Important note: Information in this article was accurate in October 2004. The state of the art may have changed since the publication date.
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HIV Treatment Bulletin - Vol. 5, No. 9/10, October/November 2004
A statement form the International Committee of Medical Journal Editors, whose members include The Lancet, New England Journal of Medicine, JAMA and Medline (US National Library of Medicine) committed these and other member publications to new criteria for any study reports submitted for publication.
The move is an attempt to maintain a record of trials that find either negative or inconclusive results and which are less likely to be submitted for publication.
All studies need to be registered at or before patient enrollment on a ‘free-to-view’ accessible electronically searchable database that is managed by a not-for-profit organisation.
An acceptable registry must include at minimum the following information: a unique identifying number, a statement of the intervention (or interventions) and comparison (or comparisons) studied, a statement of the study hypothesis, definitions of the primary and secondary outcome measures, eligibility 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 considered complete), target number of subjects, funding source, and contact information for the principal investigator.
The statement only mentions one currently available database that meets these criteria:
Source: Editorial, NEJM, September 2004
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