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Clinical Trial Registration
A Step Forward in Providing Transparency for the Positive and Negative Results of Clinical Trials
Arch Dermatol. 2005;141:75.
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.
In addition to the benefits to our reviewers and readers and, beyond them, the public, we believe that registration is also of potential benefit to investigators as they recruit trial subjects. An unintended benefit of the registration of a clinical trial is that as people "surf" the Web, they will be able to identify research studies in which they might wish to participate.
During our October 2004 editorial board meeting, we discussed what types of studies this policy might affect and how it might be administered. This policy will affect all phase II, III, and IV studies of drugs and devices, whether they are initiated by an investigator or by a company. It is neither time consuming nor costly, as trial registration on a Web site would be free and take only minutes to complete. Is this regulation needed? We believe that the answer is overwhelmingly yes, as we have witnessed the spin of positive results and the dearth of adverse events published. We can all remember, somewhat glibly, the old adage, "Use this new therapy now, before it is proven not to work!" This program of trial registration ought to allow us to know whether a studied treatment has received negative reports in addition to the positive one that is being submitted for publication.
Another question debated at our board meeting was the sort of studies that would be exempt from this requirement. Retrospective analyses of data obtained during the routine practice of medicine or an off-label use of a drug or device in an individual patient or a small set of patients do not need to be registered to be discussed in a published article. However, we reached the opinion that prospective trials that have enough power to be statistically relevant should be registered even if they are not supported by a pharmaceutical company or a device manufacturer. If you have specific questions about this policy as you initiate investigative studies, please feel free to contact us at our offices or via e-mail at archdematol{at}jama-archives.org.
AUTHOR INFORMATION
Correspondence: Dr Robinson, Archives of Dermatology, Section of Dermatology, Level 2, Bldg 11, Room 503, Dartmouth-Hitchcock Medical Center Drive, One Medical Center Drive, Lebanon, NH 03756 (archdermatol{at}jama-archives.org).
Financial Disclosure: None.
Jeffrey P. Callen, MD, Associate Editor;
June Robinson, 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. ClinicalTrials.gov. Available at http://www.clinicaltrials.gov. Accessed August 8, 2004.
RELATED ARTICLE
Clinical Trial Registration: A Statement From the International Committee of Medical Journal Editors
Catherine D. DeAngelis, 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, Hal C. Sox, and Martin B. Van Der Weyden
Arch Dermatol. 2005;141(1):76-77.
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