{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T22:03:52Z","timestamp":1793829832987,"version":"4.6.1"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,8,8]],"date-time":"2023-08-08T00:00:00Z","timestamp":1691452800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,8,8]],"date-time":"2023-08-08T00:00:00Z","timestamp":1691452800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100009827","name":"Laura and John Arnold Foundation","doi-asserted-by":"publisher","award":["No grant number"],"award-info":[{"award-number":["No grant number"]}],"id":[{"id":"10.13039\/100009827","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009827","name":"Laura and John Arnold Foundation","doi-asserted-by":"publisher","award":["No grant number"],"award-info":[{"award-number":["No grant number"]}],"id":[{"id":"10.13039\/100009827","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009827","name":"Laura and John Arnold Foundation","doi-asserted-by":"publisher","award":["No grant number"],"award-info":[{"award-number":["No grant number"]}],"id":[{"id":"10.13039\/100009827","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sci Data"],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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\u2019s (NHLBI) centralized model and National Cancer Institute\u2019s (NCI) decentralized model. We identified trials completed in 2010\u20132013 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\u2019s centralized data sharing model was associated with more trials sharing data and more shared data publications when compared with the NCI\u2019s decentralized model.<\/jats:p>","DOI":"10.1038\/s41597-023-02436-0","type":"journal-article","created":{"date-parts":[[2023,8,8]],"date-time":"2023-08-08T11:02:34Z","timestamp":1691492554000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models"],"prefix":"10.1038","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3637-2423","authenticated-orcid":false,"given":"Anisa","family":"Rowhani-Farid","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikas","family":"Grewal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Solar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allen O.","family":"Eghrari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9753-4276","authenticated-orcid":false,"given":"Audrey D.","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cary P.","family":"Gross","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2046-127X","authenticated-orcid":false,"given":"Harlan M.","family":"Krumholz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9218-3320","authenticated-orcid":false,"given":"Joseph S.","family":"Ross","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,8,8]]},"reference":[{"key":"2436_CR1","doi-asserted-by":"publisher","first-page":"1355","DOI":"10.1001\/jama.2013.1299","volume":"309","author":"J Ross","year":"2013","unstructured":"Ross, J. & Krumholz, H. Ushering in a new era of open science through data sharing: the wall must come down. JAMA 309, 1355\u20131356 (2013).","journal-title":"JAMA"},{"key":"2436_CR2","doi-asserted-by":"publisher","first-page":"238","DOI":"10.1161\/CIRCOUTCOMES.112.965798","volume":"5","author":"J Ross","year":"2012","unstructured":"Ross, J., Lehman, R. & Gross, C. The importance of clinical trial data sharing: toward more open science. Circ. Cardiovasc. Qual. Outcomes 5, 238\u2013240 (2012).","journal-title":"Circ. Cardiovasc. Qual. Outcomes"},{"key":"2436_CR3","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-12-249","volume":"12","author":"PC G\u00f8tzsche","year":"2011","unstructured":"G\u00f8tzsche, P. C. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 12, 249 (2011).","journal-title":"Trials"},{"key":"2436_CR4","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1161\/CIRCOUTCOMES.112.965848","volume":"5","author":"H Krumholz","year":"2012","unstructured":"Krumholz, H. Open science and data sharing in clinical research: basing informed decisions on the totality of the evidence. Circ. Cardiovasc. Qual. Outcomes 5, 141\u2013142 (2012).","journal-title":"Circ. Cardiovasc. Qual. Outcomes"},{"key":"2436_CR5","doi-asserted-by":"publisher","first-page":"1152","DOI":"10.1001\/journalofethics.2015.17.12.pfor1-1512","volume":"17","author":"DL Shaw","year":"2015","unstructured":"Shaw, D. L. & Ross, J. S. US Federal Government Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing. AMA J Ethics 17, 1152\u20131159 (2015).","journal-title":"AMA J Ethics"},{"key":"2436_CR6","doi-asserted-by":"crossref","unstructured":"Loder, E. Sharing data from clinical trials: where we are and what lies ahead. BMJ 347 (2013).","DOI":"10.1136\/bmj.f4794"},{"key":"2436_CR7","doi-asserted-by":"publisher","first-page":"499","DOI":"10.1161\/CIRCOUTCOMES.114.001166","volume":"7","author":"H Krumholz","year":"2014","unstructured":"Krumholz, H. et al. Sea change in open science and data sharing: leadership by industry. Circ. Cardiovasc. Qual. Outcomes 7, 499\u2013504 (2014).","journal-title":"Circ. Cardiovasc. Qual. Outcomes"},{"key":"2436_CR8","unstructured":"Varnai, P. et al. Assessing the research potential of access to clinical trial data. A report to the Wellcome Trust. Study led by Technopolis Group (UK) (2014)."},{"key":"2436_CR9","doi-asserted-by":"crossref","unstructured":"Krumholz, H. M. Why data sharing should be the expected norm. BMJ 350 (2015).","DOI":"10.1136\/bmj.h599"},{"key":"2436_CR10","unstructured":"Guidelines for Preparing Clinical Study Data Sets for Submission to the NHLBI Data Repository. https:\/\/www.nhlbi.nih.gov\/grants-and-training\/policies-and-guidelines\/guidelines-for-preparing-clinical-study-data-sets-for-submission-to-the-nhlbi-data-repository."},{"key":"2436_CR11","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-14-201","volume":"14","author":"SA Coady","year":"2013","unstructured":"Coady, S. A. & Wagner, E. Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI. Trials 14, 201 (2013).","journal-title":"Trials"},{"key":"2436_CR12","doi-asserted-by":"publisher","first-page":"2259","DOI":"10.1001\/jama.2021.20489","volume":"326","author":"LA Jorgenson","year":"2021","unstructured":"Jorgenson, L. A., Wolinetz, C. D. & Collins, F. S. Incentivizing a New Culture of Data Stewardship: The NIH Policy for Data Management and Sharing. JAMA 326, 2259\u20132260 (2021).","journal-title":"JAMA"},{"key":"2436_CR13","unstructured":"NOT-OD-21-013: Final NIH Policy for Data Management and Sharing. https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-21-013.html."},{"key":"2436_CR14","unstructured":"2023 NIH Data Management and Sharing Policy. https:\/\/oir.nih.gov\/sourcebook\/intramural-program-oversight\/intramural-data-sharing\/2023-nih-data-management-sharing-policy."},{"key":"2436_CR15","doi-asserted-by":"publisher","unstructured":"Vazquez, E. et al. Characteristics of available studies and dissemination of research using major clinical data sharing platforms. Clin. Trials 17407745211038524, https:\/\/doi.org\/10.1177\/17407745211038524 (2021).","DOI":"10.1177\/17407745211038524"},{"key":"2436_CR16","doi-asserted-by":"publisher","first-page":"271","DOI":"10.1089\/bio.2014.0050","volume":"13","author":"CA Giffen","year":"2015","unstructured":"Giffen, C. A. et al. Providing Contemporary Access to Historical Biospecimen Collections: Development of the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Biopreserv. Biobank. 13, 271\u2013279 (2015).","journal-title":"Biopreserv. Biobank."},{"key":"2436_CR17","unstructured":"NCI. NCI Clinical Trials Cooperative Group Program Data Sharing Policy. https:\/\/ctep.cancer.gov\/protocolDevelopment\/docs\/data_sharing_policy.doc (2006)."},{"key":"2436_CR18","author":"NCTN\/NCORP Data Archive","year":"2017","unstructured":"NCTN\/NCORP Data Archive. Expanding Access to Clinical Trial Data. National Cancer Institute https:\/\/www.cancer.gov\/news-events\/cancer-currents-blog\/2017\/nctn-ncorp-data-archive (2017)."},{"key":"2436_CR19","unstructured":"Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy & Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. in (National Academies Press, 2015)."},{"key":"2436_CR20","doi-asserted-by":"publisher","DOI":"10.17605\/OSF.IO\/T8B6G","author":"A Rowhani-Farid","year":"2023","unstructured":"Rowhani-Farid, A. et al. Clinical trial data sharing: A cross-sectional study of outcomes associated with two NIH models. Open Science Framework, https:\/\/doi.org\/10.17605\/OSF.IO\/T8B6G (2023)."},{"key":"2436_CR21","doi-asserted-by":"publisher","first-page":"k400","DOI":"10.1136\/bmj.k400","volume":"360","author":"F Naudet","year":"2018","unstructured":"Naudet, F. et al. Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in The BMJ and PLOS Medicine. BMJ 360, k400 (2018).","journal-title":"BMJ"},{"key":"2436_CR22","doi-asserted-by":"publisher","first-page":"e011784","DOI":"10.1136\/bmjopen-2016-011784","volume":"6","author":"A Rowhani-Farid","year":"2016","unstructured":"Rowhani-Farid, A. & Barnett, A. Has open data arrived at the British Medical Journal (BMJ)? An observational study. BMJ Open 6, e011784 (2016).","journal-title":"BMJ Open"},{"key":"2436_CR23","doi-asserted-by":"publisher","first-page":"e2325342","DOI":"10.1001\/jamanetworkopen.2023.25342","volume":"6","author":"C Narang","year":"2023","unstructured":"Narang, C., Ouvina, M., Rees, C. A. & Bourgeois, F. T. Data Sharing for Pediatric Clinical Trials Funded by the US National Institutes of Health. JAMA Netw Open 6, e2325342 (2023).","journal-title":"JAMA Netw Open"}],"container-title":["Scientific Data"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41597-023-02436-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41597-023-02436-0","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41597-023-02436-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,20]],"date-time":"2023-11-20T12:08:42Z","timestamp":1700482122000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41597-023-02436-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,8]]},"references-count":23,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["2436"],"URL":"https:\/\/doi.org\/10.1038\/s41597-023-02436-0","relation":{"references":[{"id-type":"uri","id":"https:\/\/www.cancer.gov\/news-events\/cancer-currents-blog\/2017\/nctn-ncorp-data-archive","asserted-by":"subject"},{"id-type":"uri","id":"","asserted-by":"subject"}]},"ISSN":["2052-4463"],"issn-type":[{"value":"2052-4463","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,8]]},"assertion":[{"value":"30 September 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 August 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 August 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"When this work was conducted, the salary of A.R.F. was supported by the RIAT Support Center at the University of Maryland. The RIAT Support Center was supported by the Laura and John Arnold Foundation. A.D.Z. currently receives research support from the National Institutes of Aging through the Duke Creating ADRD Researchers for the Next Generation\u2014Stimulating Access to Research in Residency (CARiNG-StARR) programme (R38AG065762). C.P.G. has received research funding, though Yale, from the NCCN Foundation (Astra-Zeneca) and Genentech, as well as funding from Johnson and Johnson to help devise and implement new approaches to sharing clinical trial data. H.M.K. received expenses and\/or personal fees from UnitedHealth, IBM Watson Health, Element Science, Aetna, Facebook, the Siegfried and Jensen Law Firm, Arnold and Porter Law Firm, Martin\/Baughman Law Firm, F-Prime, and the National Center for Cardiovascular Diseases in Beijing. He is an owner of Refactor Health and HugoHealth, and had grants and\/or contracts from the Centers for Medicare & Medicaid Services, Medtronic, the U.S. Food and Drug Administration, Johnson & Johnson, the Foundation for a Smoke-Free World, the State of Connecticut Department of Public Health, and the Shenzhen Center for Health Information. J.S.R. currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from Arnold Ventures; in addition, J.S.R. was an expert witness at the request of Relator\u2019s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled September 2022. M.G., S.S. and A.O.E. have no competing interests to declare.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"529"}}