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Obligation to Register Clinical Trials

The ICMJE believes that it is important to foster a comprehensive, publicly available database of clinical trials. The ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.

The ICMJE member journals will require, as a condition of consideration for publication in their journals, registration in a public trials registry. The details of this policy are contained in a series of editorials (see Editorials, under Frequently Asked Questions). The ICMJE encourages editors of other biomedical journals to adopt similar policy.

The ICMJE does not advocate one particular registry, but its member journals will require authors to register their trial in a registry that meets several criteria. The registry must be accessible to the public at no charge. It must be open to all prospective registrants and managed by a not-for-profit organization. There must be a mechanism to ensure the validity of the registration data, and the registry should be electronically searchable. Trial registration with missing fields or fields that contain uninformative terminology is inadequate.

It is important to note that the ICMJE requires registration of trial methodology but does not require registration of trial results; it recognizes the potential problems that could arise from the posting of research results that have not been subjected to an independent peer-review process.However, the ICMJE understands that the U.S. Food and Drug Administration Amendments Act of 2007 (FDAAA) does require researchers to register results. The ICMJE will not consider results to be previous publication if they are posted in the same primary clinical trial registry as the initial registration and if the results are posted in the tabular form dictated by the FDAAA. Researchers should be aware that editors of journals that follow the ICMJE recommendations may consider more detailed description of trial results and results published in registries other than the primary registry (in the case of FDAAA, to be prior publication. The ICMJE anticipates that the climate for results registration will change dramatically over coming years and the ICMJE may need to amend these recommendations as additional agencies institute other mandates related to results registration.

The ICMJE recommends that journals publish the trial registration number at the end of the abstract. The ICMJE also recommends that, whenever a registration number is available, authors list this number the first time they use a trial acronym to refer to either the trial they are reporting or to other trials that they mention in the manuscript.