Fraccaro P, Giacomini Mauro
Dept. of communication, University of Genoa.
Stud Health Technol Inform. 2012;180:554-8.
Clinical Trials (CTs) play an increasingly important role in modern medicine. Often these types of studies, especially in the final phases, require collaboration between several hospitals, laboratories and institutions in different places or countries. The solution proposed is a template which exploits the principles of Networked Clinical Research and the strengths of Clinical Data Management Systems (CDMSs) commonly used (Electronic Data Capture (EDC), Electronic Medical Record (EMR) and Electronic Health Record (EHR). Therefore, the basic structure is a highly normalized and standardized database which is managed by a web platform and, only by recording the required information and developing web pages starting from predefined templates, it is possible to carry out new projects. The result is a hybrid CDMS which preserves the flexibility and user autonomy of EDC systems; and contemporarily, permits the creation of patients cohorts, as in EMR and EHR systems, in which to realize simultaneously different multicentric CTs in several medical fields.
临床试验(CTs)在现代医学中发挥着越来越重要的作用。通常这类研究,尤其是在最后阶段,需要不同地点或国家的多家医院、实验室和机构之间进行合作。所提出的解决方案是一个模板,它利用了网络临床研究的原则以及常用临床数据管理系统(CDMSs)(电子数据采集(EDC)、电子病历(EMR)和电子健康记录(EHR))的优势。因此,基本结构是一个由网络平台管理的高度规范化和标准化的数据库,并且只需记录所需信息并从预定义模板开始开发网页,就可以开展新项目。结果是一个混合CDMS,它保留了EDC系统的灵活性和用户自主性;同时,像EMR和EHR系统一样,允许创建患者队列,以便在多个医学领域同时开展不同的多中心CTs。