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GCP驻科药师在皮肤病专业药物临床试验管理中的实践路径与

效果评价
Δ

＊
王云龙 ，周立敏，章 华，李全超（南阳市第一人民医院药学部，河南 南阳 473010）

中图分类号 R95；R969.4 文献标志码 A 文章编号 1001-0408（2025）20-2507-05
DOI 10.6039/j.issn.1001-0408.2025.20.04

摘 要 目的 探索药物临床试验机构办公室驻科药师（下称“GCP驻科药师”）在皮肤病专业药物临床试验管理中的实践路径并
评价其效果。方法 对我院GCP驻科药师参与皮肤病专业药物临床试验的实践路径进行介绍；回顾性分析2021－2024年我院皮
肤病专业药物临床试验相关数据，对比皮肤病专业药物临床试验项目与其他专业项目的效率指标和质量指标。结果 我院GCP
驻科药师全程参与皮肤病专业药物临床试验的流程建设和优化，建立该专业药物临床试验专属质控体系，并优化该专业药物临床
试验受试者入组加速策略。GCP驻科药师工作开展后，2021－2023年我院皮肤病专业药物临床试验项目数的复合年均增长率为
69.56%。效率指标方面，皮肤病专业药物临床试验项目的立项等待时间为（12.31±4.99）d，显著短于其他专业项目的（19.68±
6.09）d（P＜0.05）。质量指标方面，皮肤病专业药物临床试验项目入组率为75.71%（50.00%，114.48%），显著高于其他专业项目的
51.00%（25.00%，174.17%）（P＜0.05）；首次质控问题条目数[（8.31±3.25）条 vs. （11.68±4.49）条]、方案偏离次数[5.5（2.0，11.0）次
vs. 11.0（5.5，17.5）次]均显著少于其他专业项目（P＜0.05）。结论 GCP 驻科药师显著提升了皮肤病专业药物临床试验的整体效
能，对确保药物临床试验可靠、真实，保障受试者权益、安全具有重要作用。
关键词 GCP驻科药师；药物临床试验；皮肤病专业；质量控制

Practice pathway and effectiveness evaluation of GCP resident pharmacists in the management of
dermatological drug clinical trials
WANG Yunlong，ZHOU Limin，ZHANG Hua，LI Quanchao（Dept. of Pharmacy， Nanyang First People’s
Hospital， Henan Nanyang 473010， China）

ABSTRACT OBJECTIVE To explore the practice pathway and evaluate the effectiveness of the resident pharmacists stationed in
the Drug Clinical Trial Institution Office （hereinafter referred to as the “GCP resident pharmacist”） in the management of
dermatological drug clinical trials. METHODS The practical approach of GCP resident pharmacists participating in dermatological
drug clinical trials at our hospital was introduced. A retrospective analysis was conducted on the data of dermatological drug clinical
trials from 2021 to 2024， comparing efficiency and quality indicators between dermatological clinical trials and those of other
specialties. RESULTS With the involvement of our hospital’s GCP resident pharmacists throughout, the process for dermatology
drug clinical trials was constructed and optimized， a dedicated quality control system was established， and the acceleration strategy
for subject enrollment was optimized. The number of dermatological drug clinical trials at our hospital showed a compound annual
growth rate of 69.56% from 2021 to 2023. In terms of efficiency indicators， the approval waiting time for dermatological drug
clinical trials was （12.31±4.99） days， which was significantly shorter than that of other specialties [（19.68±6.09） days， P＜0.05].
Regarding quality indicators， the enrollment rate for dermatological drug clinical trials was 75.71%（50.00%，114.48%）， which was
significantly higher than that of other specialties [51.00%（25.00%，174.17%）， P＜0.05]. The numbers of first quality control issues
[ （8.31±3.25）items vs. （11.68±4.49）items] and protocol deviations [5.5（2.0，11.0）times vs. 11.0（5.5，17.5）times] were significantly
lower than those of other specialties （P＜0.05）. CONCLUSIONS GCP resident pharmacists significantly enhance the overall
efficiency of dermatological drug clinical trials， playing a crucial role in ensuring the reliability and authenticity of drug clinical
trials， as well as safeguarding the rights and safety of trial subjects.
KEYWORDS GCP resident pharmacist； drug clinical trials； dermatological specialty； quality control

国家于 2019 年采取药物临床试验机构备案制管理 物临床试验机构备案管理信息平台显示的药物临床试
后，国内药物临床试验机构不断增加，截至2024年底，药 验备案机构有近 1 700 家 [1―2] 。药物临床试验机构数量

的增加，使申办者在项目调研和落地过程中有更多的选
Δ 基金项目 南阳市科技发展计划项目（No.23RKX137）
择，也加剧了药物临床试验机构之间的竞争。如何通过
＊第一作者 副主任药师。研究方向：医院药事管理。电话：0377-
63310455。E-mail：sjxk@163.com 高效服务加快药物临床试验的进度并确保临床试验过

中国药房 2025年第36卷第20期 China Pharmacy 2025 Vol. 36 No. 20 · 2507 ·