关键词: Adaptive Clinical-Trial Biomarker stratification CDMS Clinical Data Containerization Interoperability Machin-Learning Algorithms Microservices-based Architecture Platform Trials eCRF Adaptive Clinical-Trial Biomarker stratification CDMS Clinical Data Containerization Interoperability Machin-Learning Algorithms Microservices-based Architecture Platform Trials eCRF

来  源:   DOI:10.3233/SHTI220458

Abstract:
Information systems used by platform trials should handle changes that are not predefined. Unfortunately, the technical architecture of most existing clinical data management systems (CDMS) do not support changes to be incorporated into an ongoing trial. Adaptive clinical trials need advanced architectural solutions setup to enable biomarker stratification and enrichment strategy necessary for the adaptive clinical trial operation. This short paper presents the microservices-based architecture solution that is used to run and support the adaptive RECORDS-Trial.
摘要:
平台试验使用的信息系统应处理未预定义的更改。不幸的是,大多数现有临床数据管理系统(CDMS)的技术架构不支持将变更纳入正在进行的试验.适应性临床试验需要先进的架构解决方案设置,以实现适应性临床试验操作所需的生物标志物分层和富集策略。这篇简短的论文介绍了基于微服务的架构解决方案,该解决方案用于运行和支持自适应RECORDS-Trial。
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