Korean Circ J.  2017 May;47(3):307-313. 10.4070/kcj.2016.0444.

Data Sharing: a New Editorial Initiative from the International Committee of Medical Journal Editors. Implications for the Editors' Network

• Alfonso F
• Editors' Network European Society of Cardiology Task Force

• KMID: 2385382
• DOI: http://doi.org/10.4070/kcj.2016.0444

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-emphasizing the importance of responsibility and accountability-, have been proposed. This year a new editorial initiative to foster sharing of clinical trial data has been launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and Editors of the Editors' Network of the European Society of Cardiology.

Keyword

Editorial ethics; Scientific process; Data sharing; Clinical trial; Trial registration; Authorship; Conflict of interest; Big-data; Scientific Journals

MeSH Terms

Authorship
Cardiology
Conflict of Interest
Disclosure
Humans
Information Dissemination*
Research Personnel

Reference

1. 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; 61:644–650. PMID: 18570788.

2. Alfonso F, Ambrosio G, Pinto FJ, et al. European Society of Cardiology National Cardiovascular Journals: the ‘Editors’ Network’. Eur Heart J. 2010; 31:26–28. PMID: 19952007.

3. Mills P, Timmis A, Huber K, et al. The role of European national Journals in Education. Heart. 2009; 95:e3. PMID: 19946003.

4. Alfonso F. The Editors’ Network of the European Society of Cardiology. Eur Heart J. 2011; 32:919–921.

5. International Committee of Medical Journals Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Updated December 2015. Available: http://www.icmje.org.

6. Council of Science Editors. White Paper on Publication Ethics. CSE's White Paper on Promoting Integrity in Scientific Journal Publications. Updated 2012. Available: http://www.CouncilScienceEditors.org.

7. World Association of Medical Editors. WAME Professionalism Code of Conduct The new WAME Professionalism Code of Conduct for medical journal editors. Available: http://www.wame.org.

8. Committee On Publication Ethics, COPE. Code of Conduct and Best Practice Guidelines for Journal Editors. Available: http://publicationethics.org/resources/guidelines.

9. 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; 352:2436–2438. PMID: 15911780.

10. Alfonso F, Segovia J, Heras M, Bermejo J. Publication of clinical trials in scientific journals: Editorial issues. Rev Esp Cardiol. 2006; 59:1206–1214. PMID: 17697666.

11. 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; 361:1896–1897. PMID: 19825973.

12. Alfonso F, Timmis A, Pinto FJ, et al. Conflict of interest policies and disclosure requirements among European Society of Cardiology National Cardiovascular Journals. Eur Heart J. 2012; 33:587–594. PMID: 22383145.

13. Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship, authorship, and accountability. N Engl J Med. 2001; 345:825–826. PMID: 11556304.

14. 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; 374:384–386. PMID: 26786954.

15. Merson L, Gaye O, Guerin PJ. Avoiding Data Dumpsters--Toward Equitable and Useful Data Sharing. N Engl J Med. 2016; 374:2414–2415. PMID: 27168351.

16. Krumholz HM, Waldstreicher J. The Yale Open Data Access (YODA) Project--A Mechanism for Data Sharing. N Engl J Med. 2016; 375:403–405. PMID: 27518657.

17. Loder E, Groves T. The BMJ requires data sharing on request for all trials. BMJ. 2015; 350:h2373. DOI: 10.1136/bmj.h2373. PMID: 25953153.

18. 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. PMID: 27127768.

19. Manamley N, Mallett S, Sydes MR, et al. Data sharing and the evolving role of statisticians. BMC Med Res Methodol. 2016; 16(Suppl 1):75. PMID: 27410483.

20. Institute of Medicine. Sharing clinical trial data: maximizing benefits, minimizing risk. Washington, DC: The National Academies Press;2015.

21. 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. PMID: 26731493.

22. www.who.int/ictrp/results/WHO_Statement_results_reporting_clinical_trials.pdf?ua=1.

23. 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. 2016; 13:e1001935. PMID: 26731342.

24. Coady SA, Wagner E. Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI. Trials. 2013; 14:201. PMID: 23837497.

25. Geifman N, Bollyky J, Bhattacharya S, Butte AJ. Opening clinical trial data: are the voluntary data-sharing portals enough? BMC Med. 2015; 13:280. PMID: 26560699.

26. Van Tuyl S, Whitmire AL. Water, Water, Everywhere: Defining and Assessing Data Sharing in Academia. PLoS One. 2016; 11:e0147942. PMID: 26886581.

27. 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. PMID: 27410386.

28. Drazen JM. Data Sharing and the Journal. N Engl J Med. 2016; 374:e24. DOI: 10.1056/NEJMe1601087. PMID: 26808582.

29. 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. PMID: 26169841.

30. Lo B. Sharing clinical trial data: maximizing benefits, minimizing risk. JAMA. 2015; 313:793–794. PMID: 25594500.

31. Ross JS, Krumholz HM. Open Access Platforms for Sharing Clinical Trial Data. JAMA. 2016; 316:666.

32. 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; 375:407–409. PMID: 27518659.

33. 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. PMID: 27409824.

34. 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. PMID: 27410040.

35. 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; 375:405–407. PMID: 27518658.

36. Hayes R, Ayles H, Binka F, Cowan F, Kamali A, Kapiga S, Kleinschmidt I, Mayaud P, Patel V, Smith P, Weiss H. Sharing clinical trial data. Lancet. 2016; 387:2287.

37. 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; 371:2052–2054. PMID: 25317745.

38. Navar AM, Pencina MJ, Rymer JA, Louzao DM, Peterson ED. Use of open access platforms for clinical trial data. JAMA. 2016; 315:1283–1284. PMID: 27002452.

39. 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; 31:763–768. PMID: 23158963.

40. Horton R. Offline: Data sharing why editors may have got it wrong. Lancet. 2016; 388:1143. PMID: 27650083.