FDA’s Gottlieb Presents Approach to Real-World Evidence in Clinical Trials

Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday at the Bipartisan Policy Center conference, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.