抗肿瘤药物临床试验中心药房信息化管理模式的建立与应用探讨  

Establishment and application of information management model for central pharmacy of anti-tumor clinical trial

作　　者：唐琪 谭英红 龚倩[1] TANG Qi;TAN Yinghong;GONG Qian(Department of National Drug Clinical Trial Institution,Hunan Cancer Hospital,Changsha,410013,Hunan,China)

机构地区：[1]湖南省肿瘤医院国家药物临床试验机构,湖南长沙410013

出　　处：《肿瘤药学》2024年第6期662-665,共4页Anti-Tumor Pharmacy

基　　金：湖南省自然科学基金项目(2021JJ80008)。

摘　　要：药物临床试验是新药研发过程中的一个重要阶段,其结果是药品注册上市的主要依据。临床试验药品是整个药物临床试验的核心,临床试验药物的规范管理是保障受试者生命安全和药物临床试验质量的关键。本文就当前传统人工化管理模式的弊端进行分析,并结合本院在药物信息化管理模式建立和应用过程中的经验,探讨试验药物规范化管理模式,以期提高临床试验药物管理水平,确保试验项目安全、有序、顺利地开展,并为药物信息化管理模式的广泛应用提供参考,探索新形势下临床试验机构高质量管理的实践思路。Drug clinical trial is an important stage in the process of new drug development,and the results of trials become the main basis for drug registration and marketing.Clinical trial drugs are the core of the whole drug clinical trial,and the standardized management of clinical trial drugs is the key to ensure the safety of subjects and the quality of clinical trials.This article analyzes the drawbacks of the current traditional artificial management mode,and combines the experience of the hospital in the establishment and application of drug information management mode to explore the standardized manage‐ment mode of investigational drugs,in order to improve the level of clinical trial drug management,ensure the safe,orderly,and smooth implementation of trial projects,and provide reference for the wide application of drug information management mode,and explore practical ideas for high-quality management of clinical trial institutions under new circumstances.

关 键 词：抗肿瘤药物 临床试验 临床试验药品 中心药房 信息化 

分 类 号：R730.5[医药卫生—肿瘤] R95[医药卫生—临床医学]