the cedar ledge

Real-World Data and Real-World Evidence

Date: October 28 2021

Summary: A summary of what real-world data and evidence is according to the United States Food and Drug Administration

Keywords: ##summary #real #world #data #evidence #fda #archive


U.S. Food and Drug Administration, "Real-World Evidence." Sep. 30, 2021. Accessed: Oct. 27, 2021. [Online]. Available:

Table of Contents

    1. Background
    2. United States Food and Drug Administration Definitions
  1. How To Cite
  2. References:
  3. Discussion:


Real-World Evidence, according to Congress, is any data that concerns the use, benefits, or risks of a drug from nontraditional sources (i.e. clinical trials)

United States Food and Drug Administration Definitions

The United States Food and Drug Administration found this definition from Congress to be too expansive and vague. For their purposes, they limited the language further to make the definitions less vague. Here they are:

Some examples include:

- Electronic health records
- Claims and billing activities
- Product and disease registries 
- Patient-generated data including in home-use settings 
- Mobile device data

Some examples include:

- Randomized trials 
	- Large simple trials
	- Pragmatic trials
	- Observational studies (prospective and/or retrospective).

How To Cite

Zelko, Jacob. Real-World Data and Real-World Evidence. October 28 2021.



CC BY-SA 4.0 Jacob Zelko. Last modified: January 17, 2023. Website built with Franklin.jl and the Julia programming language.