生物等效性试验受试者招募困境与解决方法探讨  

Discussion on Difficulties and Solutions in Recruiting Subjects for Bioequivalence Study

作　　者：李丰杉 冯仕银 陈卓[2,3] 王晶[2,3] 邹琴[2,3] 郭伟一[2,3] 蔡林芮 苏旭[2,3] 胡凤 杜丹 杜春凤[2,3] 郑莹[4] 余勤[2,3] LI Fengshan;FENG Shiyin;CHEN Zhuo;WANG Jing;ZOU Qin;GUO Weiyi;CAI Linrui;SU Xu;HU Feng;DU Dan;DU Chunfeng;ZHENG Ying;YU Qin(Office of Ethics Committee of Clinical Trials,West China Second University Hospital,Chengdu 610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Ministry of Education,Ministry of Education;Drug Clinical Trial Institution, West China Second University Hospital, Chengdu 610041, China;Department of Obstetrics and Gynecology, West China Second University Hospital, Chengdu 610041, China)

机构地区：[1]四川大学华西第二医院临床试验伦理专业委员会办公室,四川成都610041 [2]出生缺陷与相关妇儿疾病教育部重点实验室,四川成都610041 [3]四川大学华西第二医院药物临床试验机构,四川成都610041 [4]四川大学华西第二医院妇产科,四川成都610041

出　　处：《中国医学伦理学》2020年第5期575-578,582,共5页Chinese Medical Ethics

摘　　要：受试者招募是生物等效性试验中相互关联且尤为重要的部分,但目前却存在招募工作主要由招募公司/中介完成、招募过程难以监管、某些受试者为获得试验补偿隐瞒试验史、过敏史、病史等问题。产生这些问题的原因包括:社会大众对临床试验的偏见所致的受试者招募困难;生物等效性试验的特殊性等。一方面,消除大众偏见、鼓励临床试验机构自行进行招募工作、出台相关有效政策规范受试者招募过程是解决目前存在问题的有效方式;另一方面,在试验过程中良好的受试者管理可以在保障受试者权益的基础上提升患者依从性,提升受试者参与意愿,减轻受试者招募压力。Subject recruitment is an interrelated and particularly important part of bioequivalence study.However,at present,there are some problems,including:the recruitment is mainly done by recruitment companies/agencies,the recruitment process is difficult to monitor,some subjects conceal the test history,allergy history and disease history in order to obtain compensation for the test,and so on.The reasons for these problems include:the difficulty in recruiting subjects due to the public’s prejudice against clinical trials;the particularity of bioequivalence studies and so on.Eliminating social prejudice for clinical trial,encouraging institution complete recruitment on their own and publishing effective policies to norm subject’s recruitment procedure are effective ways to solve present problems.Besides,good subject management during the trial can improve patient compliance,increase the willingness of participants to participate and reduce the pressure of recruiting subjects on the basis of protecting the rights of the subjects.

关 键 词：生物等效性试验 受试者招募 受试者管理 受试者权益保护 

分 类 号：R-052[医药卫生]