International Committee of Medical Journal Editors' Definition of a Clinical Trial
Authors: Carlos Campillo-Artero
Journal: Annals of Internal Medicine (2005)

Letters6 December 2005International Committee of Medical Journal Editors' Definition of a Clinical TrialCarlos Campillo-Artero, MDCarlos Campillo-Artero, MDFrom Instituto Balear de la Salud, Palma de Mallorca 07003, Spain.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-143-11-200512060-00023 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Although I fully support the statements included in the editorial recently published in the New England Journal of Medicine about the registration of all clinical trials (1), I would like to pinpoint an important nuance concerning the stated definition of a trial: “Any research project that assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.” Neither this definition nor the International Committee of Medical Journal Editors' (ICMJE) 2004 editorial (2) include any mention of the type of assignment of human participants to the intervention and ...References1. 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 [Editorial]. N Engl J Med. 2005;352:2436-8. [PMID: 15911780] CrossrefMedlineGoogle Scholar2. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [Editorial]. N Engl J Med. 2004;351:1250-1. [PMID: 15356289] CrossrefMedlineGoogle Scholar3. Meinert CL. Clinical Trials: Design, Conduct, and Analysis. New York: Oxford Univ Pr; 1986. Google Scholar4. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134:663-94. [PMID: 11304107] LinkGoogle Scholar Author, Article, and Disclosure InformationAuthors: Carlos Campillo-Artero, MDAffiliations: From Instituto Balear de la Salud, Palma de Mallorca 07003, Spain.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoThe Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration Douglas G. Altman , Kenneth F. Schulz , David Moher , Matthias Egger , Frank Davidoff , Diana Elbourne , Peter C. Gøtzsche , and Thomas Lang , for the CONSORT GroupIs This Clinical Trial Fully Registered? Catherine D. De Angelis , Jeffrey M. Drazen , Prof Frank A. Frizelle , Charlotte Haug , John Hoey , Richard Horton , Sheldon Kotzin , Christine Laine , Ana Marusic , A. John P.M. Overbeke , Torben V. Schroeder , Harold C. Sox , and Martin B. Van Der Weyden International Committee of Medical Journal Editors' Definition of a Clinical Trial Christine Laine Metrics 6 December 2005Volume 143, Issue 11Page: 846-847KeywordsClinical trial reportingClinical trialsConflicts of interestIntent to treat analysisResearch design ePublished: 6 December 2005 Issue Published: 6 December 2005 Copyright & PermissionsCopyright © 2005 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...