With the FDA’s introduction of new guidelines surrounding the use of real-world evidence (RWE) in medical device regulatory decisions, FDA Commissioner Scott Gottlieb advances the argument for the utility of RWE. In fact, the FDA is currently considering the role of RWE in evaluating pharmaceutical treatments. Despite much debate over what part RWE should play in regulatory approval and payer coverage decisions, many of us are left asking two fundamental questions: 1) Why do we need RWE?; and 2) If RWE is needed, how can we use it?
That is the opening paragraph of my article in Drug Discovery and Development last week. If you want to know the answers to these two questions, do read the whole thing.