现实世界研究生态圈的构建与发展

Construction and development of the ecosystem for real-world study

摘要: 现实世界证据（real-world evidence，RWE）由现实世界数据（real-world data，RWD）产生，经现实世界研究（real-world study，RWS）转化而来。科学的RWE可为决策提供参考依据，其产生有赖于系统性地构建和发展良性生态圈。本文梳理了RWD、RWS在产生RWE中的角色及转化机制，试图探讨构建现实世界研究良性生态系统的必要性及构成要素，并简要展望生态圈的发展趋势、机遇及挑战。

Abstract: Real-world evidence (RWE) is generated via real-world study(RWS) based on real-world data (RWD). Reliable RWE is helpful for decision-making, which relies on a virtuous operating ecosystem. This study is aimed to propose the structure of RWS eco-system and to explore the virtuous mechanism for generating scientific evidence, as well as to discuss its future development.