Keywords: Big data; Real world evidence; Regulatory decision-making
In this era of “Big Data”, there are many sources of real world healthcare data that could be leveraged in the clinical studies in the regulatory settings. While such large quantities of data reflect real world clinical practice and could potentially be used to reduce the cost of clinical trials, challenges arise concerning transforming the real world data into valid scientific evidence and using such evidence in the regulatory decision making. This presentation will share how real world evidence is used in medical device regulatory decision making and discuss the opportunities and challenges from statistical and regulatory perspectives.