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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

Bibliography

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

Table of Contents

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

Background

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:

Some examples include:

How To Cite

Zelko, Jacob. Real-World Data and Real-World Evidence. https://jacobzelko.com/10282021140730-real-world-evidence. October 28 2021.

References:

Discussion:

CC BY-SA 4.0 Jacob Zelko. Last modified: May 24, 2023. Website built with Franklin.jl and the Julia programming language.