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疫苗临床试验进度管理探讨

  • 李广富 ,
  • 吕蕾莉
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  • 甘肃农业大学管理学院, 兰州 730070

网络出版日期: 2025-08-16

Discussion on schedule management of vaccine clinical trial

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  • College of Management, Gansu Agricultural University, Lanzhou 730070, China

Online published: 2025-08-16

摘要

有效的临床试验进度管理可以提高疫苗临床试验效率、节约成本。通过考察分析,此文识别了临床试验进度管理面临的诸多挑战和5个关键影响因素:科学的试验设计、合理的资源分配、有效的受试者管理、准确的数据管理以及严格的监管合规,提出了相应的进度管理策略,包括详尽的项目计划、定期的进度监控与及时调整、资源配置优化、沟通与协调机制的优化,以及利用先进技术以增强数据管理和透明度,旨在为疫苗临床试验管理提供理论依据与策略工具,指引研发团队优化临床试验的整体管理。

本文引用格式

李广富 , 吕蕾莉 . 疫苗临床试验进度管理探讨[J]. 国际生物制品学杂志, 2024 , 47(6) : 384 -389 . DOI: 10.3760/cma.j.cn311962-20240613-00042

Abstract

Effective clinical trial schedule management can improve the efficiency of vaccine clinical trials and save costs. Through investigation and analysis, this paper identifies many challenges and five key influencing factors of clinical trial schedule management: scientifical trial design, reasonable resource allocation, effective subject management, accurate data management and strict regulatory compliance, and puts forward corresponding schedule management strategies, including detailed project plan, regular schedule monitoring and timely adjustment, optimal resource allocation, optimization of communication and coordination mechanism, and use of advanced technology to enhance data management and transparency, aiming at providing theoretical basis and strategic tools for vaccine clinical trial management and guiding research and development teams to optimize the overall management of clinical trials.
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