真实世界证据与随机对照试验证据比较研究

A comparative study of real-world evidence and randomized controlled trial evidence

大样本双盲的随机对照试验(RCT)结果历来代表循证医学临床证据的最高等级,但它无法解决所有的临床研究问题,因此基于真实世界研究(RWS)视角下的真实世界证据(RWE)得到了迅速发展。本文通过对比生成真实世界证据与随机对照试验证据在数据来源、内外部有效性、证据等级、应用范围、试验设计、实施要素、实施成本中的差异,旨在为真实世界证据的进一步应用发展提供参考。

Results from large-sample double-blind randomized controlled trial(RCT)have always represented the highest level of evidence-based medicine clinical evidence,but it cannot solve all the clinical research problems,thus real-world evidence(RWE)based on the perspective of real-world research(RWS)has developed rapidly.This paper aims to provide reference for the further application and development of RWE by comparing the differences between RWE and randomized controlled trial evidence in data source,internal and external effectiveness,evidence level,application scope,experiment design,implementation elements and implementation cost.