1. VA New England Healthcare System, Boston University School of Medicine, Boston, MA, USA; 2. Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA, USA
During the last decade, there has been a mounting tension between how physicians interpret scientific evidence derived from randomised controlled trials (RCTs) and the rapidly expanding sources of digitised data that comprise observational studies, registries and, more recently, machine learning and artificial intelligence that are now commonly referred to as real-world data (RWD) or real-world evidence (RWE)1,2,3. Many regard such non-randomised observational analyses of large electronic patient databases as an alternative to RCTs and as a valid and worthy source of RWE. Apart from the prevalent view that traditional, large, multicentre RCTs have become too complex, costly, and selective, ...