中国药房2026，Vol.37Issue(3)：294-298,5.DOI:10.6039/j.issn.1001-0408.2026.03.04
专职临床试验药师在抗肿瘤药物早期临床试验管理中的角色定位研究
Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs
摘要
Abstract
OBJECTIVE To clarify the roles and functions of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs,and to provide theoretical and practical support for their transformation from traditional drug managers to multi-dimensional roles in clinical research.METHODS Combined with relevant regulations such as the Good Clinical Practice(GCP)(2020 Edition),and based on the clinical practice experience of the Phase Ⅰ Clinical Ward in our hospital,this study systematically sorted out full-time pharmacists'roles and functions in early-phase clinical trials of antineoplastic drugs,and explored the core challenges and optimization pathways for role transformation and capacity-building of domestic full-time clinical trial pharmacists.RESULTS&CONCLUSIONS Full-time pharmacists assumed multiple roles in early-phase clinical trials of antineoplastic drugs,including providing pharmaceutical support for protocol design,implementing whole-process standardized management of clinical trial drugs,ensuring medication safety for clinical trial subjects/participants,conducting quality control throughout the clinical trial process,and serving as a bridge for interdisciplinary collaboration and communication.Currently,there are challenges in this field in China,such as unclear roles,an imperfect capacity building system,and insufficient regulatory support.This paper proposes that by establishing a standardized role framework,clarifying the core responsibilities and authorities of full-time pharmacists,and leveraging cutting-edge technologies to provide comprehensive support for their roles,so as to fully harness their pharmaceutical expertise and contribute to the standardization and efficiency of the antineoplastic new drug development process.关键词
专职临床试验药师/早期临床试验/抗肿瘤药物/角色定位/药学服务Key words
full-time pharmacist/early-phase clinical trial/antineoplastic drugs/role definition/pharmaceutical care分类
医药卫生引用本文复制引用
赵娟,龚莉,沈杰,杨辉尧,廖斌..专职临床试验药师在抗肿瘤药物早期临床试验管理中的角色定位研究[J].中国药房,2026,37(3):294-298,5.基金项目
重庆市沙坪坝区技术创新项目(No.2025098) （No.2025098）
