The <scp>FDA</scp> Sentinel Real World Evidence Data Enterprise (<scp>RWE</scp>‐<scp>DE</scp>)
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.
Authors
- Sebastian Schneeweiß (ORCID: https://orcid.org/0000-0003-2575-467X)
- Patricia Bright
- Anjum Khurshid (ORCID: https://orcid.org/0000-0002-8946-0622)
- Rishi Desai (ORCID: https://orcid.org/0000-0003-0299-7273)
- Daniel Kiernan
- Meighan Rogers Driscoll (ORCID: https://orcid.org/0000-0003-1371-9658)
- Michael E. Matheny (ORCID: https://orcid.org/0000-0003-3217-4147)
- Robert Winter (ORCID: https://orcid.org/0000-0002-5013-503X)
- Keith A. Marsolo (ORCID: https://orcid.org/0000-0002-4416-1549)
- Joyce Lii
- David Carrell (ORCID: https://orcid.org/0000-0002-8471-0928)
- Arvind Ramaprasan
- Daniel Scarnecchia (ORCID: https://orcid.org/0000-0001-9486-4974)
- Jeffrey S. Brown (ORCID: https://orcid.org/0000-0002-9340-7189)
- Jennifer G. Lyons (ORCID: https://orcid.org/0000-0002-5224-0298)
- Robert B. Penfold (ORCID: https://orcid.org/0000-0003-4795-7902)
- José J. Hernández‐Muñoz (ORCID: https://orcid.org/0000-0002-2553-3159)
- Judith C. Maro (ORCID: https://orcid.org/0000-0001-9900-2142)
- Margaret A. Adgent (ORCID: https://orcid.org/0000-0002-5951-5514)
- Joshua Smith (ORCID: https://orcid.org/0000-0003-2661-3203)
- Haritha S. Pillai
- Kerry Ngan
- Christine Draper
- Ruth Zimmerman
Institutions
- Brigham and Women's Hospital (US)
- Center for Drug Evaluation and Research (US)
- Harvard University (US)
- Kaiser Permanente Washington Health Research Institute (US)
- Duke University (US)
- VA Tennessee Valley Healthcare System (US)
- Harvard Pilgrim Health Care (US)
- TriNetX (United States) (US)
- Vanderbilt University Medical Center (US)
Publication Details
- Journal
- Pharmacoepidemiology and Drug Safety
- Published
- 2024-10-01
- DOI
- https://doi.org/10.1002/pds.70028
- Citations
- 22
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 15.60
Funders
- Food and Drug Administration