Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs
- VernacularTitle: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
- Author:
Juan ZHAO
1
;
Li GONG
1
;
Jie SHEN
1
;
Huiyao YANG
1
;
Bin LIAO
1
Author Information
1. Phase Ⅰ Clinical Ward，Chongqing University Cancer Hospital，Chongqing 400030，China
- Publication Type:Journal Article
- Keywords:
full-time pharmacist;
early-phase clinical trial;
antineoplastic drugs;
role definition;
pharmaceutical care
- From:
China Pharmacy
2026;37(3):294-298
- CountryChina
- Language:Chinese
-
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.
