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Reporting of Negative Randomized Trials in Three Major Medical Journals

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Author(s): Gabriel A. Brooks | Daniel W. Bowles | Daniel B. Jamieson | Janice V. Huang | Alexandra Smart | Kathleen A. Heist | Traci E. Yamashita | Allan V. Prochazka | Ravi K. Gopal

Journal: International Journal of Clinical Medicine
ISSN 2158-284X

Volume: 04;
Issue: 02;
Start page: 108;
Date: 2013;
Original page

Keywords: Clinical Trial Registration | Publication Bias | Randomized Trials | Clinical Trials | Non-Inferiority Trials

ABSTRACT
Context: In recent years there has been increasing interest on publication bias and on initiatives to decrease bias, in- cluding trial registration. Objective: To test whether there has been an increase in reports of randomized control trials (RCT’s) with negative outcomes in major journals and to identify factors associated with these reports. Design: Retrospective review of reports of RCT’s published in the Journal of the American Medical Association, The Lancet and the New England Journal of Medicine before (2002-’03, pre-registration era) and after (2007-’08, registration era) the institution of mandatory trial registration. Main Outcome Measure: The primary outcome was the proportion of RCT reports with negative outcomes compared across the two eras. Secondary outcome includes other factors affecting pub-lication. Results: We identified 917 reports of RCT’s published in the two study eras. No publications in the pre-registration era reported trial registration compared with 94.4% in the registration era (p
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