Table 2.

Definitions of real-world data by FDA, EMA, Japanese Health Science Council, JPMA Ethical Drug Product Information Summary Review Committee, and joint ISPOR-ISPE special task force

Organization	RWD definition
FDA [15]	Real-world data are the data relating to patient health status and/or the delivery of the healthcare routinely collected from a variety of sources RWD can come from a number of sources, for example: Electronic health records (EHRs) Claims and billing activities Product and disease registries Patient-generated data including in home-use settings Data gathered from other sources that can inform on health status, such as mobile devices
EMA [17]	RWD are defined as “routinely collected data relating to a patient’s health status or the delivery of healthcare from a variety of sources other than traditional clinical trials” Data from traditional clinical trials are especially excluded, even single-arm trials, but would incorporate data from pragmatic clinical trials if data were collected remotely through an electronic health record or other observational data source and solely under conditions of normal care
Japanese Health Science Council [18]	Variety of electronic data collected in a clinical setting that can be evaluated for safety and efficacy
JPMA Ethical Drug Product Information Summary Review Committee [19]	Includes data based on actual practice (e.g., Receipt data, DPC data, medical records, registry), data from pragmatic trials and non-interventional studies that resemble the conditions of actual practice Data may reflect some or a significant portion of the “as it is non-intervention” decisions and behaviors of practitioners and patients in clinical practice
Joint ISPOR-ISPE special task force [20]	Data obtained outside the context of RCTs generated during routine clinical practice

DPC Diagnosis Procedure Combination, EMA European Medicines Agency, FDA US Food and Drug Administration, ISPE International Society for Pharmacoepidemiology, ISPOR International Society for Pharmacoeconomics and Outcomes Research, JPMA Japan Pharmaceutical Manufacturers Association, RCT randomized controlled trial, RWD real-world data