Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models.
Journal
Scientific data
ISSN: 2052-4463
Titre abrégé: Sci Data
Pays: England
ID NLM: 101640192
Informations de publication
Date de publication:
08 08 2023
08 08 2023
Historique:
received:
30
09
2021
accepted:
01
08
2023
medline:
10
8
2023
pubmed:
9
8
2023
entrez:
8
8
2023
Statut:
epublish
Résumé
The impact and effectiveness of clinical trial data sharing initiatives may differ depending on the data sharing model used. We characterized outcomes associated with models previously used by the U.S. National Institutes of Health (NIH): National Heart, Lung, and Blood Institute's (NHLBI) centralized model and National Cancer Institute's (NCI) decentralized model. We identified trials completed in 2010-2013 that met NIH data sharing criteria and matched studies based on cost and/or size, determining whether trial data were shared, and for those that were, the frequency of secondary internal publications (authored by at least one author from the original research team) and shared data publications (authored by a team external to the original research team). We matched 77 NHLBI-funded trials to 77 NCI-funded trials; among these, 20 NHLBI-sponsored trials (26%) and 4 NCI-sponsored trials (5%) shared data (OR 6.4, 95% CI: 2.1, 19.8). From the 4 NCI-sponsored trials sharing data, we identified 65 secondary internal and 2 shared data publications. From the 20 NHLBI-sponsored trials sharing data, we identified 188 secondary internal and 53 shared data publications. The NHLBI's centralized data sharing model was associated with more trials sharing data and more shared data publications when compared with the NCI's decentralized model.
Identifiants
pubmed: 37553403
doi: 10.1038/s41597-023-02436-0
pii: 10.1038/s41597-023-02436-0
pmc: PMC10409750
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
529Subventions
Organisme : NIA NIH HHS
ID : R38 AG065762
Pays : United States
Organisme : AHRQ HHS
ID : R01 HS022882
Pays : United States
Organisme : FDA HHS
ID : U01 FD005938
Pays : United States
Organisme : AHRQ HHS
ID : R01 HS025164
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL144644
Pays : United States
Informations de copyright
© 2023. Springer Nature Limited.
Références
BMJ. 2018 Feb 13;360:k400
pubmed: 29440066
Biopreserv Biobank. 2015 Aug;13(4):271-9
pubmed: 26186276
JAMA. 2013 Apr 3;309(13):1355-6
pubmed: 23508736
Med Ref Serv Q. 2023 Jan-Mar;42(1):71-78
pubmed: 36862609
JAMA. 2021 Dec 14;326(22):2259-2260
pubmed: 34734966
BMJ. 2013 Jul 30;347:f4794
pubmed: 23900826
Trials. 2011 Nov 23;12:249
pubmed: 22112900
JAMA Netw Open. 2023 Jul 3;6(7):e2325342
pubmed: 37490293
Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):141-2
pubmed: 22438459
Trials. 2013 Jul 09;14:201
pubmed: 23837497
Clin Trials. 2021 Dec;18(6):657-666
pubmed: 34407656
BMJ. 2015 Feb 05;350:h599
pubmed: 25655137
AMA J Ethics. 2015 Dec 01;17(12):1152-9
pubmed: 26698589
Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):238-40
pubmed: 22438465
BMJ Open. 2016 Oct 13;6(10):e011784
pubmed: 27737882
Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):499-504
pubmed: 24891590
Sci Data. 2023 Aug 8;10(1):529
pubmed: 37553403