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

BMC Medicine

Volumn 12, Issue 1, 2014, Pages

  Marušic, Ana ^a   Hren, Darko ^b   Mansi, Bernadette ^c,d   Lineberry, Neil ^d,e   Bhattacharya, Ananya ^d,f   Garrity, Maureen ^d,g   Clark, Juli ^d,h   Gesell, Thomas ^d,i   Glasser, Susan ^d,j   Gonzalez, John ^d,k   Hustad, Carolyn ^d,l   Lannon, Mary Margaret ^d,m   Mooney, LaVerne A ^d,n   Peña, Teresa ^d,k  

^a UNIVERSITY OF SPLIT   (Croatia)

^b UNIVERSITY OF SPLIT   (Croatia)

^c GLAXOSMITHKLINE   (United States)

^d Member of MPIP Initiative Steering Committee   (United States)

^e Navigant Consulting   (United States)

^f BRISTOL MYERS SQUIBB   (United States)

^g Astellas   (United States)

^h AMGEN INC   (United States)

ⁱ International Society for Medical Publication Professionals   (United States)

^j JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^k ASTRAZENECA   (United Kingdom)

^l MERCK RESEARCH LABORATORIES   (United States)

^m Takeda Pharmaceuticals   (United States)

ⁿ PFIZER INC   (United States)

more..

Author keywords

Authorship; Clinical investigators; Clinical trial; Journal editors; Medical writers; MPIP Initiative; Publication professionals; Transparency

Indexed keywords

BIOMED CENTRAL; CLINICAL TRIAL; EDITOR; HUMAN; MEDICAL RESEARCH; PUBLISHING; WRITING; CLINICAL TRIAL (TOPIC); CONFLICT OF INTEREST; DECISION MAKING; DRUG INDUSTRY; ECONOMICS; ETHICS; FINANCIAL MANAGEMENT; INTERPERSONAL COMMUNICATION; MEDICAL ETHICS; PRACTICE GUIDELINE; PUBLICATION; STANDARDS;

AUTHORSHIP; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; CONFLICT OF INTEREST; DECISION MAKING; DISCLOSURE; DRUG INDUSTRY; ETHICS, PROFESSIONAL; FINANCIAL SUPPORT; HUMANS; PRACTICE GUIDELINES AS TOPIC; PUBLICATIONS;

EID: 84965087226     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/s12916-014-0197-z     Document Type: Article

References (28)

1. 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.
2. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Updated 2013. [http://www.icmje. org/recommendations/archives/2013_aug_urm.pdf]
3. Wager E: Do medical journals provide clear and consistent guidelines on authorship? MedGenMed 2007, 9:16.
4. 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.
5. Rennie D, Yank V, Emanuel L: When authorship fails. A proposal to make contributors accountable. JAMA 1997, 278:579-585.
6. Laine C, Mulrow CD: Exorcising ghosts and unwelcome guests. Ann Intern Med 2005, 143:611-612.
7. Gøtzsche PC, Hrobjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW: Ghost authorship in industry-initiated randomised trials. PLoS Med 2007, 4:e19.
8. 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.
9. Barbour V: How ghost-writing threatens the credibility of medical knowledge and medical journals. Hematologica 2010, 95:1-2.
10. Matheson A: How industry uses the ICMJE guidelines to manipulate authorship-and how they should be revised. PLoS Med 2011, 8:e1001072.
11. 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.
12. 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.
13. Getz K, Campo R: Drug development study designs have reached the danger zone. Expert Rev Clin Pharmacol 2013, 6:589-591.
14. 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.
15. 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.
16. Thomas DR: A general inductive approach for analyzing qualitative evaluation data. Am J Eval 2006, 27:237-246.
17. Saldaña J: The Coding Manual for Qualitative Researchers. Los Angeles: Sage 2009.
18. 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, International Society for Medical Publication Professionals: Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ 2009, 339:b4330.
19. 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.
20. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Updated 2008 [http://www.icmje.org/recommendations/archives/2008_urm.pdf]
21. 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.
22. Kmietoxicz Z: Transparency campaigners welcome new rules for clinical trials in Europe. BMJ 2014, 348:g2579.
23. All Trials [http://www.alltrials.net/]
24. Chan AW, Tetzlaff J, Altman D, Laupacis A, Gøtzsche P, Krleža-Jeric 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.
25. 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.
26. Turiel E: The Development of Social Knowledge: Morality and Convention. New York: Cambridge University Press; 1983.
27. 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.
28. Gobo G: Re-Conceptualizing Generalization: old Issues in a New Frame. In The SAGE Handbook of Social Research Methods. Edited by Brannen J. London: Sage 2008:193-213.