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Ⅰ期临床研究受试者招募系统的建设实践与探索

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目的 根据目前国内外临床试验招募困难导致临床试验开展进度缓慢的情况,结合国内影响受试者招募的主要因素,中山大学孙逸仙纪念医院Ⅰ期临床研究中心建设了逸仙临床研究招募平台信息化系统改善招募困难问题。该招募平台建立了Ⅰ期临床试验招募规范化管理体系和受试者数据库,为患者提供了药物临床试验搜索、试验报名模块,力图解决患者寻找药物临床试验难的问题。方法 系统基于现有的人工智能推荐算法,针对药物临床试验领域的特点,开发含有试验信息发布、会员注册、报名管理、病例库管理等功能。基于自研匹配算法,配合elasticsearch搜索引擎,能更快速匹配试验项目,提升患者招募效率;系统使用PHP设计语言、javascript设计语言、thinkphp、vue框架技术、MySQL数据库技术及MVP设计模式,实现了相关功能,并针对平台功能、性能进行了测试。结果 通过建立临床研究招募平台,研究者和患者可以即时获取临床试验招募信息。用户可以通过系统筛选功能,使用分类、固定字段或自定义字段来精确搜索临床试验信息,并直接在线报名参与试验。结论 通过招募信息平台的建设,改善了 Ⅰ期临床试验受试者招募困难的情况,有效地提高了 Ⅰ期临床试验的受试者招募效率和质量,加快了创新药物研发进度。
Practice and Exploration of the Construction of Subject Recruitment System in Phase Ⅰ Clinical Trial
OBJECTIVE According to the current situation of slow progress of clinical trial recruitment caused by domestic and foreign clinical trial recruitment difficulties,combined with the main factors affecting the recruitment of subjects in China,the Phase Ⅰclinical Research Center of Sun Yat-sen Memorial Hospital of Sun Yat-sen University built an information system for Yixian clinical research recruitment platform to improve the recruitment difficulties.The recruitment platform has established a standardized management system for phase Ⅰ clinical trial recruitment and a database of subjects,and provided the modules of drug clinical trial search and trial registration for patients,trying to solve the problem of difficult for patients to find drug clinical trials.METHODS Based on the existing artificial intelligence recommendation algorithm,the system was specially designed and developed for drug clinical trial subject recruitment according to the characteristics of drug clinical trial field,including trial information release,member registration,registration management,case database management and other functions.The system was based on self-developed matching algorithm and elasticsearch search engine,so that users could match suitable trial projects more quickly and improve patient recruitment efficiency.The system used PHP design language,javascript design language,thinkphp,vue framework technology,MySQL database technology and MVP design mode to realize the relevant functions of this platform,and test the platform functions and performance.RESULT At present,the Phase Ⅰ clinical research Center of the hospital had realized the instant release of clinical trial start-up recruitment information through the construction of clinical research recruitment platform.Researchers and patients could log into the system to employ systematic classification,fixed fields or personalized fields to achieve advanced screening of clinical trial information and retrieve accurate clinical trial information results.And through individual registration to achieve one-click registration clinical trials and other functions.CONCLUSION Through the construction of the recruitment information platform,the common recruitment difficulties of phase Ⅰ clinical trials are improved,the recruitment efficiency and quality of phase Ⅰ clinical trials were effectively improved,and the progress of innovative drug development is accelerated.

phase Ⅰ clinical trialsubject recruitmentrecruitment screeningrecruitment platform information systemartificial intelligence

吕晓枝、叶穗雯、伍俊妍、姚和瑞、张楠、毕晓莹、陈珺仪

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中山大学孙逸仙纪念医院Ⅰ期临床研究中心,广东广州 521000

Ⅰ期临床试验 受试者招募 招募筛选 招募平台信息化系统 人工智能

2024

今日药学
广东省药学会 中国药学会

今日药学

影响因子:0.413
ISSN:1674-229X
年,卷(期):2024.34(5)