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Top medical journals to demand public registration of clinical trials
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Eleven prominent medical journals announced this week that they no longer will publish the results of any clinical trial that is not registered in a public trials registry from its outset.
The new policy, which will take effect after deadlines next year, was announced in an editorial simultaneously published in all the journals. The editorial was written by the members of the International Committee of Medical Journal Editors (ICMJE), a group of general medical journal editors who meet annually to develop rules for manuscript submission. The ICMJE includes the editors of prestigious peer-reviewed publications such as the Journal of the American Medical Association, New England Journal of Medicine and The Lancet.
As a condition of publication, the 11 journals will require all trials to be registered in a public trials registry that meets specific criteria, including free public access and management by a nonprofit organization. An acceptable registry must include a unique identification number, a statement of the intervention being evaluated, primary and secondary outcomes measures, patient eligibility, and the source of trial funding, among other criteria, according to the editorial.
The ICMJE editorial defined a clinical trial as “any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.” Other studies, such as toxicity studies, would be exempt from the registration rules, the editorial said.
At present, only www.ClinicalTrials.gov, a Web site sponsored by the National Library of Medicine, meets these requirements, according to the authors. Other registries that meet their criteria would also be acceptable, the authors said.
The initiative is intended to counter selective reporting of clinical trials by drug manufacturers and researchers, the authors said.
“The case against selective reporting is particularly compelling for research that tests interventions that could enter mainstream clinical practice,” the editorial said in part. “When research sponsors or investigators conceal the presence of selected trials, these studies cannot influence the thinking of patients, clinicians, other researchers and experts who write practice guidelines or decide on insurance-coverage policy.”
“Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials,” they said.
The policy will apply to any trial that begins patient enrollment after July 1, 2005, according to the editorial. Trials that began enrollment prior to that date will be required to register by Sept. 13, 2005, to be considered for publication, the authors said.
The guidelines at present only apply to journals who are members of the ICMJE, “but we encourage editors of other biomedical journals to adopt similar policies,” the authors said.
The full editorial can be read at the ICMJE Web site: www.icmje.org.