数智化质控系统在药物临床试验中的设计探索  

Application and Exploration of Digital Intelligent Quality Control in Drug Clinical Trials

作　　者：卢慧勤[1] 刘祖玫 陈燕[1] 连万民[2] 余秋钿 LU Huiqin;LIU Zumei;CHEN Yan;LIAN Wanmin;YU Qiutian(Guangdong Second Provincial General Hospital,Clinical Research Department,Guangzhou,Guangdong 510317,China;Guangdong Second Provincial General Hospital,Information Technology Department,Guangzhou,Guangdong 510317,China)

机构地区：[1]广东省第二人民医院临床研究部,广东广州510317 [2]广东省第二人民医院信息科,广东广州510317

出　　处：《今日药学》2025年第2期127-131,共5页Pharmacy Today

基　　金：医院药学高质量发展研究项目(NIHAYS2312);广东省医学科学技术研究基金项目(A2022095)。

摘　　要：目的探索数智化质控在药物临床试验中的应用设计思路,以提升药物临床试验的质量和效率。方法根据广东省某医院过往的远程监察稽查系统使用经验,针对药物临床试验质控特点,分析了数智化质控框架在药物临床试验全流程中的相关需求,总结了数据框架及功能模块需要纳入的设计考量,并归纳了系统性能及安全维度的评价指标,设计了集成人工智能、大数据分析和云计算等技术的的数智化质控框架。结果数智化质控系统可显著提高临床试验的数据准确性和完整性,提升药物临床试验效率,增强对临床试验的实时监控能力,确保试验的合规性和安全性。此外,该框架可优化资源分配,缩短试验周期,降低整体成本。结论数智化为药物临床试验的质控提供了新的视角和方法论,对推动生物医药产业的数智化转型具有重要意义。OBJECTIVE To explore the application and design of digital intelligent quality control in drug clinical trials to improve the quality and efficiency.METHODS Based on the past experience with the remote monitoring and auditing system in a certain hospital in Guangdong province and the characteristics of quality control in drug clinical trials,the relevant needs of the digital intelligent quality control system that covers the entire drug clinical trial process were analyzed.The needs of the data framework and functional modules were summarized.The dimensions to evaluate system performance and security features were also proposed for the digital intelligent quality control system.A digital intelligent quality control system that integrates artificial intelligence,big data analysis,cloud computing technologies was designed.RESULTS The digital intelligent quality control system could significantly improve the accuracy and completeness of clinical trial data,improve the efficiency of drug clinical trials,enhance real-time monitoring capabilities,and ensure the compliance and safety of trials.In addition,this framework could also optimize resource allocation,shorten trial cycles,and reduce overall costs.CONCLUSION Digital intelligence provides new perspectives and methodologies for quality control in drug clinical trials and is significant or promoting the digital transformation of the biopharmaceutical industry.

关 键 词：数智化质控 临床试验 人工智能 大数据分析 云计算 

分 类 号：R969[医药卫生—药理学]