Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG)

Hongbo Yuan; M Sanni Ali; Emily S Brouwer; Cynthia J Girman; Jeff J Guo; Jennifer L Lund; Elisabetta Patorno; Jonathan L Slaughter; Xuerong Wen; Dimitri Bennett; ISPE Comparative Effectiveness Research Special Interest Group

doi:10.1002/cpt.1086

Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG)

Clin Pharmacol Ther. 2018 Aug;104(2):239-241. doi: 10.1002/cpt.1086. Epub 2018 May 7.

Authors

Affiliations

¹ Canadian Agency for Drugs and Technologies in Health, Ottawa, Ontario, Canada.
² Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
³ Center for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.
⁴ Shire Pharmaceuticals, Lexington, Massachusetts, USA.
⁵ Department of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, Kentucky, USA.
⁶ CERobs Consulting, LLC, Chapel Hill, North Carolina, USA.
⁷ Pharmacy Practice & Administrative Sciences, University of Cincinnati College of Pharmacy, Cincinnati, Ohio, USA.
⁸ Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.
⁹ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
¹⁰ Center for Perinatal Research, Nationwide Children's Hospital and Department of Pediatrics, Ohio State University, Columbus, Ohio, USA.
¹¹ Health Outcomes, Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, Rhode Island, USA.
¹² Department of Pharmacoepidemiology, Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA.

PMID: 29733448
DOI: 10.1002/cpt.1086

Abstract

On December 8, 2016, the New England Journal of Medicine published a sounding board on Real World Evidence (RWE)¹ by the US Food and Drug Administration (FDA) leadership. While the value of RWE based on nonrandomized observational studies was appreciated, such as for hypothesis generating, safety, and measuring quality in healthcare delivery, the authors expressed concerns on the quality of data sources and the ability of methodologies to control for confounding. In response, we offer a few considerations regarding these concerns.

Publication types

Comment

MeSH terms

Comparative Effectiveness Research*
Delivery of Health Care
Pharmacoepidemiology*
Public Opinion
United States
United States Food and Drug Administration