Rafael Dal-Ré1, Arthur L Caplan. 1. Clinical Research Program, Pasqual Maragall Foundation, Barcelona, Spain, rfdalre@gmail.com.
Abstract
PURPOSE: Outcome reporting bias is a well-known fact in clinical research. It's critical since readers believe that published articles are reliable and accurate. METHODS: The need for investigators to register the trials at the start have made it possible to compare the content of the published article with the registered information. RESULTS: Nearly one-third of clinical trials have changed their primary outcome from the time of registration to publication. CONCLUSIONS: Editors should implement measures aimed at preventing outcome reporting bias. To this end, it is proposed that authors, when submitting a manuscript to a journal, should also submit all trial information they have posted on a registry. Authors should comment on the accuracy and completeness of the information provided in the manuscript with respect to that included on the registry. Peer review should only start after the editorial staff has checked the accuracy of the manuscript content with the trial's registered information. This straightforward, although admittedly somewhat demanding exercise for editorial staff, will help ensure the accuracy of published articles and, hence, reduce outcome reporting bias.
PURPOSE: Outcome reporting bias is a well-known fact in clinical research. It's critical since readers believe that published articles are reliable and accurate. METHODS: The need for investigators to register the trials at the start have made it possible to compare the content of the published article with the registered information. RESULTS: Nearly one-third of clinical trials have changed their primary outcome from the time of registration to publication. CONCLUSIONS: Editors should implement measures aimed at preventing outcome reporting bias. To this end, it is proposed that authors, when submitting a manuscript to a journal, should also submit all trial information they have posted on a registry. Authors should comment on the accuracy and completeness of the information provided in the manuscript with respect to that included on the registry. Peer review should only start after the editorial staff has checked the accuracy of the manuscript content with the trial's registered information. This straightforward, although admittedly somewhat demanding exercise for editorial staff, will help ensure the accuracy of published articles and, hence, reduce outcome reporting bias.
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