因素,也包括抗肿瘤药物临床试验的材料、环境、流程、申办方,以及节假日等因素。国内申办方项目的方案违背率较国外申办方项目高。结论 方案违背情况在抗肿瘤药物临床试验中仍普遍存在,受试者及研究者是方案违背的主要责任主体,因此亟需加强抗肿瘤药物临床试验的质量控制。对方案违背发生的原因进行深层剖析,提出有效改进措施和指导方向,可以减少方案违背的发生,提高抗肿瘤药物临床试验质量。
Objective To analyze the current situation and causes of protocol deviations in anti-tumor drug clinical tri‐als,in order to reduce the occurrence of protocol deviations.Methods Retrospective analysis and root cause analysis(RCA)were used to collect protocol deviation reports from 99 clinical trials of anti-tumor drugs from May 2023 to June 2024.The responsible subjects,types and specific reasons of protocol deviations were retrospectively analyzed,so as to reduce the in‐cidence of protocol deviations from the root problem.Results 99 clinical trials of anti-tumor drugs had a total of 642 cases of protocol deviations,and the subjects and investigators were mainly responsible for the protocol deviations.The main types of protocol deviations included exceeding the allowed time window of protocols,missed/no visits or lacking of exami‐nations/other procedures in the visit,drug-related deviation,biological samples-related deviation,adverse event(AE)-related deviation,system entry deviation,etc.The main reasons for the protocol deviations included human factors such as subjects'own factors,the investigators'familiarity and rigor with the anti-tumor drug trial protocol,and clinical research coordinator's cooperation and quality control of the trial,as well as the influence of material,environment,process,sponsor,and holidays factors in the drug trial.The occurrence rate of protocol deviations in domestic projects was higher than that of foreign ones. Conclusion Protocol deviations still widespread in clinical anti-tumor drug trials. Subjects and researchers are the main responsible parties for protocol deviations. So it is urgent to strengthen the quality control of drug clinical tri‐als. By making deep analysis of causes and providing guidance for the effective improvement measures, it is expected to re‐duce the protocol deviations and improve the quality of clinical trials of anti-tumor drugs.
作者
金艳
于杨
JIN Yan;YU Yang(Department of Internal Medicine Oncology,Harbin Medical University Cancer Hospital,Harbin,150081,Heilongjiang,China)
出处
《肿瘤药学》
2024年第6期666-672,共7页
Anti-Tumor Pharmacy
关键词
抗肿瘤药物
药物临床试验
方案违背
Anti-tumor drugs
Drug clinical trials
Protocol deviations
