The US Food and Drug Administration's Real-World Evidence Framework: A Commitment for Engagement and Transparency on Real-World Evidence

摘要

In December 2018, the US Food and Drug Administration (FDA) published a framework for its program to explore the use of real-world evidence to help support new indications for drugs that are already approved or to help support or satisfy postapproval study requirements. The framework reflects a larger initiative to explore and pilot the utility of a variety of evidence types and technological innovations that may enhance and accelerate drug development.