The 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). Despite an increasing number of sources of high-quality real-world data (RWD), there remain many situations in which a data-based solution has important strategic and/or scientific limitations. What are the strategic and scientific imperatives for prospectively generated real-world evidence (RWE)?
Watch our on-demand webinar that explores the RWE/RWD landscape and the 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 real-world evidence.
