早期抗肿瘤药物临床试验受试者风险管理  

Risk management of subjects in early anti-cancer drug clinical trials

作　　者：邓俊 衡建福 陈勇 李东芳 王静 李坤艳 DENG Jun;HENG Jianfu;CHEN Yong;LI Dongfang;WANG Jing;LI Kunyan(The Affiliated Cancer Hospital of Xiangya School of Medicine,Central South University/Hunan Cancer Hospital,Changsha,410006,Hunan,China)

机构地区：[1]中南大学湘雅医学院附属肿瘤医院/湖南省肿瘤医院,湖南长沙410006

出　　处：《肿瘤药学》2023年第4期455-460,共6页Anti-Tumor Pharmacy

基　　金：湖南省自然科学基金科卫联合基金(2021JJ70099);湖南省肿瘤医院科研攀登计划项目(2020IITB001)。

摘　　要：以保障受试者权益为核心,为提高药物临床试验质量,加快早期临床试验成果转化,保障临床试验进程,文章分别从早期药物临床试验中受试者权益保护及质量控制中的受试者管理两个方面探讨受试者的风险管理,并结合药物临床试验质控中受试者风险管理新模式提出受试者风险管理策略,以进一步提高临床试验主体在参与临床试验过程中对受试者的风险管理意识。In order to take the protection of subjects'rights and interests as the core,improve the quality of drug clini‑cal trials,accelerate the transformation of early clinical trial results and guarantee the progress of clinical trials,the risk management of subjects was discussed through two aspects separately in the article:the protection of subjects'rights and in‑terests and the subject management in quality control of early clinical trials.Combined with the new model of subject risk management in drug clinical trial quality control,the subject risk management strategy was proposed to further improve the risk management awareness of the subjects in the clinical trial process.

关 键 词：早期药物临床试验 风险控制 受试者权益保护 抗肿瘤药物 质量控制 

分 类 号：R969[医药卫生—药理学]