Leveraging Real-World Evidence Derived from Patient Registries for Premarket Medical Device Regulatory Decision-Making

Abstract

ABSTRACTIn this era of “Big Data,” there are many sources of real-world healthcare data that could be leveraged in clinical research in the regulatory environment. While such large quantities of data reflect real-world clinical practice and may potentially be used to reduce the cost or time of conducting clinical research, challenges arise concerning using real-world evidence derived from real-world data to inform or support premarket regulatory decision-making for medical devices. This article discusses such opportunities and challenges from statistical and regulatory perspectives with an emphasis on the use of real-world evidence derived from high-quality national and international patient registries.