Duke-Margolis white paper on improving patient subgroup representation with real-world data

The Duke-Margolis Center for Health Policy has issued a cluster of three new white papers concerning real-world evidence (RWE). One of the series, Improving Patient Subgroup Representation with Real-World Data: Real World Efficacy and Patient Subgroups, addresses the opportunities for and challenges to using real-world data (RWD) to improve patient subgroup representation. In this Editorial, we summarize the key takeaways. Background Subsets of patients with specific clinical or demographic characteristics have traditionally been excluded from, or otherwise unengaged in, gold standard randomized controlled trials (RCTs). This under-representation of some subgroups has several highly significant consequences; it: Limits the generalizability of...