Pharmacoepidemiology and Drug Safety

, volume 33 , issue 10 , publication number e70028

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

Rishi J. Desai ¹

Keith Marsolo ²

Joshua Smith ³

David Carrell ⁴

Robert Penfold ⁴

Haritha S Pillai ¹

Joyce Lii ¹

Kerry Ngan ¹

ROBERT WINTER ³

Margaret Adgent ⁵

Arvind Ramaprasan ⁴

Meighan Rogers Driscoll ⁶

Daniel Scarnecchia ⁶

Daniel Kiernan ⁶

Christine Draper ⁶

Jennifer G. Lyons ⁶

Anjum Khurshid ⁶

Judith Maro ⁶

Ruth Zimmerman ⁷

Jeffrey Brown ⁸

Patricia Bright ⁹

José J Hernández-Muñoz ⁹

Michael E Matheny ^{3, 10}

Sebastian Schneeweiss ¹

Hide authors affiliations Show authors affiliations: 10 affiliations

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

Harvard University

Brigham and Women's Hospital

Department of Population Health Sciences Duke University Durham North Carolina USA |

Department of Biomedical Informatics Vanderbilt University Medical Center Nashville Tennessee USA |

⁴

Kaiser Permanente Washington Health Research Institute Seattle Washington State USA |

⁵

Department of Health Policy Vanderbilt University Medical Center Nashville Tennessee USA |

⁶

Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School Boston Massachusetts USA |

⁷

HealthVerity Philadelphia Pennsylvania USA |

⁸

TriNetX, LLC Cambridge Massachusetts USA |

⁹

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

¹⁰

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

Publication type: Journal Article

Publication date: 2024-10-10

Wiley

Pharmacoepidemiology and Drug Safety

scimago Q1

wos Q2

SJR: 1.022

CiteScore: 3.7

Impact factor: 2.4

ISSN: 10538569, 10991557

DOI: 10.1002/pds.70028

Copy DOI

PubMed ID: 39385712

Abstract

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 Real‐World Evidence Data Enterprise (RWE‐DE), including data from two commercial EHR‐claims linked assets collectively termed the Commercial Network covering 21 million lives, and four academic partner institutions collectively termed the Development Network covering 4.5 million lives.

Results

We discuss provenance and completeness of the data converted in the Sentinel Common Data Model (SCDM), describe patient populations, and report on EHR‐claims linkage characterization for all contributing data sources. Further, we introduce a standardized process to store free‐text notes in the Development Network for efficient retrieval as needed.

Conclusions

Finally, we outline typical use cases for the RWE‐DE where it can broaden the reach of the types of questions that can be addressed by the Sentinel system.

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GOST Copy

Desai R. J. et al. The FDA Sentinel Real World Evidence Data Enterprise (RWE‐DE) // Pharmacoepidemiology and Drug Safety. 2024. Vol. 33. No. 10. e70028

GOST all authors (up to 50) Copy

Desai R. J., Marsolo K., Smith J., Carrell D., Penfold R., Pillai H. S., Lii J., Ngan K., WINTER R., Adgent M., Ramaprasan A., Driscoll M. R., Scarnecchia D., Kiernan D., Draper C., Lyons J. G., Khurshid A., Maro J., Zimmerman R., Brown J., Bright P., Hernández-Muñoz J. J., Matheny M. E., Schneeweiss S. The FDA Sentinel Real World Evidence Data Enterprise (RWE‐DE) // Pharmacoepidemiology and Drug Safety. 2024. Vol. 33. No. 10. e70028

RIS |

Cite this

RIS Copy

TY - JOUR

DO - 10.1002/pds.70028

UR - https://onlinelibrary.wiley.com/doi/10.1002/pds.70028

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

T2 - Pharmacoepidemiology and Drug Safety

AU - Desai, Rishi J.

AU - Marsolo, Keith

AU - Smith, Joshua

AU - Carrell, David

AU - Penfold, Robert

AU - Pillai, Haritha S

AU - Lii, Joyce

AU - Ngan, Kerry

AU - WINTER, ROBERT

AU - Adgent, Margaret

AU - Ramaprasan, Arvind

AU - Driscoll, Meighan Rogers

AU - Scarnecchia, Daniel

AU - Kiernan, Daniel

AU - Draper, Christine

AU - Lyons, Jennifer G.

AU - Khurshid, Anjum

AU - Maro, Judith

AU - Zimmerman, Ruth

AU - Brown, Jeffrey

AU - Bright, Patricia

AU - Hernández-Muñoz, José J

AU - Matheny, Michael E

AU - Schneeweiss, Sebastian

PY - 2024

DA - 2024/10/10

PB - Wiley

IS - 10

VL - 33

PMID - 39385712

SN - 1053-8569

SN - 1099-1557

ER -

BibTex

Cite this

BibTex (up to 50 authors) Copy

@article{2024_Desai,

author = {Rishi J. Desai and Keith Marsolo and Joshua Smith and David Carrell and Robert Penfold and Haritha S Pillai and Joyce Lii and Kerry Ngan and ROBERT WINTER and Margaret Adgent and Arvind Ramaprasan and Meighan Rogers Driscoll and Daniel Scarnecchia and Daniel Kiernan and Christine Draper and Jennifer G. Lyons and Anjum Khurshid and Judith Maro and Ruth Zimmerman and Jeffrey Brown and Patricia Bright and José J Hernández-Muñoz and Michael E Matheny and Sebastian Schneeweiss},

title = {The FDA Sentinel Real World Evidence Data Enterprise (RWE‐DE)},

journal = {Pharmacoepidemiology and Drug Safety},

year = {2024},

volume = {33},

publisher = {Wiley},

month = {oct},

url = {https://onlinelibrary.wiley.com/doi/10.1002/pds.70028},

number = {10},

pages = {e70028},

doi = {10.1002/pds.70028}

}

Publisher

Wiley

Journal

Pharmacoepidemiology and Drug Safety

scimago Q1

wos Q2

SJR

1.022

CiteScore

3.7

Impact factor

2.4

ISSN

10538569 (Print)

10991557 (Electronic)

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