Affiliation:
1. Diabetes Research Institute; Mills-Peninsula Health Services, San Mateo, CA, USA
Abstract
Real-world evidence (RWE) is the clinical evidence about benefits or risks of medical products derived from analyzing real world data (RWD), which are data collected through routine clinical practice. This article discusses the advantages and disadvantages of RWE studies, how these studies differ from randomized controlled trials (RCTs), how to overcome barriers to current skepticism about RWE, how FDA is using RWE, how to improve the quality of RWE, and finally the future of RWE trials.
Subject
Biomedical Engineering,Bioengineering,Endocrinology, Diabetes and Metabolism,Internal Medicine
Cited by
48 articles.
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