风湿性疾病药物临床试验中常见方案偏离及分析  

Analysis of common protocol deviations in drug clinical trials of rheumatism

作　　者：刘燕[1] 白洁[1] 穆艳飞 郑莎莎[1] 张晓英[1] 王晓霞[1] Liu Yan;Bai Jie;Mu Yanfei;Zheng Shasha;Zhang Xiaoying;Wang Xiaoxia(Department of Rheumatology and Immunology,the Second Hospital of Shanxi Medical University,Taiyuan 030001,China)

机构地区：[1]山西医科大学第二医院风湿免疫科,太原030001

出　　处：《中华风湿病学杂志》2023年第6期393-397,共5页Chinese Journal of Rheumatology

摘　　要：目的分析风湿性疾病药物临床试验中常见方案偏离,为提高临床试验质量、保护受试者安全和权益提供借鉴。方法收集山西医科大学第二医院风湿免疫科2017一2021年开展且已完成项目的方案偏离报告进行归纳整理。结果常见的方案偏离及占比依次为研究程序(25.4%,44/173)用药依从性低(23.7%,41/173)、访视或检查超窗(19.1%,33/173)、访视错过或检查未做(17.9%,31/173)、使用违禁用药(9.2%,16/173)违背入选标准或符合排标准(4.6%,8/173)等。按照方案偏离的严重程度,轻度135例次,严重38例次。5例受试者数据在统计分析时从符合方案集中剔除。结论①研究者层面应持续加强培训,在临床试验设计时兼顾可操作性;在实施过程中严格把握人排标准、按照方案规定的程序进行随访。②机构层面应积极推进医院信息化建设、系统地减少研究者在操作层面的方案偏离。③加强受试者的宣教和管理以保证其依从性,切实提高临床试验质量、保障受试者的安全及权益。④加强监查员的管理,注重监查发现问题.Objective The common protocol deviation(PD)in clinical trials of drugs for rheumatic diseases were analyzed to provide reference for improving the quality of clinical trials and protecting the safety and rights of subjects.Methods Protocol deviation(PD)reports of completed projects conducted by Department of Rheumatology and Immunology,the Second Hospital of Shanxi Medical University,from 2017 to 2021 were collected and sorted out for analysis.Results The common PD and proportion of deviation were deviation from protocol study procedures(25.4%,44/173),low medication compliance(23.7%,41/173),visits out of the scheduled visit dates or the tests or examinations out od the inspection window period(19.1%,33/173),missed visit or missed laboratory tests(17.9%,31/174),using of prohibited drugs(9.2%,16/173)and violation of inclusion criteria or exclusion criteria(4.6%,8/173).135 cases were mild and 38 cases severe deviation.PPS was eliminated in 5 subjects during statistical analysis.Conclusion① Investigator training should be strengthened and the operability should be taken into account in clinical trial design.In the implementation process,the inclusion and exclusion criteria should be strictly followed and the should adherent to study procedures.②The institution should actively promote the development of hospital information system to reduce investigator associated PD.③The education and management of subject should be strengthened to ensure their compliance and improve the quality of clinical trials to protect the safety and rights of subjects.④Institute should strengthen the management of trail supervisors and emphasis on problems identification during inspections.

关 键 词：风湿性疾病 临床试验 方案评价 

分 类 号：R969[医药卫生—药理学]