国家科技部中国科技论文统计源期刊   中国科技核心期刊   WHO西太平洋地区医学索引(WPRIM)收录期刊   湖北优秀期刊
《药物流行病学杂志》官方网站与投审稿系统变更通知<点击查看详情>
病例注册登记的行动计划
Initiative for Patient Registries
  
DOI:
中文关键词:  注册登记研究  病例注册登记
英文关键词:Registry study  Patient registry
基金项目:
作者单位
裴正存 詹思延 ①北京大学公共卫生学院流行病与卫生统计学系(北京100191) 
摘要点击次数: 1547
全文下载次数: 1103
中文摘要:
      摘 要注册登记研究越来越多的应用于评估某一特定疾病、状况或暴露人群的特定结局。疾病注册登记和产品注册登记为常见的注册登记研究类型,两者的研究人群常常存在重叠,容易造成混淆。因此,欧洲药品管理局提出了“病例注册登记”的概念,并发布了开展病例注册登记的行动计划。该计划从患者人群入手,促进使用已有的病例注册登记,促进建立和使用新的注册登记,旨在获取可靠的数据信息并引导监管决策。了解设计和策划病例注册登记以及如何开展预试验,对开展类似的病例注册登记研究有一定的指导意义。本文概述了病例注册登记的行动计划,包括其背景、概念,以及可用的方法。
英文摘要:
      ABSTRACTRegistry study is suitable for evaluating outcomes of specific disease, health condition and exposure experience. Disease registry and product registry are two common types of registry study, there are always some overlaps between these two types with regard to study population, which may lead to misunderstandings. Thus, the European Medicines Agency made an emphasis on patient registry, and released an initiative for patient registry. The initiative focuses on patient population, encourages to explore existing registries, and promotes to establish new registries, the ultimate purpose is to obtain reliable data for better decision making. The design and planning, including a pilot phase, are essential for conducting patient registries. The background, definition, as well as alternative methods are discussed in this article.
查看全文  查看/发表评论  下载PDF阅读器
关闭