Pharmacoepidemiology in the Era of Real-World Evidence

Project Title Pharmacoepidemiology in the Era of Real-World Evidence
Wednesday, October 18, 2017

Long before the terms real-world data (RWD) and real-world evidence (RWE) were coined, researchers had been using data collected as part of routine healthcare delivery to generate evidence about the utilization, benefits, and risks of medical products. There are several variations to the definitions of RWD and RWE, but most are similar to the ones used by the US Food and Drug Administration (FDA), which defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” and RWE as “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD”. This commentary focuses on how pharmacoepidemiology can move forward in several domains in the era of RWD and RWE.

Corresponding Author

S. Toh, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, 401 Park Drive, Suite 401 East, Boston, MA 02215, USA. Email:


Sengwee Toh ScD