Publishing a Clinical Trial
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.
KeywordsImpact Factor Journal Transparent Manner Academic Misconduct Investigative Effort Reputable Journal
- 11.Clinical Trials.gov. 2011. Available from: http://clinicaltrials.gov/. Cited 3 Oct 2012.
- 12.Congress t.U.S. Food and Drug Administration Act of 2007. Congress t.U.S., editor 2007.Google Scholar
- 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.Congress t.U.S. Trial and Experimental Studies Transparency Act of 2012. 2012.Google Scholar
- 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.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.
- 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.
- 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.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.
- 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.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.
- 34.Wainer H. How to display data badly. Am Stat. 1984;38:137–47.Google Scholar
- 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