Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors

• Published in: Canadian Medical Association journal (CMAJ) Vol. 172; no. 13; pp. 1700 - 1702
• Main Authors: De Angelis, Catherine D, Drazen, Jeffrey M, Frizelle, Frank A, Haug, Charlotte, Hoey, John, Horton, Richard, Kotzin, Sheldon, Laine, Christine, Marusić, Ana, Overbeke, A John P M, Schroeder, Torben V, Sox, Hal C, Van Der Weyden, Martin B
• Format: Journal Article
• Language: English
• Published: Canada CMA Impact Inc 21.06.2005; CMA Impact, Inc; Canadian Medical Association
• Subjects: Bioethics; Clinical trials; Clinical Trials as Topic - standards; Editorial Policies; Medical research; Medicine, Experimental; Periodicals as Topic; Registries - standards; International Committee of Medical Journal Editors; Biomedical and Behavioral Research
• ISSN: 0820-3946; 1488-2329
• DOI: 10.1503/cmaj.050600

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 enrolment of the first patient. This policy applies to trials that start recruiting on or after July 1, 2005. Because many ongoing trials were not registered at inception, we will consider for publication ongoing trials that are registered before Sept. 13, 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 decide to report and that journal editors decide to publish. Among the trials that meet this definition, which need to be registered? The ICMJE wants to ensure public access to all "clinically directive" trials - trials that test a clinical hypothesis about health outcomes (e.g., "Is drug X as effective as drug Y in treating heart failure?"). We have excluded trials from our registration requirement if their primary goal is to assess major unknown toxicity or to determine pharmacokinetics (phase 1 trials). In contrast, we think the public deserves to know about trials that could shape the body of evidence about clinical effectiveness or adverse effects. Therefore, we require registration of all trials whose primary purpose is to affect clinical practice (phase 3 trials). Between these 2 extremes are some clinical trials whose prespecified goal is to investigate the biology of disease or to provide preliminary data that may lead to larger, clinically directive trials.