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: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
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)
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:
Real-world data "relates to patient health status and/or the delivery of health care routinely collected from a variety of sources."
Some examples include:
- Electronic health records
- Claims and billing activities
- Product and disease registries
- Patient-generated data including in home-use settings
- Mobile device dataReal-world evidence is "clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world evidence."
Some examples include:
- Randomized trials
- Large simple trials
- Pragmatic trials
- Observational studies (prospective and/or retrospective).Zelko, Jacob. Real-World Data and Real-World Evidence. https://jacobzelko.com/10282021140730-real-world-evidence. October 28 2021.