Background
Data related to patient health status and/or the delivery of health care routinely collected from a variety of sources have been defined as Real-World Data (RWD) by the FDA. On the other hand, Real-World Evidence (RWE) is described as clinical evidence about the usage and potential benefits or risks of a medical product derived from an analysis of RWD. RWD and RWE offer the possibility to bring about novel insights on patients’ clinical care, regulatory decision-making, and health technology assessment. Detailed information on data sources, data standards, data reliability, how to generate evidence, and regulatory considerations can be found on FDA’s document titled Framework for FDA’s Real-World Evidence Program (U.S. FDA, 2018). In oncology, RWE refers to evidence derived from the use and analysis of real-world data, which are data obtained outside the context of conventional randomized controlled trials (Khozin et al., 2017).