Peek Behind the Paper: Navigating the maze of regulatory and health technology assessment agency real-world evidence frameworks

Regulatory and health technology assessment (HTA) agencies are rapidly publishing guidance to accommodate the increasing use of real-world data (RWD) and real-world evidence (RWE) in assessments, particularly for comparative effectiveness. This has led to an abundance of diverse guidance documents globally, creating complexity for manufacturers and researchers as they navigate the evolving RWD/RWE terminology and guidelines. Here we speak with Grammati Sarri (Cytel, Inc.) and Luis G Hernandez (Takeda) about their latest research article, “The maze of real-world evidence frameworks: from a desert to a jungle! An environmental scan and comparison across regulatory and health technology assessment agencies”, published in...