药物临床试验受试者依从性的影响因素及受试者保障体系的建立  

Influencing factors of subjects compliance in drug clinicaltrials and establishment of subject protection system

作　　者：杨玥 蔡名敏 陈红[1] 张如梦 陈希 王桂梅[1] 谢波[1] 王慧萍[1] YANG Yue;CAI Mingmin;CHEN Hong;ZHANG Rumeng;CHEN Xi;WANG Guimei;XIE Bo;WANG Huiping(Clinical Trial Institution Office,Zhongda Hospital,Southeast University,Nanjing,Jiangsu 210009,China)

机构地区：[1]东南大学附属中大医院临床试验机构办公室,江苏南京210009

出　　处：《中国临床研究》2023年第10期1572-1576,共5页Chinese Journal of Clinical Research

基　　金：江苏省药品监督管理局科研计划课题(202106)。

摘　　要：目的 探讨多角度考察药物临床试验中受试者依从性情况,系统分析影响因素,并建立全过程受试者保障体系。方法 收集并整理2018年6月至2021年6月在东南大学附属中大医院实施的40项药物临床试验中的445例受试者资料,以临床依从性和服药依从性为评价指标,从试验方案、个人因素、治疗因素及其他四个方面分析受试者依从性的影响因素。结果 单因素分析显示,项目类型、随访次数、设计日记卡情况、治疗环境、有无不良事件发生为受试者服药依从性的影响因素(P<0.05);对照设计、年龄、病情程度为受试者临床依从性的影响因素(P<0.05);试验分期、盲法设计、试验周期、给药途径、有无家属陪同、有无严重不良事件发生为受试者临床依从性和服药依从性的影响因素(P<0.05)。结论 结合结果分析,总结进而提出了优化试验方案设计、完善试验药物设计、合理筛选受试人群、充分进行知情同意、建立良好医患关系、加强受试者依从性培训、重视试验过程管理等提高受试者依从性的相应措施。Objective To investigate the compliance status of subjects in drug clinical trials from multiple perspectives,analyze the influencing factors systematically,and establish a full-process subject protection system.Methods The data of 445 subjects from 40 clinical trials conducted in Zhongda Hospital Southeast University from June 2018 to June 2021 were enrolled and sorted out,and with clinical compliance and medication compliance as evaluation indicators,the influencing factors of subjects compliance were analyzed from four aspects,including trial schemes,personal factors,treatment factors and others.Results Univariate analysis showed that the project type,number of follow-up,diary card design,treatment environment,and whether adverse events occurred were the influencing factors of the subjects medication compliance(P<0.05);the control design,age,and disease degree were the influencing factors of the subjects clinical compliance(P<0.05);and the trial stage,blinded design,trial cycle,route of administration,whether family members being accompanied or not,and whether serious adverse events occurred were the influencing factors of the subjects clinical compliance and medication compliance(P<0.05).Conclusion Based on the analysis of the results,corresponding measures to improve the compliance of the subjects were summarized and put forward,such as optimizing the design of the trial scheme,perfecting the design of trial drugs,rationally screening the subjects,fully giving informed consent,establishing a good doctor-patient relationship,strengthening the compliance training of the subjects,and attaching importance to the management of the trial process.

关 键 词：药物临床试验 受试者依从性 影响因素 受试者保障体系 

分 类 号：R95[医药卫生—药学]