生物等效性试验受试者招募影响因素的定性访谈研究  

Qualitative interview on influence factors for subject recruitment in bioequivalence test

作　　者：孙莹[1,3] 蔡秋晗[1,3] 李瑞本 陆艳泓 SUN Ying;CAI Qiu-han;LI Rui-ben;LU Yan-hong(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)

机构地区：[1]天津中医药大学第一附属医院,天津300381 [2]国家中医针灸临床医学研究中心,天津300381 [3]天津中医药大学,天津301617

出　　处：《现代药物与临床》2022年第2期387-390,共4页Drugs & Clinic

基　　金：国家科技重大专项(民口)重大新药创制专项(2020ZX09201-008)。

摘　　要：目的通过定性访谈的方法探索影响生物等效性试验受试者招募的可能因素,以期提高招募速度并为保证入组质量提供参考和思路。方法在天津中医药大学第一附属医院临床试验中心2020年9月—2021年6月开展的生物等效性试验受试者中,随机选择12名受试者作为研究对象,设计半结构式定性访谈提纲,采用个人深度访谈形式,对受试者临床试验整体认知、积极性影响因素两方面进行访谈。结果无医学背景的受访者对临床试验认知相对不足,角色认同感较消极;受访者总体对临床试验的参与持积极态度,影响参与度的因素包含"补偿费用""药物安全性""周期""采血量""个人时间""行程/研究地点""机构硬件设施"和"护理质量"等关键词,其中以"补偿费用"和"试验药物安全性"为主要影响因素。结论科学普及临床试验知识,增加受试者对临床试验的认知;丰富重视知情同意内容,注重沟通,做好安全性风险控制;合理设定受试者补偿费用额度,是可能提高受试者对招募回应度的可行方法。Objective To explore the possible factors affecting the recruitment of subjects in bioequivalence test by qualitative interview,so as to provide reference for improving the recruitment speed and ensuring the quality of enrollment.Methods Among participants of bioequivalence trial conducted in First Teaching Hospital of Tianjin University of Traditional Chinese Medicine in September 2020—June 2021,12 subjects were randomly selected as the research object.Semi-structured qualitative depth interview was done for exploring motivation factors.Results The interviewees without medical background had less cognition of clinical trials,and their role identity was more negative.The factors influencing the participants’participation in clinical trials included"compensation","drug safety","duration","blood volume","personal schedules","study site","hardware facilities","quality of care",and other keywords,and the main influencing factors were"compensation"and"safety".Conclusion It is possible to improve the response of subjects to recruitment by popularizing knowledge of clinical trial and increasing subjects’cognition,enriching the safety content of informed consent,paying attention on security risk control and setting reasonable compensation.

关 键 词：生物等效性试验 一致性评价 招募 定性访谈 

分 类 号：R969[医药卫生—药理学]