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-中国药房

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

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篇名：	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
TITLE：	Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs
摘要：	目的明确专职临床试验药师在抗肿瘤药物早期临床试验管理中的核心角色定位与职能，为其从传统药品管理者向临床研究多维度角色转型提供理论依据与实践支撑。方法结合《药物临床试验质量管理规范（2020版）》等法律法规，基于本院Ⅰ期病房临床实践经验，系统梳理专职临床试验药师在抗肿瘤药物早期临床试验中的核心角色与职能，并探讨国内专职临床试验药师在角色转型与能力培养中的核心挑战与优化路径。结果与结论专职临床试验药师在抗肿瘤药物早期临床试验中承担多元角色，其核心职能包括在方案设计中提供药学专业支持、对临床试验用药品进行全流程规范化管理、为临床试验受试者/参与者提供用药安全保障、对临床试验全程进行质量控制及作为跨学科协作沟通桥梁。当前国内该领域存在专职临床试验药师角色定位不清晰、能力培养体系不完善、法规支撑不足等挑战。笔者提出可通过构建标准化角色体系，明确专职临床试验药师的核心权责，利用前沿技术为专职临床试验药师角色的发挥提供全方位支撑等措施，充分发挥其药学专业优势，助力抗肿瘤新药研发流程的规范化与高效化。
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.
期刊：	2026年第37卷第03期
作者：	赵娟；龚莉；沈杰；杨辉尧；廖斌
AUTHORS：	ZHAO Juan，GONG Li，SHEN Jie，YANG Huiyao，LIAO Bin
关键字：	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
KEYWORDS：	full-time pharmacist； early-phase clinical trial； antineoplastic drugs； role definition； pharmaceutical care
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