M. Burcu

Use of real-world evidence in the U.S. Food and Drug Administration and the European Medicines Agency approvals of oncology products supported by single-arm trials (2022-2025)

Abstract Introduction Regulatory interest in real-world evidence (RWE) to supplement single-arm trials (SATs) in oncology has increased, yet how the Food and Drug Administration (FDA) and European Medicines Agency (EMA) evaluate such evidence remains incompletely understood. Objective To comprehensively evaluate recent...