Real-world evidence (RWE) in medicine is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and retrospective or prospective observational studies.[1] In the USA the 21st Century Cures Act required the FDA to expand the role of real world evidence.[2]
Real-world evidence comes into play when clinical trials cannot really account for the entire patient population of a particular disease. Patients with comorbidities or belonging to a distant geographic region or age limit who did not participate in any clinical trial may not respond to the treatment in question as expected. RWE provides answers to these problems and also to analyze effects of drugs over a longer period of time. Pharmaceutical companies and health insurance payers study RWE to understand patient pathways to deliver appropriate care for appropriate individuals and to minimize their own financial risk by investing on drugs that work for patients.[3]
- ^ "Real-World Evidence". www.fda.gov. Retrieved 2022-09-19.
- ^ "Text - H.R.34 - 114th Congress (2015-2016): 21st Century Cures Act | Congress.gov | Library of Congress".
- ^ Commissioner, Office of the (April 25, 2023). "Real-World Evidence". FDA.
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