Choosing Among Common Data Models for Real-World Data Analyses Fit for Making Decisions About the Effectiveness of Medical Products
- PMID: 31330042
- DOI: 10.1002/cpt.1577
Choosing Among Common Data Models for Real-World Data Analyses Fit for Making Decisions About the Effectiveness of Medical Products
Abstract
Many real-world data analyses use common data models (CDMs) to standardize terminologies for medication use, medical events and procedures, data structures, and interpretations of data to facilitate analyses across data sources. For decision makers, key aspects that influence the choice of a CDM may include (i) adaptability to a specific question; (ii) transparency to reproduce findings, assess validity, and instill confidence in findings; and (iii) ease and speed of use. Organizing CDMs preserve the original information from a data source and have maximum adaptability. Full mapping data models, or preconfigured rules systems, are easy to use, since all raw codes are mapped to medical constructs. Adaptive rule systems grow libraries of reusable measures that can easily adjust to preserve adaptability, expedite analyses, and ensure study-specific transparency.
© 2019 The Authors Clinical Pharmacology & Therapeutics © 2019 American Society for Clinical Pharmacology and Therapeutics.
References
-
- Jarow, J.P., LaVange, L. & Woodcock, J. Multidimensional evidence generation and FDA regulatory decision making: defining and using “real-world” data. JAMA 318, 703-704 (2017).
-
- US Food and Drug Administration. Framework for FDA's Real-World Evidence Program (US Food and Drug Administration, Washington, DC, 2018).
-
- Schneeweiss, S. & Avorn, J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J. Clin. Epidemiol. 58, 323-337 (2005).
-
- Fischer, M.A. et al. Primary medication non-adherence: analysis of 195,930 electronic prescriptions. J. Gen. Intern. Med. 25, 284-290 (2010).
-
- Toh, S. et al. Prospective postmarketing surveillance of acute myocardial infarction in new users of saxagliptin: a population-based study. Diabetes Care 41, 39-48 (2018).
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