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July 4, 2007

Clinical Trial Registration: Looking Back and Moving Ahead

Author Affiliations

Author Affiliations: Dr Laine is senior deputy editor, Annals of Internal Medicine; Dr Horton is editor, The Lancet; Dr DeAngelis is editor-in-chief, JAMA; Dr Drazen is editor-in-chief, New England Journal of Medicine; Dr Frizelle is editor-in-chief, The New Zealand Medical Journal; Dr Godlee is editor-in-chief, BMJ; Dr Haug is editor-in-chief, Norwegian Medical Journal; Dr Hébert is editor-in-chief, CMAJ; Mr Kotzin is executive editor, MEDLINE, National Library of Medicine; Dr Marusic is editor, Croatian Medical Journal; Dr Sahni is representative and past president, World Association of Medical Editors; Dr Schroeder is editor, Journal of the Danish Medical Association; Dr Sox is editor, Annals of Internal Medicine; Dr Van Der Weyden is editor, The Medical Journal of Australia; and Dr Verheugt is executive editor, Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine).


Published online June 4, 2007 (doi:10.1001/jama.298.1.jed70037).

JAMA. 2007;298(1):93-94. doi:10.1001/jama.298.1.jed70037

In 2005, the International Committee of Medical Journal Editors (ICMJE) initiated a policy requiring investigators to deposit information about trial design into an accepted clinical trials registry before the onset of patient enrollment.1 This policy aimed to ensure that information about the existence and design of clinically directive trials was publicly available, an ideal that leaders in evidence-based medicine have advocated for decades.2 The policy precipitated much angst among research investigators and sponsors, who feared that registration would be burdensome and would stifle competition. Yet, the response to this policy has been overwhelming. The ICMJE promised to reevaluate the policy in 2 years after implementation. Here, we summarize that reevaluation, specifically commenting on registries that meet the policy requirements, the types of studies that require registration, and the registration of trial results. As is always the case, the ICMJE establishes policy only for the 12 member journals (a detailed description of the ICMJE and its purpose is available at www.icmje.org), but many other journals have adopted our initial trial registration recommendations, and we hope that they will also adopt the modifications discussed in this update.