Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.

Biomedical Research Databases, Pharmaceutical Health Information Systems Humans Product Surveillance, Postmarketing Renal Insufficiency, Chronic / therapy United States United States Food and Drug Administration
Sentinel Initiative U.S. Food and Drug Administration electronic health data epidemiology outcomes research real-world evidence

Journal

Journal of the American Society of Nephrology : JASN
ISSN: 1533-3450
Titre abrégé: J Am Soc Nephrol
Pays: United States
ID NLM: 9013836

Informations de publication

Date de publication:
11 2020
Historique:
pubmed: 21 10 2020
medline: 10 3 2021
entrez: 20 10 2020
Statut: ppublish

Résumé

The Sentinel System is a national electronic postmarketing resource established by the US Food and Drug Administration to support assessment of the safety and effectiveness of marketed medical products. It has built a large, multi-institutional, distributed data network that contains comprehensive electronic health data, covering about 700 million person-years of longitudinal observation time nationwide. With its sophisticated infrastructure and a large selection of flexible analytic tools, the Sentinel System permits rapid and secure analyses, while preserving patient privacy and health-system autonomy. The Sentinel System also offers enhanced capabilities, including accessing full-text medical records, supporting randomized clinical trials embedded in healthcare delivery systems, and facilitating effective collection of patient-reported data using mobile devices, among many other research programs. The nephrology research community can use the infrastructure, tools, and data that this national resource offers for evidence generation. This review summarizes the Sentinel System and its ability to rapidly generate high-quality, real-world evidence; discusses the program's experience in, and potential for, addressing gaps in kidney care; and outlines avenues for conducting research, leveraging this national resource in collaboration with Sentinel investigators.

Identifiants

DOI: 10.1681/ASN.2020040526 PMID: 33077615 PMC: PMC7608970
pubmed: 33077615
pii: ASN.2020040526
doi: 10.1681/ASN.2020040526
pmc: PMC7608970
doi:

Types de publication

Journal Article Research Support, N.I.H., Extramural Research Support, U.S. Gov't, P.H.S. Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

2506-2516

Subventions

Organisme : FDA HHS
ID : HHSF223201400030I
Pays : United States
Organisme : NIAID NIH HHS
ID : K23 AI143882
Pays : United States

Informations de copyright

Copyright © 2020 by the American Society of Nephrology.

Références

Med Care. 2010 Jun;48(6 Suppl):S45-51
pubmed: 20473204
Clin J Am Soc Nephrol. 2018 Dec 7;13(12):1897-1908
pubmed: 29622670
Pharmacoepidemiol Drug Saf. 2018 Sep;27(9):1034-1041
pubmed: 30022561
Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:291-7
pubmed: 22262619
Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1692-1700
pubmed: 31672794
Nephrol Dial Transplant. 2020 Jan 1;35(Suppl 1):i48-i55
pubmed: 32003833
BMC Nephrol. 2014 Apr 22;15:64
pubmed: 24755164
JAMA Netw Open. 2019 May 3;2(5):e192535
pubmed: 31050774
J Comp Eff Res. 2017 Jan;6(1):25-32
pubmed: 27935320
PLoS One. 2015 Jul 07;10(7):e0132970
pubmed: 26151753
EGEMS (Wash DC). 2016 Mar 30;4(2):1213
pubmed: 27141522
BMJ. 2014 May 29;348:g3244
pubmed: 24874977
Clin Pharmacol Ther. 2016 Nov;100(5):558-564
pubmed: 27416001
Am J Epidemiol. 2012 Jun 1;175(11):1120-8
pubmed: 22582207
Pharmacoepidemiol Drug Saf. 2013 May;22(5):517-23
pubmed: 23512870
Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):332-339
pubmed: 29392851
N Engl J Med. 2016 Jul 28;375(4):323-34
pubmed: 27299675
Support Care Cancer. 2020 Jun;28(6):2553-2562
pubmed: 31494735
EGEMS (Wash DC). 2016 Mar 22;4(2):1205
pubmed: 27141518
Am J Epidemiol. 2019 Apr 1;188(4):709-723
pubmed: 30535131
J Manag Care Spec Pharm. 2019 Nov;25(11):1156-1161
pubmed: 31397619
Health Aff (Millwood). 2014 Jul;33(7):1178-86
pubmed: 25006144
Lancet Diabetes Endocrinol. 2020 Jan;8(1):27-35
pubmed: 31862149
Am Heart J. 2020 Nov;229:110-117
pubmed: 32949986
N Engl J Med. 2018 Mar 29;378(13):1200-1210
pubmed: 29527974
J Am Soc Nephrol. 2020 Feb;31(2):435-446
pubmed: 31896554
Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:9-11
pubmed: 22262587
Ann Intern Med. 2009 Sep 1;151(5):341-4
pubmed: 19638403
Pediatrics. 2020 Jul;146(1):
pubmed: 32513842
Pharmacoepidemiol Drug Saf. 2019 Mar;28(3):296-304
pubmed: 30430682
Clin Trials. 2019 Feb;16(1):90-97
pubmed: 30445835
N Engl J Med. 2014 Feb 6;370(6):503-12
pubmed: 24422676
Epidemiology. 2018 Nov;29(6):895-903
pubmed: 30074538
Clin Pharmacol Ther. 2020 Apr;107(4):966-977
pubmed: 31630391
Prim Care Diabetes. 2018 Jun;12(3):265-283
pubmed: 29482993
PLoS Med. 2019 Jul 2;16(7):e1002844
pubmed: 31265459
N Engl J Med. 2011 Feb 10;364(6):498-9
pubmed: 21226658
Eur J Epidemiol. 2017 Jul;32(7):567-582
pubmed: 28698923
Kidney Int. 2015 Aug;88(2):226-34
pubmed: 25853333
Arch Intern Med. 2012 Nov 12;172(20):1582-9
pubmed: 23147456
PLoS One. 2019 Dec 5;14(12):e0223515
pubmed: 31805056
N Engl J Med. 2018 Nov 29;379(22):2091-2093
pubmed: 30485777
Diabetes Care. 2020 Jan;43(1):90-97
pubmed: 31601640

Auteurs

Sruthi Adimadhyam (S)

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts Sruthi_Adimadhyam@harvardpilgrim.org.

Erin F Barreto (EF)

Department of Pharmacy, Mayo Clinic, Rochester, Minnesota.
Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota.

Noelle M Cocoros (NM)

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

Sengwee Toh (S)

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

Jeffrey S Brown (JS)

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

Judith C Maro (JC)

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
ORCID: 0000-0001-9900-2142

Jacqueline Corrigan-Curay (J)

Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

Gerald J Dal Pan (GJ)

Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

Robert Ball (R)

Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

David Martin (D)

Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

Michael Nguyen (M)

Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

Richard Platt (R)

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

Xiaojuan Li (X)

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
ORCID: 0000-0002-1305-0846

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