健康发展与政策研究2025，Vol.28Issue(6)：661-666,6.DOI:10.12458/HDPR.202503063
武汉市某三甲医院特殊药品临床试验现状及质控情况分析
The status quo and quality control of clinical trials of special drugs in a tertiary hospital in Wuhan
摘要
Abstract
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.关键词
临床试验/特殊药品管理/质控/常见问题/数据管理Key words
clinical trials/special drug management/quality control/common problems/data management分类
医药卫生引用本文复制引用
吴建才,王萌萌,刘巧玲,胡文心,卢单华,王华美,张达..武汉市某三甲医院特殊药品临床试验现状及质控情况分析[J].健康发展与政策研究,2025,28(6):661-666,6.基金项目
湖北省卫生健康科研项目(WJ2023M039) （WJ2023M039）
