Publication agreements constraining academic investigators' independence are common, and incompletely reported in publications, according to a study published in this week's PLOS Medicine. The study, conducted by Matthias Briel, University Hospital Basel, Switzerland, and colleagues, suggests that publication agreements may compromise the scientific evidence base established by randomized clinical trials.
Many randomized trials are designed and sponsored by for-profit companies that contract academic investigators to recruit and manage patients. Briel and colleagues sought to understand how these agreements might constrain publication of trial results. The researchers investigated publication agreements in 647 randomized trial protocols approved in 2000-2003 by six research ethics committees in Switzerland, Canada, and Germany, and the 388 corresponding journal publications. They found that 70% of protocols mentioned an agreement on publication rights between industry and academic investigators; in 86% of those agreements, industry retained the right to disapprove or at least review manuscripts before publication. 74% of agreements documented in protocols were not mentioned in corresponding journal articles.
Half of the included journal articles were published before 2008, leaving open the possibility that these findings do not reflect current practice. Nonetheless, the findings suggest that more transparency on publication constraints is warranted. The authors state, "[c]linical research under these circumstances is a business transaction that bears the potential for conflicts of interest, including those regarding the publication of trial results."
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