Cited by 33Pharmaceutical industry and healthcareAcademic integrity and plagiarismAcademic Publishing and Open Access

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

Open access
Kasenda, Benjamin, von Elm, Erik, You, John J., Blümle, Anette, Tomonaga, Yuki, Saccilotto, Ramon, Amstutz, Alain, Bengough, Theresa +30 more·2016·PLOS Medicine

Abstract

BACKGROUND: Little 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 FINDINGS: We 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. CONCLUSIONS: Publication 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.

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  • Trial protocols vary in their completeness and often do not adequately describe important elements including primary outcomes, treatment allocation methods, blinding, adverse event measurement, sample size calculations, data analysis methods, dissemination policies, and roles of sponsors and investigators.

    “However, trial protocols vary in their completeness and often do not address key elements of design and conduct.”
  • These restrictions are sometimes not fully described in the protocol but rather in separate publication agreements.

    “These restrictions are sometimes not fully described in the protocol but rather in separate publication agreements.38 51”

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Research works printed but not linked: 3

  1. [14]The Lancet. Statements, permissions, and signatures. 2016 [cited 13 Feb 2016]. Available: http://www.thelancet.com/lancet/information-for-authors/statements-permissions-signatures.
  2. [15]The New England Journal of Medicine. About NEJM—editorial policies. 2016 [cited 13 Feb 2016]. Available: http://www.nejm.org/page/about-nejm/editorial-policies.
  3. [16]PLoS Medicine. Submission guidelines. 2016 [cited 13 Feb 2016]. Available: http://journals.plos.org/plosmedicine/s/submission-guidelines.

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Authors
Kasenda, B., von Elm, E., You, J. J., Blümle, A., Tomonaga, Y., Saccilotto, R., Amstutz, A., Bengough, T., Meerpohl, J. J., Stegert, M., Olu, K. K., Tikkinen, K. A. O., Neumann, I., Carrasco-Labra, A., Faulhaber, M., Mulla, S. M., Mertz, D., Akl, E. A., Bassler, D., Busse, J. W., Ferreira-González, I., Lamontagne, F., Nordmann, A., Gloy, V., Raatz, H., Moja, L., Ebrahim, S., Schandelmaier, S., Sun, X., Vandvik, P. O., Johnston, B. C., Walter, M. A., Burnand, B., Schwenkglenks, M., Hemkens, L. G., Bucher, H. C., Guyatt, G. H., & Briel, M.
Affiliations
  • University of Basel (CH)
  • McMaster University (CA)
  • University of Freiburg (DE)
  • University of Zurich (CH)
  • Centre Hospitalier Universitaire Vaudois (CH)
  • University of Helsinki (FI)
  • Pontificia Universidad Católica de Chile (CL)
  • Michael G. DeGroote Institute for Infectious Disease Research (CA)
  • University at Buffalo, State University of New York (US)
  • University Hospital Zurich (CH)
  • IRCCS Ospedale Galeazzi - Sant'Ambrogio (IT)
  • Stanford University (US)
  • Sichuan University (CN)
  • Innlandet Hospital Trust (NO)
  • University of Toronto (CA)
  • University Hospital of Bern (CH)
Corresponding author
  • Kasenda, Benjamin
  • You, John J.
  • Blümle, Anette
  • Tomonaga, Yuki
  • Saccilotto, Ramon
  • Amstutz, Alain
  • Bengough, Theresa
  • Meerpohl, Joerg J.
  • Stegert, Mihaela
  • Olu, Kelechi K.
  • Tikkinen, Kari A. O.
  • Neumann, Ignacio
  • Faulhaber, Markus
  • Mulla, Sohail M.
  • Mertz, Dominik
  • Akl, Elie A.
  • Bassler, Dirk
  • Busse, Jason W.
  • Nordmann, Alain
  • Gloy, Viktoria
  • Raatz, Heike
  • Moja, Lorenzo
  • Ebrahim, Shanil
  • Schandelmaier, Stefan
  • Sun, Xin
  • Vandvik, Per O.
  • Johnston, Bradley C.
  • Walter, Martin A.
  • Burnand, Bernard
  • Schwenkglenks, Matthias
  • Hemkens, Lars G.
  • Bucher, Heiner C.
  • Guyatt, Gordon H.
  • Briel, Matthias
Venue
PLOS Medicine
Published
2016-06-28
Volume
13
Issue
6
Pages
e1002046
ISSN
  • 1549-1277 (ISSN-L)
  • 1549-1676
OpenAlex
W2472949758
Cited by
33
References
32
Citations by year
2026: 1 · 2025: 9 · 2024: 2 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 1 · 2019: 1 · 2018: 5 · 2017: 5 · 2016: 2
FWCI
5.45
Type
journal article
Language
en
Open access
Locations
  • PLoS Medicine (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • SERVAL (Université de Lausanne) (publishedVersion, other-oa)
  • Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, cc-by)
  • IRIS (submittedVersion)
  • Lirias (submittedVersion, cc-by)
  • RePEc: Research Papers in Economics (submittedVersion)
  • Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
  • Bern Open Repository and Information System (University of Bern) (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Figshare (submittedVersion, cc-by)
  • Työväentutkimus Vuosikirja (submittedVersion, other-oa)
  • Universidad de Chile (submittedVersion, cc-by-nc-nd)
  • Zurich Open Repository and Archive (University of Zurich) (submittedVersion, cc-by)
  • Zurich Open Repository and Archive (University of Zurich)
Funders
  • Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (320030_133540/1)
  • Deutsche Forschungsgemeinschaft (EL 544/1-2)
  • Santésuisse
  • Gottfried und Julia Bangerter-Rhyner-Stiftung
  • Young Investigators Award from Sichuan University, China (2013SCU04A37)
  • Fondation Brocher
  • New Investigator Award from the Canadian Institutes of Health Research and Canadian Chiropractic Research Foundation
  • Research Early Career Award from Hamilton Health Sciences Foundation (Jack Hirsh Fellowship)
  • Finnish Cultural Foundation and the Finnish Medical Foundation
  • Research Early Career Award from Hamilton Health Sciences
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
  • Social Sciences › Safety Research › Academic integrity and plagiarism
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
Keywords
publishing contracts, randomized controlled trials, publication rights, conflicts of interest, research ethics committees
MeSH terms
Authorship, Drug Industry, Periodicals as Topic, Publishing, Retrospective Studies, Randomized Controlled Trials as Topic

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