Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors

Abstract

In September, 2004, the members of the International Committee of Medical Journal Editors (ICMJE) published a joint editorial aimed at promoting registration of all clinical trials. 1 De Angelis C Drazen JM Frizelle FA for the International Committee of Medical Journal EditorsClinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet. 2004; 364: 911-12 Summary Full Text Full Text PDF PubMed Scopus (249) Google Scholar We stated that we will consider a trial for publication only if it has been registered before the enrolment of the first patient. This policy applies to trials that start recruiting on or after July 1, 2005. Because many ongoing trials were not registered at inception, we will consider for publication ongoing trials that are registered before Sept 13, 2005. Our goal then and now is to foster a comprehensive, publicly available database of clinical trials. A complete registry of trials would be a fitting way to thank the thousands of participants who have placed themselves at risk by volunteering for clinical trials. They deserve to know that the information that accrues from their altruism is part of the public record, where it is available to guide decisions about patient care. They deserve to know that decisions about their care rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish. WHO facilitates international collaboration in setting standards for clinical trial registrationClinical trial registration has been a popular topic in the past 12 months. WHO,1 the pharmaceutical industry,2 several national research institutions,3 and independent groups4 have published statements in favour of trial registration and disclosure of the results. Perhaps the most influential statement came from the International Committee of Medical Journal Editors (ICMJE) who stated that after July 1, 2005, trials that are not registered will not be considered for publication.5 Full-Text PDF