摘要
目的:总结分析广东省药物临床试验机构2020年药物临床试验开展情况以及2018—2020年药物临床试验质量管理规范实施效果评估过程中发现的问题。方法:收集广东省79家药物临床试验机构2020年开展药物临床试验项目数据以及2018—2020年药物临床试验管理规范实施效果现场评估检查结果,按照相关检查标准对现场检查问题进行归类与统计分析。结果:广东省79家药物临床试验机构2020年开展药物临床试验项目立项1 454项,在研2 551项,完成406项,其中广州市立项、在研、完成项目数量分别占全省总量的72.70%,76.99%,74.38%。汇总2018—2020年广东省药物临床试验机构质量管理规范实施效果现场评估检查情况,共发现问题852项,其中一般问题797项,主要问题55项,严重问题0项。药物临床试验机构方面、伦理委员会方面、专业组方面均以规范化建设问题为主,占比分别是55.83%,68.26%,50.29%,项目组方面则以数据管理问题为主,占比为41.22%。结论:2020年广东省药物临床试验项目集中分布在广州市,特别是广州市的优势机构。2018—2020年评估结果显示,规范化建设问题主要影响广东省药物临床试验质量管理规范的实施效果。为提高药物临床试验质量,建议加强临床试验机构组织架构建设以及研究人员、伦理委员会培训,完善药物临床试验机构以及各专业组的管理制度和标准操作规程(SOP)等。
Objective: To summarize and analyze the drug clinical trials carried out by drug clinical trial institutions in Guangdong province in 2020 and the problems on the implement effect evaluation of Good Clinical Practice in Guangdong province from 2018 to 2020. Methods: The data of 79 drug clinical trial institutions in Guangdong province in 2020 and the results on the implement effect evaluation of Good Clinical Practice in Guangdong province from 2018 to 2020 were collected. The unqualified problems were subsequently classified and statistically analyzed according to the relevant inspection standards. Results: According to the statistics of the results of 79 drug clinical trial institutions in Guangdong province in 2020, 1 454 drug clinical trial projects were established, 2 551 under research and 406 completed. The projects established, under research and completed in Guangzhou account for 72.70%, 76.99% and 74.38% in Guangdong province, respectively. Through the evaluation of Good Clinical Practice in clinical trial institutions from 2018 to 2020, 852 problems were found, including 797 general problems, 55 main problems and 0 serious problems. In terms of drug clinical trial institutions, ethics committee and professional group, the main problems were the construction of standardization, accounting for 55.83%, 68.26% and 50.29%, respectively. While in terms of project group, the main problems were data management, accounting for 41.22%. Conclusion: The drug clinical trial projects by 2020 in Guangdong province were concentrated in Guangzhou, especially in the dominant institutions in Guangzhou. The evaluation results from 2018 to 2020 show that the construction of standardization mainly affects the evaluation on implement effect of Good Clinical Practice in Guangdong province. In order to improve the quality of drug clinical trials, it is suggested to strengthen the construction of organizational structure of clinical trial institutions and the training of investigators and ethics committee, and improve the management system and SOP of drug clinical trial institutions and professional groups, etc.
作者
黎金海
司徒冰
张勋
郑志华
邹燕琴
LI Jin-hai;SITu Bing;ZHANG Xun;ZHENG Zhi-hua;ZOU Yan-qin(The Third Afiliated Hospital of Guangzhou Medical University,Guangzhou 510150,China;Clinical Trials Committee of Guangdong Pharmaceutical Association,Guangzhou 510080,China;Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,China;Guangdong Pharmaceutical Association,Guangzhou 510080,China;Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangzhou 510120,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第9期878-884,共7页
Chinese Journal of New Drugs
基金
广东省医学科研基金资助项目(A2020469)。
关键词
临床试验
评估检查
质量控制
clinical trial
effect evaluation
quality control
作者简介
黎金海,男,硕士,主管药师,研究方向:药物临床试验管理。联系电话:(020)81292090,E-mail:253153903@qq.com。;通讯作者:邹燕琴,女,硕士,副研究员,研究方向:药物临床试验管理。联系电话:(020)81332736,E-mail:zyqin72@126.com。
