Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016–2024
Clinical Trials: Journal of the Society for Clinical Trials
Published online on February 05, 2026
Abstract
Clinical Trials, Ahead of Print.
Background/Aims:There is growing interest in leveraging real-world data, such as electronic health records, administrative claims data, and patient registries, to generate real-world evidence studies that support the U.S. Food and Drug Administration’s ...
Background/Aims:There is growing interest in leveraging real-world data, such as electronic health records, administrative claims data, and patient registries, to generate real-world evidence studies that support the U.S. Food and Drug Administration’s ...