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 language | English |
|---|---|
| Article number | e1002046 |
| Journal | PLoS Medicine |
| Volume | 13 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Jun 1 2016 |
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ASJC Scopus subject areas
- Medicine(all)
Cite this
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 journal › Article
}
TY - JOUR
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.
UR - http://www.scopus.com/inward/record.url?scp=84978140764&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84978140764&partnerID=8YFLogxK
U2 - 10.1371/journal.pmed.1002046
DO - 10.1371/journal.pmed.1002046
M3 - Article
AN - SCOPUS:84978140764
VL - 13
JO - PLoS Medicine
JF - PLoS Medicine
SN - 1549-1277
IS - 6
M1 - e1002046
ER -