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 asso-ciate,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.
Investigation on the Quality of Drug Clinical Trials and Analysis of Influ-encing Factors in a Third Class Hospital of Foshan City
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 accord-ing 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 medium-high-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 im-proved by targeting and strengthening the management of the above aspects.
Clinical trial qualityFactor analysisClinical research coordinatorRisk factor
万方数据
维普
