佛山市某三甲医院药物临床试验质量现状调查及影响因素分析  

Investigation on the Quality of Drug Clinical Trials and Analysis of Influencing Factors in a Third Class Hospital of Foshan City

作　　者：范燕华 卢结文[1] 梁玉颜[1] 吴杏梅[1] FAN Yanhua;LU Jiewen;LIANG Yuyan;WU Xingmei(Department of Drug Clinical Research Management,Foshan First People's Hospital,Foshan 528000,Guangdong,China)

机构地区：[1]佛山市第一人民医院药物临床研究管理科,广东佛山528000

出　　处：《中国卫生产业》2024年第8期30-33,共4页China Health Industry

摘　　要：目的探讨佛山市某三甲医院药物临床试验质量现状调查及影响因素分析。方法选取2022年1月—2024年1月期间佛山市某医院进行的61项药物临床试验项目进行分析,根据问题发生频次及严重性综合评估试验项目质量,并分别采用单、多因素Logistic回归分析临床试验质量的影响因素。结果61项药物临床试验共涉及262条质量问题。低风险项目与中高风险项目在药物注册分类、临床监查员(clinical research associate,CRA)来源、受试者依从性、CRA的资质经验、临床研究协调员(clinical research coordinator,CRC)更换次数方面比较,差异有统计学意义(P均<0.05)。受试者依从性差、CRC更换次数>3次、CRA资质经验不足均为影响临床试验质量的独立危险因素(OR=1.980、2.056、1.470,P均<0.05)。结论受试者依从性差、CRC更换次数>3次、CRA的资质经验不足均为影响本院近年来临床试验质量独立危险因素,可通过对以上方面进行针对性加强管理,以提高临床试验质量。Objective To investigate the quality of clinical trials in a Grade 3 A hospital of Foshan City and analyze the factors.Methods Sixty-one drug clinical trial projects conducted in a hospital in Foshan City from January 2022 to January 2024 were selected for analysis,and the quality of the trial projects was comprehensively assessed according to the frequency and severity of the problems,and the influencing factors of the quality of the clinical trials were analyzed by using single and multifactorial logistic regression,respectively.Results A total of 262 quality issues were involved in 61 clinical trials of drugs.There were statistically significant differences between low-risk and mediumhigh-risk programs in terms of drug registration classification,source of clinical research associate(CRA),subject compliance,CRA qualification and experience,and number of changes of clinical research coordinator(CRC)(all P<0.05).Poor subject compliance,the number of CRC replacement>3,and the lack of CRA qualification and experience were independent risk factors affecting the quality of clinical trials(OR=1.980,2.056,1.470,all P<0.05).Conclusion Poor subject compliance,CRC replacement>3,and insufficient qualification and experience of CRA are independent risk factors affecting the quality of clinical trials in hospital in recent years.The quality of clinical trials can be improved by targeting and strengthening the management of the above aspects.

关 键 词：临床试验质量 因素分析 临床研究协调员 风险因素 

分 类 号：R7[医药卫生—临床医学]