临床试验中心药房信息化建设相关思考

Thinking of Informatization Construction for Clinical Trial Centralized Pharmacy

关键词:  临床试验  药物临床试验中心药房  信息化建设

Key words:  clinical trial  clinical trial centralized pharmacy  informatization construction

摘要:

目的 从浙江大学医学院附属第一医院的相关经验出发，探讨目前药物临床试验中心药房信息化建设的现状与挑战。方法 回顾临床试验药物管理及信息化的发展历程，结合笔者所在医院实践经验，从信息化系统的框架构建到具体操作细节等方面，介绍试验药物中心化管理方法，并对目前遇到的问题进行总结归纳并提出未来展望。结果 信息化建设对于临床试验中心药房管理具有重要作用，使其能够适应复杂的试验用药物管理需求，达到药物临床试验质量管理规范(Good Clinical Practice，GCP)和相关法律法规的高标准、严要求。但目前信息化系统的发展仍未完善，存在需要解决的问题。结论 各研究中心需要重视临床试验中心药房信息化建设，改进和完善试验药物中心化管理方法，引入新的技术与设备，这对于构建符合GCP及药物临床试验发展趋势的试验药物管理模式具有重要意义。

Abstract:

OBJECTIVE To explore the current status and challenges of informatization construction for clinical trial centralized pharmacy based on the relevant experience of The First Affiliated Hospital, Zhejiang University School of Medicine. METHODS Review the development of clinical trial drug management and informatization process, along with the management experience of the hospital where the author works, and then introduce the framework and specific operation details of the informatization system when conducting centralized management method, summarize the problems encountered at present and propose future prospects. RESULTS Informatization construction played a significant role in the management of central pharmacies in clinical trial, enabling them to adapt to the complex management needs of investigational products and meet the high standards and strict requirements of Good Clinical Practice(GCP) and related regulations. However, the development of the current information system was still not perfect, and there were problems that need to be solved. CONCLUSION Each hospital needs to pay attention to the informatization construction of the central pharmacy of the clinical trial, improve and perfect the centralized management method of the investigational products, and explore modern technologies and equipments, which are of immense importance for the construction of the clinical trial pharmacy management that conforms to the development trend of drug clinical trials and GCP.