摘要
目的分析特殊药品临床试验现状及质控情况,探究提升特殊药品临床试验质量的策略。方法收集2021—2024年国家药品监督管理局药品评审中心的药物临床试验登记与信息公示平台及武汉市某三甲医院药物临床试验机构登记的所有特殊药品临床试验项目,分析特殊药品临床试验项目数量变化趋势,从临床试验各环节和责任主体角度对某医院特殊药品临床试验项目质控情况及质控过程中发生率较高的问题进行分类统计。通过专家访谈进行定性分析,识别特殊药品临床试验过程中的关键风险点并探究成因。结果2021—2024年全国特殊药品临床试验项目总量为467项,武汉市某医院共46项,约占全国总量的1/10。46项中涉及毒性药品和放射性药品的临床试验项目呈现逐年稳定上升趋势,涉及麻醉药品和精神药品的临床试验项目数量呈现年度波动特征。在特殊药品临床试验项目中,经过质量评估的共有22项,发现问题58次。出现的问题及频率最高的4项分别为临床试验数据记录和报告(27.6%)、安全性信息处理与报告(22.4%)、试验用药品管理(17.2%)和筛选入组及方案执行(12.1%)。管理问题出现频率最高的责任主体为研究者(38次)。专家认为特殊药品临床试验中研究者管理风险形成的主要原因为研究者过度依赖临床研究协调员及特殊药品临床试验管理法规不完善。结论某医院特殊药品临床试验项目数量根据药物种类不同呈现不同的年度变化趋势,临床试验项目中的质量问题主要集中在各项记录的错记漏记及药品管理方面。应完善特殊药品临床试验管理规定,提高临床试验研究者责任意识,发展信息化智能化质量管理平台。
Objective The study attempts to analyze the current situation and quality control of clinical trials of special drugs,and to explore strategies to improve their quality.Methods This study collected clinical trial data from the Drug Clinical Trial Registration and Information Disclosure Platform of the Center for Drug Evaluation(CDE)under China's National Medical Products Administration(NMPA)from 2021 to 2024,along with registration records of special drug clinical trial programs in a tertiary hospital.The analysis focused on the quantitative trends of these special drug trials,conducted a categorized statistical review of quality control measures and recurring issues across all trial phases and accountable parties.Additionally,through expert interviews,the research identified critical risk points in the clinical trial and investigated their underlying causes.Results From 2021 to 2024,China conducted 467 clinical trials for special drugs,and the study hospital accounted for 46 cases—approximately one-tenth of the national total.Trials involving toxic medical drugs and radioactive drugs showed steady annual growth,while those related to narcotic and psychotropic drugs exhibited fluctuating patterns.Among them,22 underwent quality assessments with 58 issues identified during the process.The top four recurring problems were clinical trial data recording and reporting(27.6%),safety information processing and reporting(22.4%),investigational drug management(17.2%)and screening enrollment,and protocol execution(12.1%).Investigators were the most frequent source of management issues,with 38 reported cases.Experts attributed the primary risks to investigators’over-reliance on Clinical Research Coordinators(CRC)and inadequate regulatory frameworks for special drug trials.Conclusions The number of clinical trial projects for special drugs at the study hospital shows varying annual trends depending on the drug type.Quality issues in these trials mainly involve errors and omissions in recording and drug management practices.To address this,it is essential to refine clinical trial management regulations,enhance investigators’accountability awareness,and develop intelligent quality management platforms through digitalization.
作者
吴建才
王萌萌
刘巧玲
胡文心
卢单华
王华美
张达
WU Jiancai;WANG Mengmeng;LIU Qiaoling;HU Wenxin;LU Danhua;WANG Huamei;ZHANG Da(Drug Clinical Trial Institution,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430000,Hubei,China)
出处
《健康发展与政策研究》
北大核心
2025年第6期661-666,共6页
Health Development and Policy Research
基金
湖北省卫生健康科研项目(WJ2023M039)。
关键词
临床试验
特殊药品管理
质控
常见问题
数据管理
clinical trials
special drug management
quality control
common problems
data management
