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CLINICAL TRIAL REGISTRATION
Any clinical trial for which patient enrollment began on or after November 1, 2006 must be registered. Authors have 6 months from the first patient enrollment to register the trial, but JCO recommends registration prior to enrollment. This registration policy applies to prospective, randomized, controlled trials only.
JCO uses the International Committee of Medical Journal Editors (ICMJE) definition of a clinical trial: "Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. By 'medical intervention' we mean any intervention used to modify a health outcome. This definition includes drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like... a trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration" (see "Clinical trial registration: A statement from the International Committee of Medical Journal Editors." N Engl J Med 351:1250, 2004).
The ICMJE lists the following registeries as fully compliant:
www.actr.org.au
www.clinicaltrials.gov
www.controlled-trials.com
www.umin.ac.jp/ctr/index.htm
www.trialregister.nl
For more information, please see the ICMJE's Obligation to Register Clinical Trials and "Clinical Trials Registration: Will Your Study Be Publishable?" J Clin Oncol, 27:1, 2009.
Upon submission, authors must provide the registration identification number and the URL for the trial's registry.
Authors can post their results in clinical trial registries as part of these requirements without it being considered previously published or overlapping publication.
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