Abstract

Recent changes in US legal obligations to disclose clinical trial results have created confounding challenges for sponsors of clinical trials and for editors of medical and scientific journals with policies prohibiting prepublication of clinical trial data. For nearly two centuries, peer-reviewed manuscripts have served as the primary means of scientific communication. In recent years, however, criticisms of the delay in publishing clinical trial data and publication bias have increased. Prominent journal editors have strongly suggested that online clinical trial registration prior to study conduct would mitigate these concerns. With the recent addition of legally mandated clinical trial results disclosure within specified time limits on ClinicalTrials.gov, the very registries and results databases once used in part to address publication bias may now actually jeopardize the ability to publish the results in peer-reviewed medical journals. Both types of disclosure (ie, posting in results databases and pub...

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