Real World Evidence: Time for a Switch?
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Real World Evidence (RWE) provides critical information about the performance of medicines in routine clinical practice, as actually prescribed by physicians and taken by patients. For decades, observational designs and electronic healthcare databases have been used to characterize patient populations, describe the natural history of diseases, assess postapproval safety and conduct risk management programs as part of the drug development lifecycle. These approaches have evolved in recent years due to advances in electronic data collection, data linkage, computing power, the greater availability of analytic tools and methodologies, and established best practices. The US FDA Sentinel Initiative illustrates these advances well by rapidly generating evidence (in days, not months) in large populations (more than half of the US population in some analyses) and with increased transparency . These advances have made possible the potential use of these systems for outcomes other than...
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Conflicts of interest
Rachel E. Sobel, Andrew Bate, and Robert F. Reynolds are employees and shareholders of Pfizer, which manufactures both generic and branded medicines. The views expressed in this paper are those of the authors and may not necessarily reflect the views or opinions of Pfizer.
No sources of funding were used to assist in the preparation of this commentary.
- 2.US FDA. Prescription Drug User Fee Act Reauthorization (PDUFA VI), Medical Device User Fee Act Reauthorization (MDUFA IV), Generic Drug User Fee Act Reauthorization (GDUFA II), and Biosimilar User Fee Act Reauthorization (BsUFA II). 2017. https://www.fda.gov/NewsEvents/Testimony/ucm547898.htm. Accessed 25 Sep 2018.
- 5.Barlas S. Frustration over generic drug shortages and prices prompts federal and private actions: health systems take matters into their own hands. Pharmacy Ther. 2018;43(4):211.Google Scholar
- 11.Bate A, et al. Oral contraceptives and VTE across the Sentinel data network: an IMEDS evaluation pilot assessment. Pharmacoepidemiol Drug Saf. 2016;25(Suppl 3):S531.Google Scholar
- 12.Sobel RE, et al. Risk minimization evaluation in a distributed data network: an IMEDS evaluation pilot assessment of the 2010 class label change for proton pump inhibitors. Pharmacoepidemiol Drug Saf. 2016;25(Suppl 3):S6.Google Scholar
- 15.Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 375: brand versus generic oral contraceptives. Obstet Gynecol. 2007;110(2 Pt 1):447–8.Google Scholar
- 16.US FDA. FDA updates on valsartan recalls. 2018. https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm. Accessed 15 Sep 2018.
- 17.European Medicines Agency. Workshop: measuring the impact of pharmacovigilance activities. 2016. https://www.ema.europa.eu/events/workshop-measuring-impact-pharmacovigilance-activities. Accessed 25 Aug 2018.
- 18.European Medicines Agency. PRAC strategy on measuring the impact of pharmacovigilance activities (rev 1). 2017. https://www.ema.europa.eu/documents/other/prac-strategy-measuring-impact-pharmacovigilance-activities_en.pdf. Accessed 4 Oct 2018.