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Clinical Trial Registration
Arch Neurol. 2005;62:1042.
The editors and editorial board of the Archives of Neurology are implementing the requirement that all clinical trials be registered in a public trials registry as a condition for consideration for publication. This implementation is in support of the plan published by JAMA editor Catherine D. DeAngelis, MD, and editors from the International Committee of Medical Journal Editors (ICMJE) regarding clinical trial registration.1 The ICMJE has recognized the need for device manufacturers and pharmaceutical corporations to register all clinical trials involving human subjects before recruiting participants.
We are in agreement with this policy as clinical trial registration will provide the public in general and our readers with the full range of clinical evidence on the reported clinical trial. Clinical trial registration will enhance the availability of not only the truth, but the whole truth. Selective reporting of only the positive outcomes of a new drug or device will be balanced by the reporting of all facts on the subject—positive, negative, and neutral.
Our policy will be in accord with that of the ICMJE in that all trials must be registered at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began starting enrollment prior to this date, registration will be required by September 13, 2005, before considering the trial for publication.
Registration in a registry must meet specific criteria. There must be a means to validate registration data, the registry must be searchable by electronic programs, a unique identification number, a statement of the intervention(s) and comparison(s) studied, the study hypothesis statement, a statement of the primary and secondary outcomes measures, eligibility and exclusionary criteria, key trial dates (registration date, anticipated or actual start date, anticipated or actual date of last follow-up, planned or actual date of closure to data entry, and date trial data are considered complete), target number of subjects, funding source, and contact information for the primary investigator. These criteria are in accord with the published policies of the ICMJE.1 The Clinical Trials Registry of the US National Library of Medicine meets these requirements and can be accessed at www.clinicaltrials.gov.2
Our clinical trials registration policy will include all phase 2 and 3 studies of drugs and devices. We believe it will enhance the publication of only well-designed studies that reach conclusions on the basis of design that have enough power to be statistically significant and conclusive. The clinical trial registration information will provide the investigator and reader with all the relevant background information to put the reported clinical trial into the proper perspective. If you have any questions or need additional information, please feel free to contact our editorial office either by telephone at (214) 648-9383, or by e-mail at archneurol{at}jama-archives.org.
AUTHOR INFORMATION
Correspondence: Dr Rosenberg, Archives of Neurology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-9108 (Roger.Rosenberg{at}UTSouthwestern.edu).
Roger N. Rosenberg, MD, Editor
REFERENCES
1. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363-1364.
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2. National Institutes of Health, National Library of Medicine. ClinicalTrials. Available at: http://www.clinicaltrials.gov. Accessed August 18, 2004.
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