Maximizing the potential of real-world evidence: pre-, central to and post-regulatory approval

In this original editorial, Brett Beaulieu-Jones (Harvard Medical School, MA, USA) discusses the relevance of real-world evidence to the various stages of the regulatory drug approval process and how it measures up against data from randomized controlled trials. Brett Beaulieu-Jones is a Research Fellow within the Department of Biomedical Informatics at Harvard Medical School (MA, USA); in this position, Beaulieu-Jones is focused on expanding the use of machine learning-based methods to more precisely define phenotypes from large-scale biomedical data repositories — such as those contained in clinical records — to include large-scale data integration. Beaulieu-Jones has two primary concentrations: 1)...