实效性临床试验：真实世界研究的随机化试验 Pragmatic Clinical Trials: A Randomized Trial in Real-World Studies

Abstract

实效性临床试验（pragmatic clinical trials，PCT）作为真实世界研究的重要构成，在临床研究设计中越来越受到关注和重视。然而，目前对PCT的理解和应用仍存在的一些误区。因此，本文首先从PCT的概念、研究策划与设计、研究目的、常见的设计类型和核心特征等方面进行阐述，使读者全面和正确地认识PCT。其次，本文详述了PCT的使用范围、基本的统计分析原则与各类型试验设计的分析要求。最后，本文明确了此类研究的报告规范。 Abstract: Pragmatic clinical trials (PCT), as a important component of real-world research, attracted more and more attention in clinical study design. However, there exists some confusions in understanding and application of PCT. Therefore, this article provided technical specifications of PCT in terms of the concept, study planning and design, purpose, design types and core features, to make readers have a comprehensive and correct understanding of PCT; in addition, the application scope, basic statistical analysis principles, analysis requirements for various types of study design, and the report standards of PCT were also elaborated.

Keywords

• 实效性临床试验
• 真实世界研究
• 临床试验
• 研究设计
• pragmatic clinical trial
• real-world study
• clinical trial
• study design