Registration of Clinical Trials
Authors: Alain Braillon, Gérard Dubois, Michel Slama
Journal: Annals of Internal Medicine (2005)

Letters1 February 2005Registration of Clinical TrialsAlain Braillon, MD, Gérard Dubois, MD, and Michel Slama, MDAlain Braillon, MDFrom Délégation Régionale à la Recherche Clinique, Centre Hospitalier Universitaire, 80000 Amiens, France.Search for more papers by this author, Gérard Dubois, MDFrom Délégation Régionale à la Recherche Clinique, Centre Hospitalier Universitaire, 80000 Amiens, France.Search for more papers by this author, and Michel Slama, MDFrom Délégation Régionale à la Recherche Clinique, Centre Hospitalier Universitaire, 80000 Amiens, France.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-142-3-200502010-00026 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:As a condition of consideration for publication, the International Committee of Medical Journal Editors (ICMJE) will soon require authors to register clinical trials in a public trials registry (1). The intent is to improve reliability and quality of clinical research. But why has the ICMJE created a new definition of clinical trial that differs greatly from the one established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use? The ICMJE also sets conditions that make www.clinicaltrials.gov the only registry that meets its criteria, ignoring the fact that since May 2004, ...References1. 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]. Ann Intern Med. 2004;141:477-8. [PMID: 15355883] LinkGoogle Scholar2. Article 11. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities. 1 May 2001. Available at europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf. Google Scholar Author, Article, and Disclosure InformationAffiliations: From Délégation Régionale à la Recherche Clinique, Centre Hospitalier Universitaire, 80000 Amiens, France. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoClinical Trial Registration: A Statement from the International Committee of Medical Journal Editors Catherine De Angelis , Jeffrey M. Drazen , 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 Registration of Clinical Trials Christine Laine and Harold C. Sox Metrics Cited byA review of international clinical trial registration 1 February 2005Volume 142, Issue 3Page: 228KeywordsClinical trialsDatabasesResearch quality assessment ePublished: 1 February 2005 Issue Published: 1 February 2005 Copyright & PermissionsCopyright © 2005 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...