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. BusseIgnacio 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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article numbere1002046
JournalPLoS Medicine
Volume13
Issue number6
DOIs
Publication statusPublished - Jun 1 2016

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Publications
Industry
Randomized Controlled Trials
Retrospective Studies
Clinical Protocols
Personnel
Authorship
Manuscripts
Research Ethics Committees
Documentation

ASJC Scopus subject areas

  • Medicine(all)

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Agreements between Industry and Academia on Publication Rights : A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. / Kasenda, Benjamin; von Elm, Erik; 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; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Ferreira-González, 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.

In: PLoS Medicine, Vol. 13, No. 6, e1002046, 01.06.2016.

Research output: Contribution to journalArticle

Kasenda, B, von Elm, E, You, JJ, Blümle, A, Tomonaga, Y, Saccilotto, R, Amstutz, A, Bengough, T, Meerpohl, JJ, Stegert, M, Olu, KK, Tikkinen, KAO, Neumann, I, Carrasco-Labra, A, Faulhaber, M, Mulla, SM, Mertz, D, Akl, EA, Bassler, D, Busse, JW, Ferreira-González, I, Lamontagne, F, Nordmann, A, Gloy, V, Raatz, H, Moja, L, Ebrahim, S, Schandelmaier, S, Sun, X, Vandvik, PO, Johnston, BC, Walter, MA, Burnand, B, Schwenkglenks, M, Hemkens, LG, Bucher, HC, Guyatt, GH & 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, e1002046. https://doi.org/10.1371/journal.pmed.1002046
Kasenda, Benjamin ; von Elm, Erik ; 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 ; Carrasco-Labra, Alonso ; Faulhaber, Markus ; Mulla, Sohail M. ; Mertz, Dominik ; Akl, Elie A. ; Bassler, Dirk ; Busse, Jason W. ; Ferreira-González, 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. / Agreements between Industry and Academia on Publication Rights : A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. In: PLoS Medicine. 2016 ; Vol. 13, No. 6.
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title = "Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials",
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.",
author = "Benjamin Kasenda and {von Elm}, Erik and You, {John J.} and Anette Bl{\"u}mle and Yuki Tomonaga and Ramon Saccilotto and Alain Amstutz and Theresa Bengough and Meerpohl, {Joerg J.} and Mihaela Stegert and Olu, {Kelechi K.} and Tikkinen, {Kari A O} and Ignacio Neumann and Alonso Carrasco-Labra and Markus Faulhaber and Mulla, {Sohail M.} and Dominik Mertz and Akl, {Elie A.} and Dirk Bassler and Busse, {Jason W.} and Ignacio Ferreira-Gonz{\'a}lez and Francois Lamontagne and Alain Nordmann and Viktoria Gloy and Heike Raatz and Lorenzo Moja and Shanil Ebrahim and Stefan Schandelmaier and Xin Sun and Vandvik, {Per O.} and Johnston, {Bradley C.} and Walter, {Martin A.} and Bernard Burnand and Matthias Schwenkglenks and Hemkens, {Lars G.} and Bucher, {Heiner C.} and Guyatt, {Gordon H.} and Matthias Briel",
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T1 - Agreements between Industry and Academia on Publication Rights

T2 - A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

AU - Kasenda, Benjamin

AU - von Elm, Erik

AU - You, John J.

AU - Blümle, Anette

AU - Tomonaga, Yuki

AU - Saccilotto, Ramon

AU - Amstutz, Alain

AU - Bengough, Theresa

AU - Meerpohl, Joerg J.

AU - Stegert, Mihaela

AU - Olu, Kelechi K.

AU - Tikkinen, Kari A O

AU - Neumann, Ignacio

AU - Carrasco-Labra, Alonso

AU - Faulhaber, Markus

AU - Mulla, Sohail M.

AU - Mertz, Dominik

AU - Akl, Elie A.

AU - Bassler, Dirk

AU - Busse, Jason W.

AU - Ferreira-González, Ignacio

AU - Lamontagne, Francois

AU - Nordmann, Alain

AU - Gloy, Viktoria

AU - Raatz, Heike

AU - Moja, Lorenzo

AU - Ebrahim, Shanil

AU - Schandelmaier, Stefan

AU - Sun, Xin

AU - Vandvik, Per O.

AU - Johnston, Bradley C.

AU - Walter, Martin A.

AU - Burnand, Bernard

AU - Schwenkglenks, Matthias

AU - Hemkens, Lars G.

AU - Bucher, Heiner C.

AU - Guyatt, Gordon H.

AU - Briel, Matthias

PY - 2016/6/1

Y1 - 2016/6/1

N2 - 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.

AB - 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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DO - 10.1371/journal.pmed.1002046

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