FDA leaders Dr. John Concato and Dr. Jacqueline Corrigan-Curay published a perspective piece in the New England Journal of Medicine encouraging researchers to be more explicit and specific about the types of real-world data (RWD) they are using to generate real-world evidence (RWE).

The article, “Real-World Evidence — Where Are We Now?,” cautions that the terms RWD and RWE are too often used interchangeably and inconsistently in describing research and that this imprecision has led to confusion and an inability to assess the impact of RWD and RWE. The authors described 2 misconceptions about RWD and RWE. The first is that RWD is “new” when in fact real world sources of information have always existed; what is new is how researchers are able to access the information. The second misconception is that “a simple dichotomy between randomized, controlled trials (RCTs) and observational studies delineates the entire landscape of study design.” In fact, the authors write, the important distinction in study design is often interventional vs non-interventional.

The authors recommend precision in describing how RWD is incorporated into a variety of study designs to generate regulatory-grade RWE and cited recent examples of FDA approvals that were made possible by RWD. They also describe how the COVID-19 pandemic is changing perceptions about the potential of RWD and RWD.

Read the full article.