Real-World Evidence - Where Are We Now?

By John Concato, M.D., M.P.H., and Jacqueline Corrigan‑Curay, J.D., M.D.

More than 5 years after the passage of the 21st Century Cures Act of 2016, the terms “real world data” (RWD) and “real-world evidence” (RWE) are being used inconsistently and sometimes interchangeably. This imprecision has complicated efforts to assess the impact of such data and evidence and hindered attempts to track their use.

The Food and Drug Administration (FDA), in its Framework for FDA’s Real-World Evidence Program,¹ defined RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” and defined RWE as “clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD,” regardless of the type of study design. But there are two widespread misconceptions about these terms.