Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.
Med Sci Monit. 2021 Jun 14;27:e933554. doi: 10.12659/MSM.933554.
Patient registries include data on patient diagnosis, demographics, treatment, and outcomes and are now fundamental to the provision of successful global health systems. Patient registries include mainly local, regional, and national patient data on general or specific patient groups. Global registries currently exist mainly for rare diseases. Some of the most studied registries include the national Surveillance, Epidemiology, and End Results (SEER) program and the hospital-based Medical Information Mart for Intensive Care (MIMIC-III) dataset. The limitations of registry databases have included lack of feedback from clinical studies to the clinical center, the lack of patient involvement, and limited findings on patient-reported outcomes (PROs). In September 2020, the European Medicines Agency (EMA) published its draft guidelines on registry-based clinical studies. Guidelines for the development and analysis of registry data will improve the quality and registry-based studies and increase the role of registry data to support clinical trials. This Editorial aims to present the current status of registries and population databases in clinical research and practice.
患者登记处包括患者诊断、人口统计学、治疗和结果的数据,现在是成功的全球卫生系统提供的基础。患者登记处主要包括一般或特定患者群体的本地、区域和国家患者数据。全球登记处目前主要针对罕见病。一些研究最多的登记处包括国家监测、流行病学和最终结果 (SEER) 计划和基于医院的重症监护医疗信息集市 (MIMIC-III) 数据集。登记处数据库的局限性包括缺乏临床研究向临床中心的反馈、缺乏患者参与以及患者报告结果 (PRO) 的发现有限。2020 年 9 月,欧洲药品管理局 (EMA) 发布了基于登记的临床研究草案指南。登记数据的开发和分析指南将提高质量和基于登记的研究,并增加登记数据在支持临床试验中的作用。本社论旨在介绍登记处和人群数据库在临床研究和实践中的现状。