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- Title
Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.
- Authors
Corrigan-Curay, Jacqueline; Sacks, Leonard; Woodcock, Janet
- Abstract
In this Viewpoint, Janet Woodcock and CDER colleagues discuss recent FDA initiatives to investigate the adequacy of electronic health record (EHR) and patient database data for research purposes and to understand if and how real-world observational data might be analyzed in ways that mimic or can be as reliable as randomized trials.
- Subjects
UNITED States; ELECTRONIC health records; COMPUTERS in the health care industry; MEDICAL records; UNITED States. Food &; Drug Administration; CLINICAL trials; DRUG approval laws; MEDICAL research; EVIDENCE-based medicine; DRUG approval; ACQUISITION of data
- Publication
JAMA: Journal of the American Medical Association, 2018, Vol 320, Issue 9, p867
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2018.10136