我院药物临床试验受试者管理分析及对策  

Analysis and countermeasures of subjects management in drug clinical trials

作　　者：张莉[1] 郭晋敏[1] 康长清[1] 徐建江[1] 

机构地区：[1]济南军区总医院药剂科,山东济南250031

出　　处：《中国医药导报》2015年第6期140-144,共5页China Medical Herald

摘　　要：目的分析药物临床试验中影响受试者管理的主要因素,探讨提高受试者招募及依从性的策略。方法回顾性分析济南军区总医院2008年1月-2014年10月40项药物临床试验资料,共1351例受试者。对受试者招募完成率及其影响因素、受试者脱落原因及其影响因素进行分析。结果国际多中心临床试验的招募完成率高于国内项目,可能与其委托合同研究组织（CRO）、配备临床研究协调员（CRC）以及设计多样化的招募方式有关。脱落受试者76例,失访和疗效欠佳是最主要的脱落原因。影响受试者脱落的主要因素有受试者个人因素、环境因素、疾病因素及药物因素等。年龄〉65岁者、外地、病情严重、发生不良反应、门诊受试者的脱落率高于其他受试者（P〈0.05）。口服药物的脱落率高于注射和吸入药物（P〈0.05）。结论通过优化试验方案、接待潜在受试者、发展潜在受试者以及充分知情来提高招募质量及效率。受试者依从性管理细化至试验各阶段,包括试验早期进行依从性预评估、充分知情和依从性教育,试验实施阶段通过建立联络表、随访卡、爱心卡、用药日记卡及坚持持续督导,并且临床常规为受试者提供健康教育及咨询服务。Objective To analyze the main factors influencing subject management in drug clinical trials, and explore strategies on improvement of subjects recruitment and compliance. Methods Retrospective analysis was conducted on 1351 drug clinical trail cases from January 2008 to October 2014 in Ji＇nan Military General Hospital, including 1351 patients. Subject recruitment rate, causes and influencing factors of drop-out were analyzed. Results In international trail, the rate of recruitment was higher than that in domestic trail, possibly due to entrusting contract research organization（CRO）, deploying clinical research coordinator（CRC） and designing diversified recruitment methods. Among1351 cases, there were 76 drop-outs, with the lost and poor drug efficacy as the main reasons of drop-out. Personal reasons, environment, disease and drug reasons were main factors influencing drop-out. In patients aged older than 65,out-of-town, seriously ill, with adverse events, among outpatients had a greater number of drop-out cases than those in others（P 〈0.05）. Drop-out rate of patients with medication orally was significant more than both patients with medication by injection and by inhalation（P 〈0.05）. Conclusion Optimizing pilot, informing fully consent, receiving and developing potential subjects are effective countermeasures to promoting quality and efficiency of recruitment. Subject compliance management should be refined in various stages, including evaluation of compliance, full informant, compliance education in early-stage, implementation of contact list, follow-up cards, love cards, medication diary cards, continuous supervision in the implementation stage, and health education and consulting services provided in clinic routinely.

关 键 词：受试者管理 招募 脱落 依从性 药物临床试验 

分 类 号：R95[医药卫生—药学]