Real world data
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
Regional context
USA context
In December 2018, FDA published a framework for Real World Evidence program.[2]
EU context
In 2018, EMA published a discussion paper on the use of patient disease registries for regulatory purposes (methodological and operational considerations) [3].
See also
- Real world evidence
- 21st Century Cures Act (USA)
- Correlation does not imply causation
- Qualitative research
- Quantitative research
References
- 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.
- ^ Cowley, Andrea. "What is real world data?". CRC Australia. Clinical Research Corporation. Retrieved 8 May 2018.
- ^ "Framework for FDA's Real-World Evidence Program" (PDF). FDA.
- ^ "Use of patient disease registries for regulatory purposes – methodological and operational considerations".
External links
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