Comparison of policies and guidelines regarding using of real world data/real word evidence

VernacularTitle: 真实世界数据/真实世界证据应用的政策法规及指导原则的比较研究
Author: Minhui WANG ¹
Author Information

1. Yijishan Hospital of Wannan Medical College
Publication Type:Journal Article
Keywords: Guideline; Policy; Real world data; Real world evidence; Real world study
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2020;25(8):878-889
CountryChina
Language:Chinese
Abstract: China and foreign regulators have conducted multiple discussions on how to use Real World Data (RWD) and Real World Evidence (RWE), also published relevant guidelines and framework files. The development and promotion of RWD/RWE application in China is relatively late, and there is a gap of systems and conditions between China and developed countries. This article aims to learn from advantage experiences of other countries and provide some referential ideas for exploring a strategy of RWD/RWE applications suitable for China by analyzing and comparing the current RWD/RWE application-related policies and guidelines in different regions.