Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs

ZHAO Juan; GONG Li; SHEN Jie; YANG Huiyao; LIAO Bin

doi:10.6039/j.issn.1001-0408.2026.03.04

您当前的位置：

首页 >

文章列表页 >

Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs

更新时间：2026-02-11

- Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs
- ZHONGGUO YAOFANG Vol. 37, Issue 3, Pages: 294-298(2026)
- 作者机构：
  
  重庆大学附属肿瘤医院Ⅰ期病房，重庆　400030
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2026.03.04
  CLC： R95
- Received：21 July 2025，
  
  Revised：2025-12-12，
  
  Accepted：12 December 2025，
  
  Published：15 February 2026
- 稿件说明：
移动端阅览
赵娟,龚莉,沈杰,等.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 ^Δ[J].中国药房,2026,37(03):294-298.

ZHAO Juan,GONG Li,SHEN Jie,et al.Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs[J].ZHONGGUO YAOFANG,2026,37(03):294-298.
赵娟,龚莉,沈杰,等.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 ^Δ[J].中国药房,2026,37(03):294-298. DOI： 10.6039/j.issn.1001-0408.2026.03.04.

ZHAO Juan,GONG Li,SHEN Jie,et al.Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs[J].ZHONGGUO YAOFANG,2026,37(03):294-298. DOI： 10.6039/j.issn.1001-0408.2026.03.04.

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 clin

ical 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

Keywords

references

IQVIA . Global oncology trends 2025 [EB/OL ] . [ 2025-06-18 ] . https：//www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-oncology-trends-2025 https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-oncology-trends-2025 .

胡文娟，杜瑜，唐凌，等 . 早期临床试验期间抗肿瘤治疗药物安全性评估 [J ] . 中国新药杂志， 2024 ， 33 （ 20 ）： 2114 - 2118 .

国家药品监督管理局药品审评中心 . 以临床价值为导向的抗肿瘤药物临床研发指导原则 [EB/OL ] . [ 2025-06-18 ] . https：//www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=67c30813bd94792b5b2a9f9bd7121763 https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=67c30813bd94792b5b2a9f9bd7121763 .

国家药品监督管理局食品药品审核查验中心 . 药物Ⅰ期临床试验管理指导原则 [EB/OL ] .[ 2025-08-08 ] . https：//www.cfdi.org.cn/cfdi/resource/news/16424.html https://www.cfdi.org.cn/cfdi/resource/news/16424.html .

王肇聪，张峰，许芳，等 . 临床试验用抗肿瘤药物管理模式构建与探索 [J ] . 医药导报， 2024 ， 43 （ 7 ）： 1161 - 1164 .

国家药品监督管理局食品药品审核查验中心 . 药物临床试验机构监督检查要点及判定原则：试行 [EB/OL ] .[ 2025-06-18 ] . https：//www.cfdi.org.cn/cfdi/resource/news/15689.html https://www.cfdi.org.cn/cfdi/resource/news/15689.html .

张强，席红领，单爱莲 . 临床试验用药品的管理探讨 [J ] . 中国临床药理学杂志， 2025 ， 41 （ 2 ）： 260 - 263 .

马丽平，李语玲，王铁军，等 . 药师在临床试验药物管理过程中的风险防控与思考 [J ] . 中南药学， 2021 ， 19 （ 10 ）： 2217 - 2220 .

KELLY G . Science Saturday：pharmacists play key role in clinical research [EB/OL ] .[ 2025-06-18 ] . https：//newsnetwork.mayoclinic.org/discussion/science-saturday-pharma- cists-play-key-role-in-clinical-research https://newsnetwork.mayoclinic.org/discussion/science-saturday-pharma-cists-play-key-role-in-clinical-research .

FUJII H . Pharmacist intervention and identification of adverse events related to treatment efficacy in cancer chemotherapy to improve clinical outcomes [J ] . J Pharm Health Care Sci ， 2024 ， 10 （ 1 ）： 81 .

STAYNOVA R ， GAVAZOVA E ， KAFALOVA D . Clinical pharmacist-led interventions for improving breast cancer management：a scoping review [J ] . Curr Oncol ， 2024 ， 31 （ 8 ）： 4178 - 4191 .

赵伟杰，张彤群，刘婧，等 . 药师在药物临床试验中的作用概述 [J ] . 中国药师， 2016 ， 19 （ 7 ）： 1348 - 1350 .

杨莹，王玲 . 药物临床试验的质量管理探讨 [J ] . 中国药业， 2024 ， 33 （增刊1 ）： 264 - 266 .

龚莉，廖斌，沈杰，等 . 抗肿瘤药物Ⅰ期临床试验质量管理要点 [J ] . 肿瘤防治研究， 2025 ， 52 （ 5 ）： 347 - 354 .

赵秋玲，林美凤，陈娟，等 . 应用新型抗肿瘤药物肺癌患者的药学服务切入点探讨 [J ] . 中国医院药学杂志， 2022 ， 42 （ 20 ）： 2195 - 2197，2202 .

袁婷婷，余自成，杜静，等 . 药师在药物临床试验中的角色与定位 [J ] . 中南药学， 2021 ， 19 （ 3 ）： 553 - 556 .

American College of Clinical Pharmacy （ACCP） . Standards of practice for clinical pharmacists [J ] . J Am Coll Clin Pharm ， 2023 ， 38 （ 4 ）： 897 - 912 .

蒋雅楠，晁雨秋，鞠佳明，等 . 药学本科与研究生教育接轨路径的探索与思考 [J ] . 药学研究， 2025 ， 44 （ 8 ）： 814 - 818 .

文婷婷，王文波，董文彬，等 . 美国HOPA《临床试验药学服务最佳实践标准》解读 [J ] . 中国处方药， 2020 ， 18 （ 6 ）： 20 - 22 .

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Exploration of a new model for the construction of medical institution formulation platforms from the perspective of industry-university-research collaborative innovation theory

浙江地区医疗机构的创新药学服务实践

我院药师依托微信公众平台开展药学服务的实践与体会

基于“大药学”理念的我院药学学科建设思考与实践

我国与部分国家及地区零售药店监管与药学服务模式的对比分析

Related Author

LIN Kana

SHEN Anle

WANG Yejian

WANG Yanqiong

LI Hao

GUO Yanfang

WANG Youjun

SUN Xinyan

Related Institution

Clinical Research Center， Shanghai Children’s Medical Center， Shanghai Jiao Tong University School of Medicine

Dept. of Clinical Pharmacy， Shanghai Children’s Medical Center， Shanghai Jiao Tong University School of Medicine

Dept. of Pediatrics， Gongli Hospital of Shanghai Pudong New Area

⁰