The “Coming of Age” of Real‐World Evidence in Drug Development and Regulation

This is the authors' abstract. We don't add key points for this paper.

Real world evidence (RWE) has the potential to inform drug discovery, development, and regulatory decision making. The emergence and availability of large population-based datasets around the globe have stoked enthusiasm in the research community. However, much work remains to refine research methodologies, evolve the science, and define the place of RWE as a complementary source of evidence to randomized controlled trials.