The emulation of clinical trials with real-world data: development and application of target trial

VernacularTitle:利用现实世界数据仿真临床试验：目标试验的发展与应用
Author: Jiawei ZHOU ¹ ; Lihong HUANG ; Dongfang YOU ; Feng CHEN ; Yang ZHAO
Author Information

1. 南京医科大学公共卫生学院生物统计学系，南京　211166
Keywords: Target trial emulation; Observational study; Quality of evidence; Clinical trial
From: Chinese Journal of Epidemiology 2024;45(2):279-285
CountryChina
Language:Chinese
Abstract: Clinical trial is the gold standard for evaluating the efficacy and safety of interventions; however, it is limited by high costs and long time. Real-world data (RWD) can provide a robust data basis for comparative research, but the quality is uneven. This review introduces the target trial emulation, in which researchers, using RWD and following the design of clinical trials, define exposure and outcome in advance, set eligibility criteria, determine the time zero, estimate sample size, and plan statistical analysis, to enhance the quality of evidence for observational studies. This review preliminarily discusses the standard of evidence quality evaluation in target trial emulation. Then, the target trial emulation is shown through case interpretation.