PLoS Medicine (Jun 2016)

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

  • Benjamin Kasenda,
  • Erik von Elm,
  • John J You,
  • Anette Blümle,
  • Yuki Tomonaga,
  • Ramon Saccilotto,
  • Alain Amstutz,
  • Theresa Bengough,
  • Joerg J Meerpohl,
  • Mihaela Stegert,
  • Kelechi K Olu,
  • Kari A O Tikkinen,
  • Ignacio Neumann,
  • Alonso Carrasco-Labra,
  • Markus Faulhaber,
  • Sohail M Mulla,
  • Dominik Mertz,
  • Elie A Akl,
  • Dirk Bassler,
  • Jason W Busse,
  • Ignacio Ferreira-González,
  • Francois Lamontagne,
  • Alain Nordmann,
  • Viktoria Gloy,
  • Heike Raatz,
  • Lorenzo Moja,
  • Shanil Ebrahim,
  • Stefan Schandelmaier,
  • Xin Sun,
  • Per O Vandvik,
  • Bradley C Johnston,
  • Martin A Walter,
  • Bernard Burnand,
  • Matthias Schwenkglenks,
  • Lars G Hemkens,
  • Heiner C Bucher,
  • Gordon H Guyatt,
  • Matthias Briel

DOI
https://doi.org/10.1371/journal.pmed.1002046
Journal volume & issue
Vol. 13, no. 6
p. e1002046

Abstract

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BackgroundLittle is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees.Methods and findingsWe used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.ConclusionsPublication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.