Considerations in characterizing real-world data relevance and quality for regulatory purposes: A commentary

Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):439-442. doi: 10.1002/pds.4697. Epub 2018 Dec 5.

Authors

Cynthia J Girman¹, Mary E Ritchey², Wei Zhou³, Nancy A Dreyer⁴

Affiliations

¹ Patient-reported Outcomes and Real-world Evidence, CERobs Consulting, LLC, Chapel Hill, North Carolina.
² Epidemiology, Medical Devices, and Real-World Evidence, RTI-Health Solutions, Research Triangle Park, Durham, North Carolina.
³ Department of Pharmacoepidemiology, Center for Observational and Real-world Evidence, Merck & Co., Inc, North Wales, Pennsylvania.
⁴ Real-World & Analytic Solutions, IQVIA, Cambridge, Massachusetts.

No abstract available

MeSH terms

Data Accuracy*
Drug Approval / legislation & jurisprudence*
Pragmatic Clinical Trials as Topic / legislation & jurisprudence
Pragmatic Clinical Trials as Topic / standards*
Research Design / standards*
United States
United States Food and Drug Administration / legislation & jurisprudence*