Real world data

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Real world data (RWD) in medicine is data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings, such as patient surveys, clinical trials, and observational cohort studies.[1] Real-world data refer to observational data as opposed to data gathered in an experimental setting such as a randomized controlled trial (RCT). They are derived from electronic health records (EHRs), claims and billing activities, product and disease registries, etc.

Real world evidence (RWE)[edit]

When working with RWD, the goal is often to generate evidence. The term real world evidence (RWE) is highly related to RWD. RWE is defined by FDA as "clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD".[2]

Regional context[edit]

US context[edit]

In December 2018, the FDA published a framework for Real World Evidence program.[2]

EU context[edit]

In 2018, the EMA published a discussion paper on the use of patient disease registries for regulatory purposes (methodological and operational considerations).[3]

See also[edit]



  1. ^ Cowley, Andrea. "What is real world data?". CRC Australia. Clinical Research Corporation. Retrieved 8 May 2018.
  2. ^ a b "Framework for FDA's Real-World Evidence Program". FDA.
  3. ^ "Use of patient disease registries for regulatory purposes – methodological and operational considerations".


  • Real-World Evidence—What Is It and What Can It Tell Us? The New England Journal of Medicine, Dec. 6, 2016
  • Mahajan, Rajiv. “Real World Data: Additional Source for Making Clinical Decisions.” International Journal of Applied and Basic Medical Research 5.2 (2015): 82. PMC. Web. 5 May 2018.

External links[edit]