Can Clinical Trial Results Databases and Manuscripts Coexist?

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 publishing traditional manuscripts) play important roles in the dissemination of clinical trial results, but current requirements now test the medical journals' policies, which effectively reserve the right of the journal to be the primary source for clinical trial data. As sponsors struggle to meet the legal clinical trial disclosure requirements while attempting to get manuscripts published, it is not clear at this time what the final impact will be on sponsors, journals, investigators, health care providers, the media, and the ultimate customer, the patient.