190
Views
19
CrossRef citations to date
0
Altmetric
Randomized controlled trial

Comparison of registered and published primary outcomes in randomized controlled trials of gastroenterology and hepatology

, MD, , MM, , MD, , MD, , MD & , MD
Pages 1474-1483 | Received 27 Aug 2013, Accepted 09 Sep 2013, Published online: 16 Oct 2013

References

  • Tonks A. Registering clinical trials. BMJ 1999;319:1565–8.
  • Dickersin K, Rennie D. Registering clinical trials. JAMA 2003;290:516–23.
  • Sim I, Chan AW, Gülmezoglu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet 2006;367:1631–3.
  • Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA 2007;297:2112–20.
  • Yu H, Liu JP. A review of international clinical trial registration. J Chin Integr Med 2007;5:234–42.
  • De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Is this clinical trial fully registered? — A statement from the International Committee of Medical Journal Editors. N Engl J Med 2005;352:2436–8.
  • Zarin DA, Tse T, Ide NC. Trial Registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 2005;353:2779–87.
  • Faure H, Hrynaszkiewicz I. The ISRCTN register: achievements and challenges 8 years on. J Evid Based Med 2011;4:188–92.
  • Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007–2010. JAMA 2012;307:1838–47.
  • van de Wetering FT, Scholten RJ, Haring T, Clarke M, Hooft L. Trial registration numbers are underreported in biomedical publications. PLoS One 2012;7:e49599.
  • Food and Drug Administration Amendments Act of 2007. Available at http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM123579.pdf. Accessed April 30, 2013.
  • Laine C, Horton R, De Angelis C, Drazen JM, Frizelle FA, Godlee F, et al. Clinical trial registration. looking back and moving ahead. BMJ 2007;334:1177–8.
  • Hirsch L. Trial registration and results disclosure: impact of US legislation on sponsors, investigators, and medical journal editors. Curr Med Res Opin 2008;24:1683–9.
  • Krleza-Jerić K, Lemmens T. 7th revision of the. Declaration of Helsinki: good news for the transparency of clinical trials. Croat Med J 2009;50:105–10.
  • Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009;302:977–84.
  • Kunath F, Grobe HR, Keck B, Rücker G, Wullich B, Antes G, et al. Do urology journals enforce trial registration? A cross-sectional study of published trials. BMJ Open 2011;1:e000430.
  • You B, Gan HK, Pond G, Chen EX. Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review. J Clin Oncol 2012;30:210–16.
  • Jones CW, Platts-Mills TF. Quality of registration for clinical trials published in emergency medicine journals. Ann Emerg Med 2012;60:458–64.
  • Hannink G, Gooszen HG, Rovers MM. Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions. Ann Surg 2013;257:818–23.
  • Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 2010;153:158–66.
  • Rasmussen N, Lee K, Bero L. Association of trial registration with the results and conclusions of published trials of new oncology drugs. Trials 2009;10:116.
  • Stanley K. Design of randomized controlled trials. Circulation 2007;115:1164–9.
  • Wyler von Ballmoos M, Oliveira C. The ClinicalTrials.gov results database — Update and key issues. N Engl J Med 2011;364:2169.
  • Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med 2005;2:e138.
  • Chan AW, 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;291:2457–65.
  • Dickersin K, Min YI. NIH clinical trials and publication bias. Online J Curr Clin Trials 1993; Doc No 50.
  • Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326:1167–70.
  • Bero L, Oostvogel F, Bacchetti P, Lee K. Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others. PLoS Med 2007;4:e184.
  • Olson CM, Rennie D, Cook D, Dickersin K, Flanagin A, Hogan JW, et al. Publication bias in editorial decision making. JAMA 2002;287:2825–8.
  • Chan AW. Bias, spin, and misreporting: time for full access to trial protocols and results. PLoS Med 2008;5:e230.
  • Groves T. Mandatory disclosure of trial results for drugs and devices. BMJ 2008;336:170.
  • Ridker PM, Torres J. Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000–2005. JAMA 2006;295:2270–4.
  • Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA 2003;290:921–8.
  • Sismondo S. How pharmaceutical industry funding affects trial outcomes: causal structures and responses. Soc Sci Med 2008;66:1909–14.
  • Roseman M, Milette K, Bero LA, Coyne JC, Lexchin J, Turner EH, et al. Reporting of conflicts of interest in meta-analyses of trials of pharmacological treatments. JAMA 2011;305:1008–17.
  • Golder S, Loke YK. Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies? Br J Clin Pharmacol 2008;66:767–73.
  • Steinbrook R. Registration of clinical trials–voluntary or mandatory? N Engl J Med 2004;351:1820–2.
  • Krleza-Jerić K. Clinical trial registration: the differing views of industry, the WHO, and the Ottawa Group. PLoS Med 2005;2:e378.
  • Wu TX, Li YP, Liu GJ, Li J. Clinical trial registration system and evidence-based medicine. J Chin Integr Med 2007;5:229–33.
  • Cheng CW, Fu SF, Zhou QH, Wu TX, Shang HC, Tang XD, et al. Extending the CONSORT Statement to moxibustion. J Integr Med 2013;11:54–63.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.