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  11. Agreements Between Industry And Academia On Publication Rights: A Retrospective Study Of Protocols And Publications Of Randomized Clinical Trials.

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

Benjamin Kasenda1, Erik von Elm2, John J You3,4

  • 1Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.

Plos Medicine
|June 29, 2016

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View abstract on PubMed

Summary
This summary is machine-generated.

Publication agreements between industry and academic researchers often restrict publication rights. These agreements are rarely fully disclosed in journal articles, and reported details may conflict with original trial protocols.

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Area of Science:

  • Clinical Trials
  • Publication Ethics

Background:

  • Publication agreements between industry and academic researchers are not well understood.
  • Investigating these agreements in trial protocols and their consistency in publications is crucial.

Purpose of the Study:

  • To examine the existence and nature of publication agreements in industry-sponsored clinical trial protocols.
  • To assess how completely and consistently these agreements are reported in subsequent publications.
  • To determine the frequency of industry employee co-authorship.

Main Methods:

  • Retrospective cohort study of randomized clinical trials (RCTs) with industry involvement.
  • Analysis of archived trial protocols and corresponding journal publications for publication agreement details.
  • Comparison of reported agreements in publications against protocol documentation.

Main Results:

  • 70.5% of RCT protocols mentioned publication agreements, with 86.2% granting industry review or disapproval rights.
  • Only 62.0% of trials with accessible agreements were published.
  • Publication agreements were often unreported (73.5%) or discrepant (26.8%) in journal articles.
  • Industry co-authorship was present in 37.8% of publications suggesting unrestricted publication.

Conclusions:

  • Industry publication agreements commonly constrain academic authors' independence.
  • Journal publications frequently omit or inaccurately report these agreements, potentially misrepresenting publication constraints.
  • Discrepancies between protocols and publications raise concerns about transparency in academic-industry research collaborations.