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Is This Clinical Trial Fully Registered?
A Statement from the International Committee of Medical Journal Editors*
- Catherine D. De Angelis, MD, MPH;
- Jeffrey M. Drazen, MD;
- Prof Frank A. Frizelle, MB, ChB, MMedSc, FRACS;
- Charlotte Haug, MD, PhD, MSc;
- John Hoey, MD;
- Richard Horton, FRCP;
- Sheldon Kotzin, MLS;
- Christine Laine, MD, MPH;
- Ana Marusic, MD, PhD;
- A. John P.M. Overbeke, MD, PhD;
- Torben V. Schroeder, MD, DMSc;
- Harold C. Sox, MD; and
- Martin B. Van Der Weyden, MD
In September 2004, the members of the International Committee of Medical Journal Editors (ICMJE) published a joint editorial aimed at promoting registration of all clinical trials (1). We stated that we will consider a trial for publication only if it has been registered before the enrollment of the first patient. This policy applies to trials that start recruiting on or after 1 July 2005. Because many ongoing trials were not registered at inception, we will consider for publication ongoing trials that are registered before 13 September 2005. Our goal then and now is to foster a comprehensive, publicly available database of clinical trials. A complete registry of trials would be a fitting way to thank the thousands of participants who have placed themselves at risk by volunteering for clinical trials. They deserve to know that the information that accrues from their altruism is part of the public record, where it is available to guide decisions about patient care, and deserve to know that decisions about their care rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish.
We are not alone in pursuing this goal. The World Health Organization (WHO), through meetings in New York, Mexico City, and Geneva, has brought us close to the goal of a single worldwide standard for the information that trial authors must disclose. Around the world, governments are beginning to legislate mandatory disclosure of all trials. For example, among the bodies considering new legislation is the U.S. Congress, where the proposed Fair Access to Clinical Trials (FACT) Act would expand the current mandate for registration of clinical trials. …
This 100-word excerpt has been provided in the absence of an abstract.
