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

Show simple item record Kasenda, Benjamin von Elm, Erik You, John J. Bluemle, Anette Tomonaga, Yuki Saccilotto, Ramon Amstutz, Alain Bengough, Theresa Meerpohl, Joerg J. Stegert, Mihaela Olu, Kelechi K. Tikkinen, Kari A. O. Neumann, Ignacio Carrasco-Labra, Alonso Faulhaber, Markus Mulla, Sohail M. Mertz, Dominik Akl, Elie A. Bassler, Dirk Busse, Jason W. Ferreira-Gonzalez, Ignacio Lamontagne, Francois 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 2016-07-28T10:08:01Z 2016-07-28T10:08:01Z 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 .
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.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.uri info:eu-repo/semantics/openAccess
dc.subject AUTHORSHIP
dc.subject SPONSORS
dc.subject OUTCOMES
dc.subject 3121 General medicine, internal medicine and other clinical medicine
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.contributor.organization HUS Abdominal Center
dc.contributor.organization Urologian yksikkö
dc.contributor.organization Clinicum
dc.contributor.organization Department of Public Health
dc.description.reviewstatus Peer reviewed
dc.relation.issn 1549-1676
dc.rights.accesslevel openAccess
dc.type.version publishedVersion

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