The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE).

Rishi J Desai¹, Keith Marsolo², Joshua Smith³, David Carrell⁴, Robert Penfold⁴, Haritha S Pillai¹, Joyce Lii¹, Kerry Ngan¹, Robert Winter³, Margaret Adgent⁵, Arvind Ramaprasan⁴, Meighan Rogers Driscoll⁶, Daniel Scarnecchia⁶, Daniel Kiernan⁶, Christine Draper⁶, Jennifer G Lyons⁶, Anjum Khurshid⁶, Judith C Maro⁶, Ruth Zimmerman⁷, Jeffrey Brown⁸, Patricia Bright⁹, José J Hernández-Muñoz⁹, Michael E Matheny^3,10, Sebastian Schneeweiss¹

¹Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

²Department of Population Health Sciences, Duke University, Durham, North Carolina, USA.

³Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

⁴Kaiser Permanente Washington Health Research Institute, Seattle, Washington State, USA.

⁵Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

⁶Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, USA.

⁷HealthVerity, Philadelphia, Pennsylvania, USA.

⁸TriNetX, LLC, Cambridge, Massachusetts, USA.

⁹Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA.

¹⁰Geriatrics Research Education and Clinical Care Center, Tennessee Valley Healthcare System VA, Nashville, Tennessee, USA.

PubMed DOI

Abstract

PURPOSE: The US Food and Drug Administration's Sentinel Innovation Center aimed to establish a query-ready, quality-checked distributed data network containing electronic health records (EHRs) linked with insurance claims data for at least 10 million individuals to expand the utility of real-world data for regulatory decision-making. METHODS: In this report, we describe the resulting network, the…

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