Biometrical support and information infrastructure for the Priority Research Program "Age-related Macular Degeneration; biometrics, data management, and monitoring of the clinical study "MARAN - Surgical Management of Subfoveal Choroideal Membranes in AMD

优先研究计划“年龄相关性黄斑变性；生物识别、数据管理和临床研究监测”MARAN - AMD 黄斑中心凹下脉络膜的手术治疗的生物识别支持和信息基础设施

• 批准号: 5381840
• 负责人: Professor Dr. Ulrich Mansmann
• 金额: --
• 依托单位: Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie
• 依托单位国家: 德国
• 项目类别: Priority Programmes
• 财政年份: 2002
• 资助国家: 德国
• 起止时间: 2001-12-31 至 2006-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/5381840?language=en
• 关键词: Biometrical; support; information; infrastructure; Priority

This project aims at three goals: 1. The establishing of a cross-project database which collects the data in a standardized and anonymous way. The tasks of this database are: To establish a high-quality documentation of phenotypes, genetic and imaging information, to collect information useful for the planning of future clinical studies, to support future quality assurance activities in the field of AMD, and to codify the clinical experience of the priority research program in a way to be used by future researchers for activities like meta-analyses. It is intended to stimulated synergistic effects between the projects of the priority research program, to design cross-project research problems, and to improve the exchange of information between the individual projects. 2. The installing of a high-quality methodological support within the priority research program; to improve the modelling of pathological processes; to introduce model based merging of morphological data and findings in functional, biochemical and histological processes; to initiate the analysis of pooled data with respect to problems of prognosis, genetic epidemiology, and the correspondence between imaging and functional parameters; to support the transition of results in basic research to clinical concepts (Phase I, Phase II studies). 3. To ensure that the clinical study MARAN is conducted according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline for Good Clinical Practice (GCP). This goal consists in methodological and biometrical support, data management, and monitoring.

该项目旨在实现三个目标： 1. 建立跨项目数据库，以标准化和匿名的方式收集数据。该数据库的任务是：建立表型、遗传和影像信息的高质量文档，收集对规划未来临床研究有用的信息，支持AMD领域未来的质量保证活动，并以供未来研究人员用于荟萃分析等活动的方式整理优先研究项目的临床经验。其目的是激发优先研究计划项目之间的协同效应，设计跨项目研究问题，并改善各个项目之间的信息交流。 2. 在优先研究计划中建立高质量的方法论支持；改进病理过程的建模；引入基于模型的形态学数据和功能、生化和组织学过程发现的合并；启动对预后、遗传流行病学以及成像和功能参数之间的对应关系等问题的汇总数据的分析；支持基础研究成果向临床概念的转变（第一期、第二期研究）。 3. 确保临床研究MARAN按照人用药品注册技术要求国际协调会议（ICH）良好临床实践（GCP）指南进行。这一目标包括方法和生物识别支持、数据管理和监控。