The Strategic And Scientific Imperative For Prospectively Generated Real-World Evidence

Data characterizing the real-world clinical, economic, and humanistic impact of innovative medical products are increasingly used across the broad spectrum of clinical and commercial development to support both regulatory approval and market access (with the former being a relatively new phenomenon since implementation of the 21st Century Cures Act).  Although there are an increasing number of sources of high-quality RWD, there remain many situations in which a data-based solution has important strategic and/or scientific limitations.  This webinar will explore the RWE/RWD landscape and focus on those situations in which a prospective observational study or registry presents a more optimal solution, while also focusing on the unique operational factors that must be accommodated to maximize time- and cost-efficiency in the de novo generation of RWE.