The Real-World Evidence Glossary

Last updated: August 15, 2020

Realizing the promise of real-world data requires alignment and consensus across many fronts, including the vocabulary of this emerging field. Here, we aim to define the terms frequently used when discussing RWD and will update this page as the broader community adopts common definitions.

External Control
An external control compares a group of trial participants receiving the test treatment with a group of patients external to the study, for example patients who are being treated with standard of care in the real world. This is in contrast to using an internal control group consisting of patients from the same population assigned to a different treatment (traditional control). The external control can be a group of patients treated at an earlier time (historical control) or a group treated during the same time period but in another setting.
Variants:

External comparator, contemporaneous comparator, historical control

Key Resources:

Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials

Real-World Data
Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. (Examples include: electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices.)
Variants:

RWD

Key Resources:

Framework for FDA's Real-World Evidence Program

Real-World Endpoints
Real-world endpoints are precisely defined variables intended to reflect outcomes of interest that are statistically analyzed to address a particular research question. (Examples include: real-world overall survival (rwOS); real-world progression-free survival (rwPFS); and rwRR (real-world response rate))
Variants:

Real-World Outcomes

Key Resources:

BEST (Biomarkers, EndpointS, and other Tools) Resource

Real-World Evidence
Real-world evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.
Variants:

RWE

Key Resources:

Framework for FDA's Real-World Evidence Program