The special consideration for using the real-world data as external control in clinical evaluation

VernacularTitle:真实世界数据作为外部对照用于药械临床评价的特殊考虑
Author: Yuning WANG ¹ ; Minghong YAO ; Yan REN ; Jiayue XU ; Yulong JIA ; Kai LIN ; Yaohua LI ; Chunmin WEI ; Xin SUN
Author Information

1. 四川大学华西医院中国循证医学中心，成都　610041
Keywords: Clinical trial; Real world data; External control; Real world evidence
From: Chinese Journal of Epidemiology 2023;44(2):335-340
CountryChina
Language:Chinese
Abstract: Randomized controlled trials (RCT) have long been considered the gold standard for assessing clinical efficacy. However, RCT are inappropriate for some diseases due to related ethical issues and costs, such as rare diseases that are seriously life-threatening but without adequate treatment. Using real world data (RWD) as external control for RCT could make recruitment less complicated and reduce time and cost. This paper introduces common application scenarios, data sources, study design, basic principles, and statistical methods of RWD as an external control based on the latest guidelines related to RWD and combined with our team's previous research experience. This study could provide references for scholars and sponsors who want to conduct RWD research.