早期抗肿瘤药物临床试验受试者风险管理<sup>★</sup>

doi:10.3969/j.issn.2095-1264.2023.04.09

首页 > 过刊浏览>2023年第4期 >455-460. DOI:10.3969/j.issn.2095-1264.2023.04.09

早期抗肿瘤药物临床试验受试者风险管理★
DOI:
                        10.3969/j.issn.2095-1264.2023.04.09
                    
作者:
                        
                        
                    
作者单位: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
作者简介:邓俊，女，硕士，主治医师，研究方向：临床肿瘤学。
通讯作者:李坤艳，女，博士，主任药师，研究方向：临床药理学
中图分类号:R969
基金项目:★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）。

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

Author:

Affiliation:

The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University/ Hunan Cancer Hospital, Changsha, 410006, Hunan, China

Fund Project:

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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。

Abstract:

In order to take the protection of subjects' rights and interests as the core, improve the quality of drug clinical 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 interests 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.