Health Affairs September 19, 2019
Tanisha Carino Mark B. McClellan

Evidence generated from randomized clinical trials and other clinical studies has long been the foundation for decisions by clinicians and patients about care, and has been used as a basis for coverage and payment decision. However, gaps in evidence from traditional clinical trials, coupled with progress in the availability and use of standardized electronic data, has led to increasing interest in real-world data (RWD) — recently defined by the U.S. Food and Drug Administration (FDA) as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

RWD increasingly guides drug and device developers on where to innovate, supports clinical decisions for individual patients, informs payer coverage and payment decisions, and focuses...