In a joint editorial, the members of the International Committee of Medical Journal Editors (ICMJE), said they will consider publishing results of clinical trials that begin enrollment on or after July 1, 2005, only if the trial has been entered in a registry that is electronically searchable and publicly accessible at no charge before the first patient is enrolled.
The journals will accept retrospective registration of trials that began enrollment before July 2005 as long as registration is complete by Sept. 13, 2005.
The editorial, "Is This Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors," will be released on www.ICMJE.org and on individual journal Web sites on May 23 at 5 p.m. EDT.
Harold Sox, MD, editor of Annals of Internal Medicine, said that the editorial amplifies the drug trial registry concept that ICMJE first put forth in a joint editorial in September 2004.
"Our first editorial was a wake-up call for researchers, trial authors and sponsors. This editorial reaffirms our intent and tells researchers what they must do to meet our requirements for editorial review and subsequent publication," Sox said.
The ICMJE editorial tells researchers that they must not leave out key information when they register a trial. Specifically, ICJME says that researchers must name the treatment in a meaningful way so that patients and others know what intervention is under study.
The editorial also advises authors not to "use meaningless phrases to describe key information."
Christine Laine, MD, senior deputy editor of Annals of Internal Medicine, said that the ICMJE has adopted the World Health Organization's minimal data set, or list of required items that each trial must include.
"WHO, which has also been working on trials registration, came up with a set of 20 required data elements remarkably like ours," said Laine. "We hope that by harmonizing WHO and ICMJE policies, we can move toward a meaningful registration process that is truly global."
Notes to Editor:
Journals participating in and publishing the ICMJE editorial are Annals of Internal Medicine, JAMA, The New England Journal of Medicine, The New Zealand Medical Journal, Norwegian Medical Journal, CMAJ (Canadian Medical Association Journal), The Lancet, MEDLINE/National Library of Medicine, Croatian Medical Journal, Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine), Journal of the Danish Medical Association, and The Medical Journal of Australia.
Annals of Internal Medicine, the world's most widely cited peer-reviewed specialty journal, is published twice monthly by the American College of Physicians (ACP) in Philadelphia. With more than 116,000 members, ACP is the second-largest medical association in the United States. ACP members are internists: specialists in the prevention, detection, and treatment of illnesses that primarily affect adults.
Journal
Annals of Internal Medicine