MAY 10, 2019

What We’re Learning: What is Real World Evidence, summary of presentation by Dr. Mark Weiner, PaTH-Temple

To understand what “Real World Evidence” entails, we must first describe the understanding of real world data. Real world data are data related to patient health status and/or delivery of health care that is routinely collected from various sources. These sources may include electronic health record, administrative or claims data, data collected directly from patients or providers in the course of an observational study, data from patient generated information that includes sources outside of a clinical setting, and in research registries.¹ In other words, data that is not limited only to data that is collected in the context of a research study. Real world evidence is derived from real world data though applying research methods; it is not merely anecdotes that are based on real world data. Data curation, validation, and standardization to ensure that data is fit-for-purpose is involved, as well as thoughtful study design.

1 https://www.fda.gov/ScienceResearch/SpecialTopics/RealWorldEvidence/default.htm .