从研究者角度谈Ⅰ期临床试验健康受试者的管理和权益保护  

Management and rights/interests protection of healthy subjects from perspective of investigators in phase Ⅰ clinical trial

作　　者：贾晶莹[1] 胡朝英[1] 刘烨[1] 李婷婷[1] 宋蓉[1] 周沁逸 王奕君[1] 徐霄琰 余琛[1] 

机构地区：[1]中国科学院上海临床研究中心/上海市徐汇区中心医院中心实验室,上海200031

出　　处：《中国新药与临床杂志》2015年第2期99-101,共3页Chinese Journal of New Drugs and Clinical Remedies

基　　金：上海市徐汇区青年人才培养计划资助项目(RCKT201205)

摘　　要：Ⅰ期临床试验是药物临床研究的起始阶段,是整个药物研发链中十分重要的一环。Ⅰ期临床试验通常是以健康受试者为主要研究对象的单中心临床研究,健康受试者不但不能获得疾病治疗的益处,还常常需要承受高剂量试验药物所引起的不良反应。对Ⅰ期临床试验受试者的保护应贯穿在试验的整个过程中,从方案设计、伦理审查和知情同意、保险和研究协议、身份识别和个人信息保护、临床观察及安全性评价等方面进行严格管理。As a very important part of the whole drug development chain, phase I clinical trial is the initial stage of drug clinical research. Healthy subjects are usually recruited by a single site for a special phase I clinical study. The healthy subjects could not obtain treatment benefits as patients, instead they often endure the adverse reactions caused by the high dose of investigational medicinal product. The protection for phase I clinical trial subjects should be run through the whole process from protocol design, ethics review and informed consent, insurance and study contract, identity recognition and personal information protection, clinical observation and safety evaluation, all of which need to be strictly managed.

关 键 词：临床试验 Ⅰ期 人类试验 健康受试者 组织和管理 

分 类 号：R951[医药卫生—药学]