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

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.

Cynthia J Girman et al. Pharmacoepidemiol Drug Saf. 2019 Apr.

. 2019 Apr;28(4):439-442.

doi: 10.1002/pds.4697. Epub 2018 Dec 5.

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

References

1. Energy and Commerce Committee . 21st Century Cures Act. Retrieved 01OCT 2018 https://energycommerce.house.gov/cures
1. Wang SV, Schneeweiss S, Berger ML, et al. Reporting to improve reproducibility and facilitate validity assessment for healthcare database studies V1.0. Pharmacoepidemiol Drug Saf. 2017;26(9):1018‐1032. - PMC - PubMed
1. Center for drug evaluation and research. Prescription Drug User Fee Act (PDUFA)—PDUFA VI: fiscal years 2018–2022. U.S. Food and Drug Administration. Retrieved 01 October 2018. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm44660...
1. U.S. Food and Drug Administration . Use of real‐world evidence to support regulatory decision‐making for medical devices. Guidance for Industry and Food and Drug Administration staff. Center for Devices and Radiological Health (CDRH). Retrieved 12 October 2018. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance...
1. Berger, M , Daniel, G , Frank, K , et al. A framework for regulatory use of real world evidence. Retrieved 06SEPT2017. https://healthpolicy.duke.edu/sites/default/files/atoms/files/rwe_white_...