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A Uniform Clinical Trial Registration Policy for Journals of Kidney Diseases, Dialysis and Transplantation Clinical trials provide important information that can profoundly influence the direction of medical research and clinical care. It is crucial that this process is not unduly influenced by selective publication of clinical trial results. Information regarding all clinical trials should therefore be made available to the general public. In common with other nephrology journals, Nephron requires that from 2006 all submitted manuscripts concerning clinical trials must be registered in a public trials registry. The full text of a recent statement published by the editors of Kidney International; The Journal of the American Society of Nephrology; Nephrology, Dialysis, Transplantation; The American Journal of Transplantation; The American Journal of Kidney Diseases, and Transplantation is reproduced below. The policy described in this text has now been formally adopted by Nephron. 'Medical research can be seriously compromised by the selective publication of clinical trial results. Therefore, it is imperative that information regarding clinical trials should be available to the general public. We require, as a condition of consideration for publication, registration in a public trials registry. Trials must register at or before the onset of patient enrolment.' Since 1 April 2006, Nephron no longer accepts manuscripts concerning non-registered trials. 'We define 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. Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g. phase 1 trials) are exempt. We do not advocate any one particular registry, but registration must be with a registry that meets the following minimum criteria: methodology, intervention and comparisons, eligibility criteria, primary and secondary outcomes measured, date of registration, anticipated or actual start date, anticipated or actual date of last follow-up, target number of subjects, status (anticipated, ongoing or closed) and funding source(s). Registries that currently meet these criteria include: |
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Copyright© 2006 S. Karger AG, Basel |
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