公立医院药物临床试验管理的现状与优化策略
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作者:
作者单位:

1.江苏省省级机关医院药物临床试验机构办公室 ;2.伦理办公室,江苏 南京 210024

作者简介:

张婷婷(1981—),女,江苏南京人,副研究员,研究方向为临床试验质量管理。

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中图分类号:

R197.3

基金项目:


Current status and optimization strategies for the management of drug clinical trials in public hospitals
Author:
Affiliation:

1. Department of Clinical Trial Institutions ; 2. Ethics Office, Jiangsu Provincial Official Hospital, Nanjing 210024 , China

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    摘要:

    文章系统分析了公立医院药物临床试验管理的重要意义、现实困境及优化策略。公立医院作为开展药物临床试验的核心主体,在保障受试者权益、维护数据完整性与可追溯性、确保试验合规及覆盖受试群体广泛等方面发挥着关键作用。然而,当前管理实践中仍面临运行效率低下、专业人才短缺且流失严重、信息化水平滞后及质量控制体系不健全等多重挑战。为此,文章提出优化管理模式与流程、加强专业化人才队伍建设、推进信息化与数字化转型、完善质量控制体系以及拓展多元合作等策略,以全面提升药物临床试验管理的质量与效率,推动公立医院药物临床试验向更加科学、规范、高效的方向发展。

    Abstract:

    This article systematically examines the significance, practical challenges, and optimization strategies for drug clinical trial management in public hospitals. As the primary institutions conducting drug clinical trials, public hospitals play a critical role in safeguarding participants' rights, maintaining data integrity and traceability, ensuring trial compliance, and achieving broad coverage of the target population. However, current management practices still face multiple challenges, including operational inefficiency, shortages of specialized professionals with high attrition rates, lagging informatization levels, and inadequate quality control systems. To address these issues, the article proposes strategies to enhance the quality and efficiency of clinical trial management comprehensively. These include optimizing management models and processes, strengthening the development of specialized talent pools, advancing digital and informatization transformation, refining quality control systems, and expanding diversified collaborations. Such measures will promote clinical trials in public hospitals towards more scientific, standardized, and efficient practices.

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张婷婷,车顺通,黄健,周卫华.公立医院药物临床试验管理的现状与优化策略[J].南京医科大学学报(社会科学版),2026,(2):191~195

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  • 收稿日期:2025-09-26
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  • 在线发布日期: 2026-04-29
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