基于登记/注册研究的随机对照试验

doi:10.3969/j.issn.1673-5765.2022.10.018

摘要/Abstract

摘要： 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。

关键词: 登记; 随机对照试验; 临床研究; 真实世界数据

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.

Key words: Registry; Randomized controlled trial; Clinical study; Real-world data

周齐, 杨凯璇, 姜英玉, 谷鸿秋. 基于登记/注册研究的随机对照试验[J]. 中国卒中杂志, 2022, 17(10): 1145-1151.

ZHOU Qi, YANG Kaixuan, JIANG Yingyu, GU Hongqiu. Registry-Based Randomized Clinical Trials[J]. Chinese Journal of Stroke, 2022, 17(10): 1145-1151.

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