基于登记/注册研究的随机对照试验 Registry-Based Randomized Clinical Trials

Abstract

基于登记/注册研究的随机对照试验是一种利用现有的高质量登记/注册平台进行病例记录、数据收集、随机化应用以及随访的临床试验。本文简要介绍基于登记/注册研究的随机对照试验的基本概念、历史渊源、设计思路与传统随机对照试验的比较、适用场景、案例解读、统计方法及报告规范等内容，以期帮助临床研究者认识了解、掌握此类研究设计。 Abstract: A registry-based randomized controlled trial (RCT) is a clinical trial utilizing the existing high-quality registry platform for case records, data collection, randomized utilization, and follow-up. This article introduced the basic concept, historical origin, design ideas of registry-based RCT, comparison with traditional RCTs, applicable scenarios, cases analysis, statistical methods, report standards and so on.

Keywords

• 登记
• 随机对照试验
• 临床研究
• 真实世界数据
• registry
• randomized controlled trial
• clinical study
• real-world data