中国临床药学杂志2024，Vol.33Issue(12)：896-900,5.DOI:10.19577/j.1007-4406.2024.12.003
基于现场核查报告探究药物临床试验质量提升与风险控制策略
Exploration of quality improvement and risk control strategies in drug clinical trials based on on-site inspection reports
孙玮 1李慧 1李雪宁1
作者信息
- 1. 复旦大学附属中山医院临床试验机构,上海 200032
- 折叠
摘要
Abstract
AIM To explore strategies to improve the quality and risk control of drug clinical trials.METHODS On-site inspection reports about drug clinical trials in the hospital from 2016 to 2023 were amassed.These reports served as the cornerstone for a comprehensive analysis,guided by the extant regulatory frameworks and inspection guidelines.The identified issues were categorized and discussed.Concurrently,a Pareto diagram was constructed,mapping the frequency distribution of the problems unearthed during the on-site inspections.Subsequently,the risk factors were identified according to the"80/20 rule".RESULTS There were 104 problems in 27 reports of on-site inspections of drug clinical trials from 2016 to 2023.The main risk factors were subject screening and enrollment,along with protocol implementation(32.7％),investigational product management(50.0％),safety information processing and reporting mechanisms(64.4％),biological sample management and central laboratory operations(75.0％).CONCLUSION During the implementation of drug clinical trials,it is incumbent upon both investigators and clinical trial institutions to perform their respective roles,enhance their sense of responsibility,attach importance to training,strengthen research team building,and enhance quality control capabilities and efficiency.By concertedly implementing these measures,quality control and risk management of clinical trials can be strengthened.关键词
药物临床试验/现场核查/常见问题/质量控制Key words
drug clinical trial/on-site inspection/common problem/quality control引用本文复制引用
孙玮,李慧,李雪宁..基于现场核查报告探究药物临床试验质量提升与风险控制策略[J].中国临床药学杂志,2024,33(12):896-900,5.
