Countermeasure research on improving clinical trial ability of traditional Chinese medicine hospitals by strengthening digital information construction
通过加强数字信息化建设提升中医医院临床试验能力的对策研究

摘要

随着临床研究进入大数据时代，高质量研究对数据管理的信息化需求日益提升。中医医院在临床试验信息化建设方面相对滞后，成为制约中医药现代化的关键瓶颈。本文通过系统梳理临床试验机构能力评估标准，阐释临床试验电子信息化核心概念，结合政策需求分析国内外信息化管理现状，最终提出提升中医医院临床试验数字化能力的对策，具体包括：建立基于ICH-GCP和FDA指南的中医院信息化规范标准、构建包含9大功能模块的临床试验管理系统、引入人脸识别与区块链技术实现受试者智能招募与全程追溯、开发融合中医四诊信息的中医特色电子病历系统。预期可显著提升中医院临床试验数据质量与管理效率。

Abstract

With clinical research entering the era of big data, the demand for information-based data management in high-quality research is increasing. Traditional Chinese medicine (TCM) hospitals lag behind in the construction of clinical trial informationization, which has become a key bottleneck restricting the modernization of TCM. This article systematically reviews the assessment standards for the capabilities of clinical trial institutions, explains the core concepts of clinical trial electronic informationization, analyzes the current status of information management at home and abroad in combination with policy demands, and ultimately proposes countermeasures to enhance the digital capabilities of clinical trials in TCM hospitals. These include: establishing informationization norms and standards for TCM hospitals based on ICH-GCP and FDA guidelines, constructing a clinical trial management system with nine functional modules, introducing facial recognition and blockchain technology to achieve intelligent recruitment of subjects and full traceability, and developing a TCM characteristic electronic medical record system integrating the four diagnostic methods of TCM. It is expected to significantly improve the data quality and management efficiency of clinical trials in TCM hospitals.