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Agreements may constrain publication of trial results


 

Preparing drug capsules

for a clinical trial

Photo by Esther Dyson

Publication agreements between industry and academic investigators involved in clinical trials are not often reported in the publications themselves, according to a study published in PLOS Medicine.

In most of the agreements studied, industry had the right to reject or review manuscripts before publication.

Therefore, according to researchers, publication agreements may compromise the scientific evidence base established by randomized clinical trials.

Matthias Briel, MD, of the University Hospital Basel in Switzerland, and his colleagues sought to understand how publication agreements might constrain the publication of trial results.

The researchers examined publication agreements in 647 randomized trial protocols approved from 2000 to 2003 by 6 research ethics committees in Switzerland, Canada, and Germany, as well as the 388 corresponding journal publications.

The team found that 71% 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.

And 74% of the agreements documented in protocols were not mentioned in corresponding journal articles.

The researchers noted that half of the included journal articles were published before 2008, leaving open the possibility that these findings do not reflect current practice.

Nonetheless, the team said the findings suggest that more transparency on publication constraints is warranted.

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