Skip to main content
Top
Published in: Netherlands Heart Journal 5/2017

Open Access 01-05-2017 | Special Article

Data sharing: A new editorial initiative of the International Committee of Medical Journal Editors

Implications for the Editors’ Network

Author: F. Alfonso

Published in: Netherlands Heart Journal | Issue 5/2017

Login to get access

Abstract

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship – emphasising the importance of responsibility and accountability – have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors’ Network of the European Society of Cardiology.
Appendix
Available only for authorised users
Literature
1.
go back to reference Alfonso F, Ambrosio G, Pinto FJ, et al. European national society cardiovascular journals. Background, rationale and mission statement of the ‘editors’ club. Rev Esp Cardiol. 2008;61:644–50.CrossRefPubMed Alfonso F, Ambrosio G, Pinto FJ, et al. European national society cardiovascular journals. Background, rationale and mission statement of the ‘editors’ club. Rev Esp Cardiol. 2008;61:644–50.CrossRefPubMed
2.
go back to reference Network ESC task force. European society of cardiology national cardiovascular journals: the ’editors’ network. Eur Heart J. 2010;31:26–8. Network ESC task force. European society of cardiology national cardiovascular journals: the ’editors’ network. Eur Heart J. 2010;31:26–8.
3.
go back to reference Mills P, Timmis A, Huber K, et al. The role of European national journals in education. Heart. 2009;95:e3.CrossRefPubMed Mills P, Timmis A, Huber K, et al. The role of European national journals in education. Heart. 2009;95:e3.CrossRefPubMed
4.
go back to reference Alfonso F. The editors’ network of the european society of cardiology. Eur Heart J. 2011;32:919–21. Alfonso F. The editors’ network of the european society of cardiology. Eur Heart J. 2011;32:919–21.
5.
go back to reference International Committee of Medical Journals Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Updated December 2015. http://www.icmje.org. International Committee of Medical Journals Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Updated December 2015. http://​www.​icmje.​org.
7.
go back to reference World Association of Medical Editors. WAME Professionalism Code of Conduct The new WAME Professionalism Code of Conduct for medical journal editors. http://www.wame.org. World Association of Medical Editors. WAME Professionalism Code of Conduct The new WAME Professionalism Code of Conduct for medical journal editors. http://​www.​wame.​org.
9.
go back to reference International Committee of Medical Journal Editors, De Angelis CD, Drazen JM, Frizelle FA, et al. Is this clinical trial fully registered? – A statement from the International Committee of Medical Journal Editors. N Engl J Med. 2005;352:2436–8.CrossRef International Committee of Medical Journal Editors, De Angelis CD, Drazen JM, Frizelle FA, et al. Is this clinical trial fully registered? – A statement from the International Committee of Medical Journal Editors. N Engl J Med. 2005;352:2436–8.CrossRef
10.
go back to reference Alfonso F, Segovia J, Heras M, Bermejo J. Publication of clinical trials in scientific journals: editorial issues. Rev Esp Cardiol. 2006;59:1206–14.CrossRefPubMed Alfonso F, Segovia J, Heras M, Bermejo J. Publication of clinical trials in scientific journals: editorial issues. Rev Esp Cardiol. 2006;59:1206–14.CrossRefPubMed
11.
go back to reference Drazen JM, Van der Weyden MB, Sahni P, et al. Uniform format for disclosure of competing interests in ICMJE journals. N Engl J Med. 2009;361:1896–7.CrossRefPubMed Drazen JM, Van der Weyden MB, Sahni P, et al. Uniform format for disclosure of competing interests in ICMJE journals. N Engl J Med. 2009;361:1896–7.CrossRefPubMed
12.
go back to reference Network European Society of Cardiology Task Force. Conflict of interest policies and disclosure requirements among European Society of Cardiology National Cardiovascular Journals. Eur Heart J. 2012;33:587–94.CrossRef Network European Society of Cardiology Task Force. Conflict of interest policies and disclosure requirements among European Society of Cardiology National Cardiovascular Journals. Eur Heart J. 2012;33:587–94.CrossRef
13.
go back to reference Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship, authorship, and accountability. N Engl J Med. 2001;345:825–6.CrossRefPubMed Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship, authorship, and accountability. N Engl J Med. 2001;345:825–6.CrossRefPubMed
14.
go back to reference Taichman DB, Backus J, Baethge C, et al. Sharing clinical trial data – a proposal from the international committee of medical journal editors. N Engl J Med. 2016;374:384–6.CrossRefPubMed Taichman DB, Backus J, Baethge C, et al. Sharing clinical trial data – a proposal from the international committee of medical journal editors. N Engl J Med. 2016;374:384–6.CrossRefPubMed
15.
go back to reference Merson L, Gaye O, Guerin PJ. Avoiding data dumpsters – toward equitable and useful data sharing. N Engl J Med. 2016;374:2414–5.CrossRefPubMed Merson L, Gaye O, Guerin PJ. Avoiding data dumpsters – toward equitable and useful data sharing. N Engl J Med. 2016;374:2414–5.CrossRefPubMed
16.
go back to reference Krumholz HM, Waldstreicher J. The Yale Open Data Access (YODA) project – a mechanism for data sharing. N Engl J Med. 2016;375:403–5.CrossRefPubMed Krumholz HM, Waldstreicher J. The Yale Open Data Access (YODA) project – a mechanism for data sharing. N Engl J Med. 2016;375:403–5.CrossRefPubMed
18.
go back to reference Kavsak PA. The International Committee of Medical Journal Editors proposal for sharing clinical trial data and the possible implications for the peer review process. Ann Transl Med. 2016;4:115.CrossRefPubMedPubMedCentral Kavsak PA. The International Committee of Medical Journal Editors proposal for sharing clinical trial data and the possible implications for the peer review process. Ann Transl Med. 2016;4:115.CrossRefPubMedPubMedCentral
20.
go back to reference Institute of Medicine. Sharing clinical trial data: maximizing benefits, minimizing risk. Washington, DC: The National Academies Press; 2015. Institute of Medicine. Sharing clinical trial data: maximizing benefits, minimizing risk. Washington, DC: The National Academies Press; 2015.
21.
go back to reference Vallance P, Freeman A, Stewart M. Data sharing as part of the normal scientific process: a view from the pharmaceutical industry. Plos Med. 2016;13:e1001936.CrossRefPubMedPubMedCentral Vallance P, Freeman A, Stewart M. Data sharing as part of the normal scientific process: a view from the pharmaceutical industry. Plos Med. 2016;13:e1001936.CrossRefPubMedPubMedCentral
23.
go back to reference Modjarrad K, Moorthy VS, Millet P, Gsell P‑S, Roth C, Kieny M‑P. Developing global norms for sharing data and results during public health emergencies. Plos Med. 2015;13:e1001935.CrossRef Modjarrad K, Moorthy VS, Millet P, Gsell P‑S, Roth C, Kieny M‑P. Developing global norms for sharing data and results during public health emergencies. Plos Med. 2015;13:e1001935.CrossRef
24.
25.
27.
go back to reference Sudlow R, Branson J, Friede T, Morgan D, Whately-Smith C. EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets – a primer for academic researchers. BMC Med Res Methodol. 2016;16(Suppl 1):73.CrossRefPubMedPubMedCentral Sudlow R, Branson J, Friede T, Morgan D, Whately-Smith C. EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets – a primer for academic researchers. BMC Med Res Methodol. 2016;16(Suppl 1):73.CrossRefPubMedPubMedCentral
29.
go back to reference Hopkins C, Sydes M, Murray G, et al. UK publicly funded clinical trials units supported a controlled access approach to share individual participant data but highlighted concerns. J Clin Epidemiol. 2016;70:17–25.CrossRefPubMedPubMedCentral Hopkins C, Sydes M, Murray G, et al. UK publicly funded clinical trials units supported a controlled access approach to share individual participant data but highlighted concerns. J Clin Epidemiol. 2016;70:17–25.CrossRefPubMedPubMedCentral
30.
31.
32.
go back to reference Academic Research Organization Consortium for Continuing Evaluation of Scientific Studies – Cardiovascular (ACCESS CV). Sharing data from cardiovascular clinical trials – a proposal. N Engl J Med. 2016;375:407–9.CrossRef Academic Research Organization Consortium for Continuing Evaluation of Scientific Studies – Cardiovascular (ACCESS CV). Sharing data from cardiovascular clinical trials – a proposal. N Engl J Med. 2016;375:407–9.CrossRef
33.
go back to reference Fletcher C, Hollis S, Burger HU, Gerlinger C. Statistical guidance for responsible data sharing: an overview. BMC Med Res Methodol. 2016;16(Suppl 1):74.CrossRefPubMedPubMedCentral Fletcher C, Hollis S, Burger HU, Gerlinger C. Statistical guidance for responsible data sharing: an overview. BMC Med Res Methodol. 2016;16(Suppl 1):74.CrossRefPubMedPubMedCentral
34.
go back to reference Tucker K, Branson J, Dilleen M, et al. Protecting patient privacy when sharing patient-level data from clinical trials. BMC Med Res Methodol. 2016;16(Suppl 1):77.CrossRefPubMedPubMedCentral Tucker K, Branson J, Dilleen M, et al. Protecting patient privacy when sharing patient-level data from clinical trials. BMC Med Res Methodol. 2016;16(Suppl 1):77.CrossRefPubMedPubMedCentral
35.
go back to reference International Consortium of Investigators for Fairness in Trial Data Sharing, Devereaux PJ, Guyatt G, Gerstein H, Connolly S, Yusuf S. Toward fairness in data sharing. N Engl J Med. 2016;375:405–7.CrossRef International Consortium of Investigators for Fairness in Trial Data Sharing, Devereaux PJ, Guyatt G, Gerstein H, Connolly S, Yusuf S. Toward fairness in data sharing. N Engl J Med. 2016;375:405–7.CrossRef
36.
37.
go back to reference Strom BL, Buyse M, Hughes J, Knoppers BM. Data sharing, year 1 – access to data from industry-sponsored clinical trials. N Engl J Med. 2014;371:2052–4.CrossRefPubMed Strom BL, Buyse M, Hughes J, Knoppers BM. Data sharing, year 1 – access to data from industry-sponsored clinical trials. N Engl J Med. 2014;371:2052–4.CrossRefPubMed
38.
go back to reference Navar AM, Pencina MJ, Rymer JA, Louzao DM, Peterson ED. Use of open access platforms for clinical trial data. JAMA. 2016;315:1283–4.CrossRefPubMed Navar AM, Pencina MJ, Rymer JA, Louzao DM, Peterson ED. Use of open access platforms for clinical trial data. JAMA. 2016;315:1283–4.CrossRefPubMed
39.
go back to reference Gonçalves LM, Seabra-Gomes R. Celebrating the 10th anniversary of the portuguese cardiology data collection center: a reflexion on its past, present, and future. Rev Port Cardiol. 2012;31:763–8.PubMed Gonçalves LM, Seabra-Gomes R. Celebrating the 10th anniversary of the portuguese cardiology data collection center: a reflexion on its past, present, and future. Rev Port Cardiol. 2012;31:763–8.PubMed
40.
Metadata
Title
Data sharing: A new editorial initiative of the International Committee of Medical Journal Editors
Implications for the Editors’ Network
Author
F. Alfonso
Publication date
01-05-2017
Publisher
Bohn Stafleu van Loghum
Published in
Netherlands Heart Journal / Issue 5/2017
Print ISSN: 1568-5888
Electronic ISSN: 1876-6250
DOI
https://doi.org/10.1007/s12471-017-0974-3

Other articles of this Issue 5/2017

Netherlands Heart Journal 5/2017 Go to the issue