January 2005

Clinical Trial RegistrationA Step Forward in Providing Transparency for the Positive and Negative Results of Clinical Trials

Author Affiliations

Copyright 2005 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2005

Arch Dermatol. 2005;141(1):75. doi:10.1001/archderm.141.1.75

The editors and editorial board of the Archives of Dermatology adopted the plan articulated by JAMA Editor Catherine DeAngelis, MD, and colleagues from the International Committee of Medical Journal Editors (ICMJE) regarding clinical trial registration. The ICMJE recognizes the need for pharmaceutical and device manufacturers to register all clinical trials involving human subjects before recruiting participants.1 Herein we reprint the ICMJE statement, published in all member journals, explaining the need for requiring trial registration in a public trials registry as a condition for consideration for publication. Therefore, beginning with clinical trials initiated after July 1, 2005, the ICMJE will require a statement from the principal author that the study discussed in a submitted manuscript is registered in a public trials registry and that a link to a publicly accessible Web site supplying all relevant information about the registered trial, such as www.clinicaltrials.gov,2 is provided in the article. In addition, for trials that began enrollment prior to this date, registration by September 13, 2005, will be required. Thus, as they assess one study, interested parties, including reviewers and editorial staff, will be able to access related studies and request results of these studies. We believe that this process will provide the fair balance that our readers need as they access the information published in the ARCHIVES.

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