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

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dc.contributor University of Helsinki, HUS Abdominal Center en
dc.contributor.author Kasenda, Benjamin
dc.contributor.author von Elm, Erik
dc.contributor.author You, John J.
dc.contributor.author Bluemle, Anette
dc.contributor.author Tomonaga, Yuki
dc.contributor.author Saccilotto, Ramon
dc.contributor.author Amstutz, Alain
dc.contributor.author Bengough, Theresa
dc.contributor.author Meerpohl, Joerg J.
dc.contributor.author Stegert, Mihaela
dc.contributor.author Olu, Kelechi K.
dc.contributor.author Tikkinen, Kari A. O.
dc.contributor.author Neumann, Ignacio
dc.contributor.author Carrasco-Labra, Alonso
dc.contributor.author Faulhaber, Markus
dc.contributor.author Mulla, Sohail M.
dc.contributor.author Mertz, Dominik
dc.contributor.author Akl, Elie A.
dc.contributor.author Bassler, Dirk
dc.contributor.author Busse, Jason W.
dc.contributor.author Ferreira-Gonzalez, Ignacio
dc.contributor.author Lamontagne, Francois
dc.contributor.author Nordmann, Alain
dc.contributor.author Gloy, Viktoria
dc.contributor.author Raatz, Heike
dc.contributor.author Moja, Lorenzo
dc.contributor.author Ebrahim, Shanil
dc.contributor.author Schandelmaier, Stefan
dc.contributor.author Sun, Xin
dc.contributor.author Vandvik, Per O.
dc.contributor.author Johnston, Bradley C.
dc.contributor.author Walter, Martin A.
dc.contributor.author Burnand, Bernard
dc.contributor.author Schwenkglenks, Matthias
dc.contributor.author Hemkens, Lars G.
dc.contributor.author Bucher, Heiner C.
dc.contributor.author Guyatt, Gordon H.
dc.contributor.author Briel, Matthias
dc.date.accessioned 2016-07-28T10:08:01Z
dc.date.available 2016-07-28T10:08:01Z
dc.date.issued 2016-06
dc.identifier.citation Kasenda , B , von Elm , E , You , J J , Bluemle , 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-Gonzalez , 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 2016 , ' Agreements between Industry and Academia on Publication Rights : A Retrospective Study of Protocols and Publications of Randomized Clinical Trials ' , PLoS Medicine , vol. 13 , no. 6 , 1002046 . https://doi.org/10.1371/journal.pmed.1002046 en
dc.identifier.issn 1549-1676
dc.identifier.other PURE: 66560619
dc.identifier.other PURE UUID: 5a90eaf4-94b2-43f2-bf2d-671137c56a5c
dc.identifier.other WOS: 000379128200019
dc.identifier.other Scopus: 84978140764
dc.identifier.other ORCID: /0000-0002-1389-8214/work/52696102
dc.identifier.uri http://hdl.handle.net/10138/164997
dc.description.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. en
dc.format.extent 14
dc.language.iso eng
dc.relation.ispartof PLoS Medicine
dc.rights en
dc.subject CONFLICTS-OF-INTEREST en
dc.subject MEDICAL-CENTERS en
dc.subject REPORTING BIAS en
dc.subject INVESTIGATORS en
dc.subject AUTHORSHIP en
dc.subject SPONSORS en
dc.subject OUTCOMES en
dc.subject 3121 General medicine, internal medicine and other clinical medicine en
dc.title Agreements between Industry and Academia on Publication Rights : A Retrospective Study of Protocols and Publications of Randomized Clinical Trials en
dc.type Article
dc.description.version Peer reviewed
dc.identifier.doi https://doi.org/10.1371/journal.pmed.1002046
dc.type.uri info:eu-repo/semantics/other
dc.type.uri info:eu-repo/semantics/publishedVersion
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