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Publishing a Clinical Trial

  • Babak J. Orandi
  • Julie A. Freischlag
  • Mahmoud Malas
Chapter
Part of the Success in Academic Surgery book series (SIAS)

Abstract

Investigators have scientific, ethical, and personal reasons for publishing the results of their clinical trials. The conduct and analysis of the trial should be done in a transparent manner, and the outcomes/endpoints that were determined a priori must be reported, regardless of the results. The conduct and analysis of the trial should be done in a transparent manner and analyses should be done on the outcomes that were decided upon a priori. A number of resources and checklists are available for ensuring all of the necessary components of the write-up are included in the manuscript. The trial results should be published, irrespective of the findings.

Keywords

Impact Factor Journal Transparent Manner Academic Misconduct Investigative Effort Reputable Journal 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. 1.
    Smith TL, et al. Design and results of phase I cancer clinical trials: three-year experience at M.D. Anderson Cancer Center. J Clin Oncol. 1996;14(1):287–95.PubMedGoogle Scholar
  2. 2.
    Estey E, et al. Therapeutic response in phase I trials of antineoplastic agents. Cancer Treat Rep. 1986;70(9):1105–15.PubMedGoogle Scholar
  3. 3.
    Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA. 1990;263(10):1385–9.PubMedCrossRefGoogle Scholar
  4. 4.
    Easterbrook PJ, et al. Publication bias in clinical research. Lancet. 1991;337(8746):867–72.PubMedCrossRefGoogle Scholar
  5. 5.
    Dickersin K, et al. Publication bias and clinical trials. Control Clin Trials. 1987;8(4):343–53.PubMedCrossRefGoogle Scholar
  6. 6.
    Callaham ML, et al. Positive-outcome bias and other limitations in the outcome of research abstracts submitted to a scientific meeting. JAMA. 1998;280(3):254–7.PubMedCrossRefGoogle Scholar
  7. 7.
    Krzyzanowska MK, Pintilie M, Tannock IF. Factors associated with failure to publish large randomized trials presented at an oncology meeting. JAMA. 2003;290(4):495–501.PubMedCrossRefGoogle Scholar
  8. 8.
    Dickersin K, Rennie D. Registering clinical trials. JAMA. 2003;290(4):516–23.PubMedCrossRefGoogle Scholar
  9. 9.
    Thornton A, Lee P. Publication bias in meta-analysis: its causes and consequences. J Clin Epidemiol. 2000;53(2):207–16.PubMedCrossRefGoogle Scholar
  10. 10.
    Savitz DA. Failure to publish results of epidemiologic studies is unethical. Epidemiology. 2000;11(3):361–3.PubMedCrossRefGoogle Scholar
  11. 11.
    Clinical Trials.gov. 2011. Available from: http://clinicaltrials.gov/. Cited 3 Oct 2012.
  12. 12.
    Congress t.U.S. Food and Drug Administration Act of 2007. Congress t.U.S., editor 2007.Google Scholar
  13. 13.
    Clinical trial registration: a statement from the International Committee of Medical Journal editors. Available from: http://www.icmje.org/clin_trial.pdf. Cited 3 Oct 2012.
  14. 14.
    Congress t.U.S. Trial and Experimental Studies Transparency Act of 2012. 2012.Google Scholar
  15. 15.
    Drazen JM. Transparency for clinical trials–the TEST Act. N Engl J Med. 2012;367(9):863–4.PubMedCrossRefGoogle Scholar
  16. 16.
    GlaxoSmithKline. Public disclosure of clinical research. 2012. Available from: http://www.gsk.com/policies/GSK-on-disclosure-of-clinical-trial-information.pdf. 3 Oct 2012
  17. 17.
    Merck. Merck guidelines for publication of clinical trials and related works. 2013. Available from: http://www.merck.com/research/discovery-and-development/clinical-development/Merck-Guidelines-for-Publication-of-Clinical-Trials-and-Related-Works.pdf. Accessed 11 October 2013.
  18. 18.
    Davidoff F, et al. Sponsorship, authorship, and accountability. JAMA. 2001;286(10):1232–4.PubMedCrossRefGoogle Scholar
  19. 19.
    I.C.o.M.J., editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Authorship and Contributorship. 2009. Available from: http://www.icmje.org/ethical_1author.html. 3 Oct 2012.
  20. 20.
    Blum JA, et al. Requirements and definitions in conflict of interest policies of medical journals. JAMA. 2009;302(20):2230–4.PubMedCrossRefGoogle Scholar
  21. 21.
    Amdur RJ, Biddle C. Institutional review board approval and publication of human research results. JAMA. 1997;277(11):909–14.PubMedCrossRefGoogle Scholar
  22. 22.
    Ruiz-Canela M, et al. Informed consent and approval by institutional review boards in published reports on clinical trials. N Engl J Med. 1999;340(14):1114–5.PubMedCrossRefGoogle Scholar
  23. 23.
    Schroter S, et al. Reporting ethics committee approval and patient consent by study design in five general medical journals. J Med Ethics. 2006;32(12):718–23.PubMedCrossRefGoogle Scholar
  24. 24.
    N.I.o. Health, editor. NIH policy for data and safety monitoring. 1998. Available from: http://grants.nih.gov/grants/guide/notice-files/not98-084.html. Accessed 11 October 2013.
  25. 25.
    C.f.B.E.a.R. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, editors. Guidance for clinical trial sponsors. Establishment and operation of clinical trial data monitoring. 2006. Available from: http://www.fda.gov/downloads/Regulatoryinformation/Guidances/ucm127073.pdf. Accessed 11 October 2013.
  26. 26.
    Drazen JM, Wood AJ. Don’t mess with the DSMB. N Engl J Med. 2010;363(5):477–8.PubMedCrossRefGoogle Scholar
  27. 27.
    Mathieu S, et al. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA. 2009;302(9):977–84.PubMedCrossRefGoogle Scholar
  28. 28.
    Al-Marzouki S, et al. Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet. Lancet. 2008;372(9634):201.PubMedCrossRefGoogle Scholar
  29. 29.
    Wang R, et al. Statistics in medicine–reporting of subgroup analyses in clinical trials. N Engl J Med. 2007;357(21):2189–94.PubMedCrossRefGoogle Scholar
  30. 30.
    Trials C.S.o.R. CONSORT 2010 checklist of information to include when reporting a randomised trial. 2010. Available from: www.consort-statement.org/index.aspx?o=2965.
  31. 31.
    I.C.o.M.J., editor. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Manuscript Preparation and Submission: Preparing a Manuscript for Submission to a Biomedical Journal. 2009. Available from: http://www.icmje.org/manuscript_1prepare.html. 4 Oct 2012.
  32. 32.
    Devereaux PJ, et al. An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods. J Clin Epidemiol. 2004;57(12):1232–6.PubMedCrossRefGoogle Scholar
  33. 33.
    Pocock SJ, Travison TG, Wruck LM. How to interpret figures in reports of clinical trials. BMJ. 2008;336(7654):1166–9.PubMedCrossRefGoogle Scholar
  34. 34.
    Wainer H. How to display data badly. Am Stat. 1984;38:137–47.Google Scholar
  35. 35.
    Kelleher C, Wagener T. Ten guidelines for effective data visualization in scientific publications. Environ Model Software. 2011;26:822–7.CrossRefGoogle Scholar
  36. 36.
    Freeman JV, Walters S, Campbell MJ. How to display data. How to series. 1st ed. Wiley, John & Sons, Oxford, UK, Incorporated; 2008.Google Scholar
  37. 37.
    Das N, Panjabi M. Plagiarism: why is it such a big issue for medical writers? Perspect Clin Res. 2011;2(2):67–71.PubMedCrossRefGoogle Scholar
  38. 38.
    Hopewell S, et al. Time to publication for results of clinical trials. Cochrane Database Syst Rev. 2007;2:MR000011.PubMedGoogle Scholar
  39. 39.
    Ross JS, et al. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012;344:d7292.PubMedCrossRefGoogle Scholar
  40. 40.
    Hrynaszkiewicz I, et al. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. BMJ. 2010;340:c181.PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag London 2014

Authors and Affiliations

  • Babak J. Orandi
    • 1
  • Julie A. Freischlag
    • 1
  • Mahmoud Malas
    • 2
  1. 1.Department of SurgeryJohns Hopkins HospitalBaltimoreUSA
  2. 2.Department of Vascular and Endovascular SurgeryJohns Hopkins Bayview Medical CenterBaltimoreUSA

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