Keywords: Real World Evidence
Prospectively designed traditional clinical trials have been playing a major role to provide confirmatory evidence for efficacy/effectiveness and safety of FDA regulated medical products. Recently, with the release of FDA Draft Guidance of "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices", there is a growing interest in leveraging Real World Evidence (RWE), especially in the area of medical devices. However, there are many challenging issues on how to translate Real World Data (RWD), which are collected from a variety of different sources (e.g., Clinical Registry) outside of traditional clinical trials into Real World Evidence which can then been leveraged upon with confidence as being valid to provide a reasonable assurance for medical device effectiveness and safety. In this roundtable session, we will discuss some of the common issues from several statistical perspectives focusing on the importance of prospectively defined data collection plan to mitigate bias and to ensure the validity of statistical inference.