Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials


In a document analysis of trial protocols and publications, Erik von Elm and colleagues investigate the potential impact of publication agreements between industry sponsors and academic investigators.


Vyšlo v časopise: Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PLoS Med 13(6): e32767. doi:10.1371/journal.pmed.1002046
Kategorie: Research Article
prolekare.web.journal.doi_sk: 10.1371/journal.pmed.1002046

Souhrn

In a document analysis of trial protocols and publications, Erik von Elm and colleagues investigate the potential impact of publication agreements between industry sponsors and academic investigators.


Zdroje

1. Chan A-W, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457–2465. doi: 10.1001/jama.291.20.2457 15161896

2. Kasenda B, von Elm E, You J, Blümle A, Tomonaga Y, Saccilotto R, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA. 2014;311:1045–1051. doi: 10.1001/jama.2014.1361 24618966

3. 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. doi: 10.1136/bmj.f6104 24169943

4. Drazen JM. Institutions, contracts, and academic freedom. N Engl J Med. 2002;347:1362–1363. doi: 10.1056/NEJMe020122 12397197

5. Bodenheimer T. Uneasy alliance—clinical investigators and the pharmaceutical industry. N Engl J Med. 2000;342:1539–1544. doi: 10.1056/NEJM200005183422024 10816196

6. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med. 2005;2:e138. doi: 10.1371/journal.pmed.0020138 15916457

7. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009;361:1963–1971. doi: 10.1056/NEJMsa0906126 19907043

8. Vedula SS, Goldman PS, Rona IJ, Greene TM, Dickersin K. Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin litigation. Trials. 2012;13:136. doi: 10.1186/1745-6215-13-136 22888801

9. Smyth RMD, Kirkham JJ, Jacoby A, Altman DG, Gamble C, Williamson PR. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ. 2011;342:c7153. doi: 10.1136/bmj.c7153 21212122

10. Chan A-W, Krleza-Jerić K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ. 2004;171:735–740. doi: 10.1503/cmaj.1041086 15451835

11. Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2008;5:e217. doi: 10.1371/journal.pmed.0050217 19067477

12. DeAngelis CD. Reporting financial conflicts of interest and relationships between investigators and research sponsors. JAMA. 2001;286:89. doi: 10.1001/jama.286.1.89 11434832

13. Davidoff F, DeAngelis CD, Drazen JM, Nicholls MG, Hoey J, Højgaard L, et al. Sponsorship, authorship, and accountability. N Engl J Med. 2001;345:825–827. doi: 10.1056/NEJMed010093 11556304

14. The Lancet. Statements, permissions, and signatures. 2016 [cited 13 Feb 2016]. Available: http://www.thelancet.com/lancet/information-for-authors/statements-permissions-signatures.

15. The New England Journal of Medicine. About NEJM—editorial policies. 2016 [cited 13 Feb 2016]. Available: http://www.nejm.org/page/about-nejm/editorial-policies.

16. PLoS Medicine. Submission guidelines. 2016 [cited 13 Feb 2016]. Available: http://journals.plos.org/plosmedicine/s/submission-guidelines.

17. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. 2015 Dec [cited 31 May 2016]. Available: http://icmje.org/icmje-recommendations.pdf.

18. Peddicord D, Covance, Icon Clinical Research, Inveresk Research Group, Kendle International, Parexel International, et al. Sponsorship, authorship, and accountability. N Engl J Med. 2002;346:290–292.

19. Mello MM, Clarridge BR, Studdert DM. Academic medical centers’ standards for clinical-trial agreements with industry. N Engl J Med. 2005;352:2202–2210. doi: 10.1056/NEJMsa044115 15917385

20. Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, et al. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med. 2002;347:1335–1341. doi: 10.1056/NEJMsa020349 12397192

21. Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Constraints on publication rights in industry-initiated clinical trials. JAMA. 2006;295:1645–1646. doi: 10.1001/jama.295.14.1645 16609085

22. Kasenda B, von Elm EB, You J, Blümle A, Tomonaga Y, Saccilotto R, et al. Learning from failure—rationale and design for a study about discontinuation of randomized trials (DISCO study). BMC Med Res Methodol. 2012;12:131. doi: 10.1186/1471-2288-12-131 22928744

23. Kasenda B. Data from: Agreements between industry and academia on publication rights: a retrospective study of protocols and publications of randomized clinical trials. Dryad Digital Repository. 2016.

24. Chan A-W, Upshur R, Singh JA, Ghersi D, Chapuis F, Altman DG. Research protocols: waiving confidentiality for the greater good. BMJ. 2006;332:1086–1089. 16675819

25. Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ, et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA. 2006;295:429–433. doi: 10.1001/jama.295.4.429 16434633

26. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA. 2010;303:2058–2064. doi: 10.1001/jama.2010.651 20501928

27. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA. 2008;299:1800–1812. doi: 10.1001/jama.299.15.1800 18413874

28. Nieto A, Mazon A, Pamies R, Linana JJ, Lanuza A, Jiménez FO, et al. Adverse effects of inhaled corticosteroids in funded and nonfunded studies. Arch Intern Med. 2007;167:2047–2053. doi: 10.1001/archinte.167.19.2047 17954797

29. Chan A-W, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586 23303884

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