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Published in: BMC Medicine 1/2014

Open Access 01-12-2014 | Correspondence

Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications

Authors: Ana Maruš.ić, Darko Hren, Bernadette Mansi, Neil Lineberry, Ananya Bhattacharya, Maureen Garrity, Juli Clark, Thomas Gesell, Susan Glasser, John Gonzalez, Carolyn Hustad, Mary-Margaret Lannon, LaVerne A Mooney, Teresa Peña

Published in: BMC Medicine | Issue 1/2014

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Abstract

Authorship guidelines have established criteria to guide author selection based on significance of contribution and helped to define associated responsibilities and accountabilities for the published findings. However, low awareness, variable interpretation, and inconsistent application of these guidelines can lead to confusion and a lack of transparency when recognizing those who merit authorship. This article describes a research project led by the Medical Publishing Insights and Practices (MPIP) Initiative to identify current challenges when determining authorship for industry-sponsored clinical trials and develop an improved approach to facilitate decision-making when recognizing authors from related publications. A total of 498 clinical investigators, journal editors, publication professionals and medical writers were surveyed to understand better how they would adjudicate challenging, real-world authorship case scenarios, determine the perceived frequency of each scenario and rate their confidence in the responses provided. Multiple rounds of discussions about these results with journal editors, clinical investigators and industry representatives led to the development of key recommendations intended to enhance transparency when determining authorship. These included forming a representative group to establish authorship criteria early in a trial, having all trial contributors agree to these criteria and documenting trial contributions to objectively determine who warrants an invitation to participate in the manuscript development process. The resulting Five-step Authorship Framework is designed to create a more standardized approach when determining authorship for clinical trial publications. Overall, these recommendations aim to facilitate more transparent authorship decisions and help readers better assess the credibility of results and perspectives of the authors for medical research more broadly.
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Literature
1.
go back to reference Kesselheim AS, Robertson CT, Myers JA, Rose SL, Gillet V, Ross KM, Glynn RJ, Joffe S, Avorn J: A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012, 367: 1119-1127. 10.1056/NEJMsa1202397.CrossRefPubMedPubMedCentral Kesselheim AS, Robertson CT, Myers JA, Rose SL, Gillet V, Ross KM, Glynn RJ, Joffe S, Avorn J: A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012, 367: 1119-1127. 10.1056/NEJMsa1202397.CrossRefPubMedPubMedCentral
4.
go back to reference Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, Lundberg GD, Rennie D: Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA. 1998, 280: 222-224. 10.1001/jama.280.3.222.CrossRefPubMed Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, Lundberg GD, Rennie D: Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA. 1998, 280: 222-224. 10.1001/jama.280.3.222.CrossRefPubMed
5.
go back to reference Rennie D, Yank V, Emanuel L: When authorship fails. A proposal to make contributors accountable. JAMA. 1997, 278: 579-585. 10.1001/jama.1997.03550070071041.CrossRefPubMed Rennie D, Yank V, Emanuel L: When authorship fails. A proposal to make contributors accountable. JAMA. 1997, 278: 579-585. 10.1001/jama.1997.03550070071041.CrossRefPubMed
6.
go back to reference Laine C, Mulrow CD: Exorcising ghosts and unwelcome guests. Ann Intern Med. 2005, 143: 611-612. 10.7326/0003-4819-143-8-200510180-00013.CrossRefPubMed Laine C, Mulrow CD: Exorcising ghosts and unwelcome guests. Ann Intern Med. 2005, 143: 611-612. 10.7326/0003-4819-143-8-200510180-00013.CrossRefPubMed
7.
go back to reference Gøtzsche PC, Hrobjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW: Ghost authorship in industry-initiated randomised trials. PLoS Med. 2007, 4: e19-10.1371/journal.pmed.0040019.CrossRefPubMedPubMedCentral Gøtzsche PC, Hrobjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW: Ghost authorship in industry-initiated randomised trials. PLoS Med. 2007, 4: e19-10.1371/journal.pmed.0040019.CrossRefPubMedPubMedCentral
8.
go back to reference Wislar JS, Flanagin A, Fontanarosa PB, Deangelis CD: Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ. 2011, 343: d6128-10.1136/bmj.d6128.CrossRefPubMedPubMedCentral Wislar JS, Flanagin A, Fontanarosa PB, Deangelis CD: Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ. 2011, 343: d6128-10.1136/bmj.d6128.CrossRefPubMedPubMedCentral
9.
go back to reference Barbour V: How ghost-writing threatens the credibility of medical knowledge and medical journals. Hematologica. 2010, 95: 1-2. 10.3324/haematol.2009.017426.CrossRef Barbour V: How ghost-writing threatens the credibility of medical knowledge and medical journals. Hematologica. 2010, 95: 1-2. 10.3324/haematol.2009.017426.CrossRef
10.
go back to reference Matheson A: How industry uses the ICMJE guidelines to manipulate authorship-and how they should be revised. PLoS Med. 2011, 8: e1001072-10.1371/journal.pmed.1001072.CrossRefPubMedPubMedCentral Matheson A: How industry uses the ICMJE guidelines to manipulate authorship-and how they should be revised. PLoS Med. 2011, 8: e1001072-10.1371/journal.pmed.1001072.CrossRefPubMedPubMedCentral
11.
go back to reference Marusic A, Bosnjak L, Jeroncic A: A systematic review of research on the meaning, ethics and practices of authorship across scholarly disciplines. PLoS One. 2011, 6: e23477-10.1371/journal.pone.0023477.CrossRefPubMedPubMedCentral Marusic A, Bosnjak L, Jeroncic A: A systematic review of research on the meaning, ethics and practices of authorship across scholarly disciplines. PLoS One. 2011, 6: e23477-10.1371/journal.pone.0023477.CrossRefPubMedPubMedCentral
12.
go back to reference Getz K, Wenger J, Campo R, Seguine E, Kaitin K: Assessing the impact of protocol design change on clinical trial performance. Am J Ther. 2008, 15: 450-457. 10.1097/MJT.0b013e31816b9027.CrossRefPubMed Getz K, Wenger J, Campo R, Seguine E, Kaitin K: Assessing the impact of protocol design change on clinical trial performance. Am J Ther. 2008, 15: 450-457. 10.1097/MJT.0b013e31816b9027.CrossRefPubMed
13.
go back to reference Getz K, Campo R: Drug development study designs have reached the danger zone. Expert Rev Clin Pharmacol. 2013, 6: 589-591. 10.1586/17512433.2013.841539.CrossRefPubMed Getz K, Campo R: Drug development study designs have reached the danger zone. Expert Rev Clin Pharmacol. 2013, 6: 589-591. 10.1586/17512433.2013.841539.CrossRefPubMed
14.
go back to reference Mansi BA, Clark J, David FS, Gesell TM, Glasser S, Gonzalez J, Haller DG, Laine C, Miller CL, Mooney LA, Zecevic M: Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012, 87: 424-429. 10.1016/j.mayocp.2012.02.009.CrossRefPubMedPubMedCentral Mansi BA, Clark J, David FS, Gesell TM, Glasser S, Gonzalez J, Haller DG, Laine C, Miller CL, Mooney LA, Zecevic M: Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012, 87: 424-429. 10.1016/j.mayocp.2012.02.009.CrossRefPubMedPubMedCentral
15.
go back to reference Clark J, Gonzalez J, Mansi B, Miller C, Mooney LA, Mosdell K, Richards D, Schreiweis M, Weigel A, Wager E: Enhancing transparency and efficiency in reporting industry-sponsored clinical research: report from the Medical Publishing Insights and Practices Initiative. Int J Clin Pract. 2010, 64: 1028-1033. 10.1111/j.1742-1241.2010.02416.x.CrossRefPubMed Clark J, Gonzalez J, Mansi B, Miller C, Mooney LA, Mosdell K, Richards D, Schreiweis M, Weigel A, Wager E: Enhancing transparency and efficiency in reporting industry-sponsored clinical research: report from the Medical Publishing Insights and Practices Initiative. Int J Clin Pract. 2010, 64: 1028-1033. 10.1111/j.1742-1241.2010.02416.x.CrossRefPubMed
16.
go back to reference Thomas DR: A general inductive approach for analyzing qualitative evaluation data. Am J Eval. 2006, 27: 237-246. 10.1177/1098214005283748.CrossRef Thomas DR: A general inductive approach for analyzing qualitative evaluation data. Am J Eval. 2006, 27: 237-246. 10.1177/1098214005283748.CrossRef
17.
go back to reference Saldaña J: The Coding Manual for Qualitative Researchers. 2009, Sage, Los Angeles Saldaña J: The Coding Manual for Qualitative Researchers. 2009, Sage, Los Angeles
18.
go back to reference Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM, Ellison JM, Field EA, Gurr JA, Marx ME, Patel M, Sanes-Miller C, Yarker YE: Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009, 339: b4330-10.1136/bmj.b4330.CrossRefPubMed Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM, Ellison JM, Field EA, Gurr JA, Marx ME, Patel M, Sanes-Miller C, Yarker YE: Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009, 339: b4330-10.1136/bmj.b4330.CrossRefPubMed
19.
go back to reference Wager E, Woolley K, Adshead V, Cairns A, Fullam J, Gonzalez J, Grant T, Tortell S: Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014, 4: e004780-10.1136/bmjopen-2013-004780.CrossRefPubMedPubMedCentral Wager E, Woolley K, Adshead V, Cairns A, Fullam J, Gonzalez J, Grant T, Tortell S: Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014, 4: e004780-10.1136/bmjopen-2013-004780.CrossRefPubMedPubMedCentral
21.
go back to reference Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF: Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013, 347: f6104-10.1136/bmj.f6104.CrossRefPubMedPubMedCentral Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF: Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013, 347: f6104-10.1136/bmj.f6104.CrossRefPubMedPubMedCentral
22.
go back to reference Kmietoxicz Z: Transparency campaigners welcome new rules for clinical trials in Europe. BMJ. 2014, 348: g2579-10.1136/bmj.g2579.CrossRef Kmietoxicz Z: Transparency campaigners welcome new rules for clinical trials in Europe. BMJ. 2014, 348: g2579-10.1136/bmj.g2579.CrossRef
24.
go back to reference Chan AW, Tetzlaff J, Altman D, Laupacis A, Gøtzsche P, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D: SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013, 158: 200-207. 10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMed Chan AW, Tetzlaff J, Altman D, Laupacis A, Gøtzsche P, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D: SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013, 158: 200-207. 10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMed
25.
go back to reference Hren D, Sambunjak D, Marusic M, Marusic A: Medical students’ decisions about authorship in disputable situations: intervention study. Sci Eng Ethics. 2013, 19: 641-651. 10.1007/s11948-012-9358-7.CrossRefPubMed Hren D, Sambunjak D, Marusic M, Marusic A: Medical students’ decisions about authorship in disputable situations: intervention study. Sci Eng Ethics. 2013, 19: 641-651. 10.1007/s11948-012-9358-7.CrossRefPubMed
26.
go back to reference Turiel E: The Development of Social Knowledge: Morality and Convention. 1983, Cambridge University Press, New York Turiel E: The Development of Social Knowledge: Morality and Convention. 1983, Cambridge University Press, New York
27.
go back to reference Braithwaite D, Emery J, de Lusignan S, Sutton S: Using the Internet to conduct surveys of health professionals: a valid alternative?. Fam Pract. 2003, 20: 545-551. 10.1093/fampra/cmg509.CrossRefPubMed Braithwaite D, Emery J, de Lusignan S, Sutton S: Using the Internet to conduct surveys of health professionals: a valid alternative?. Fam Pract. 2003, 20: 545-551. 10.1093/fampra/cmg509.CrossRefPubMed
28.
go back to reference Gobo G: Re-Conceptualizing Generalization: old Issues in a New Frame. The SAGE Handbook of Social Research Methods. Edited by: Brannen J. 2008, Sage, London, 193-213. 10.4135/9781446212165.n12.CrossRef Gobo G: Re-Conceptualizing Generalization: old Issues in a New Frame. The SAGE Handbook of Social Research Methods. Edited by: Brannen J. 2008, Sage, London, 193-213. 10.4135/9781446212165.n12.CrossRef
Metadata
Title
Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications
Authors
Ana Maruš.ić
Darko Hren
Bernadette Mansi
Neil Lineberry
Ananya Bhattacharya
Maureen Garrity
Juli Clark
Thomas Gesell
Susan Glasser
John Gonzalez
Carolyn Hustad
Mary-Margaret Lannon
LaVerne A Mooney
Teresa Peña
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Medicine / Issue 1/2014
Electronic ISSN: 1741-7015
DOI
https://doi.org/10.1186/s12916-014-0197-z

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