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Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials
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نویسنده
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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.
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منبع
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plos medicine - 2016 - دوره : 13 - شماره : 6
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چکیده
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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. © 2016 kasenda et al.
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آدرس
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basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel, Switzerland, cochrane switzerland,institute of social and preventive medicine (iumsp),lausanne university hospital,lausanne, Switzerland, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,department of medicine,mcmaster university,hamilton,on, Canada, cochrane germany,university of freiburg,freiburg, Germany, epidemiology,biostatistics and prevention institute (ebpi),university of zurich,zurich, Switzerland, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel, Switzerland, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel, Switzerland, cochrane switzerland,institute of social and preventive medicine (iumsp),lausanne university hospital,lausanne,switzerland,austrian federal institute for health care,department of health and society,vienna, Austria, cochrane germany,university of freiburg,freiburg, Germany, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel, Switzerland, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel, Switzerland, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,departments of urology and public health,helsinki university hospital and university of helsinki,helsinki, Finland, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,department of internal medicine,pontificia universidad católica de chile,santiago, Chile, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,evidence-based dentistry unit,faculty of dentistry,universidad de chile,santiago, Chile, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on, Canada, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on, Canada, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,department of medicine,mcmaster university,hamilton,on,canada,michael g. degroote institute for infectious disease research,mcmaster university,hamilton,on, Canada, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,department of internal medicine,american university of beirut,beirut,lebanon,department of medicine,state university of new york at buffalo,buffalo,ny, United States, department of neonatology,university hospital of zurich,zurich, Switzerland, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,michael g. degroote institute for pain research and care,mcmaster university,hamilton,on,canada,department of anesthesia,mcmaster university,hamilton,on, Canada, epidemiology unit,department of cardiology,vall d’hebron hospital and centro de investigación biomédica en red de epidemiología y salud publica (ciberesp),barcelona, Spain, centre de recherche clinique étienne-le bel and department of medicine,université de sherbrooke,sherbrooke,qc, Canada, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel, Switzerland, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel,switzerland,institute of nuclear medicine,university hospital of bern,bern, Switzerland, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel, Switzerland, irccs orthopedic institute galeazzi,milan, Italy, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,michael g. degroote institute for pain research and care,mcmaster university,hamilton,on,canada,department of anesthesia,mcmaster university,hamilton,on,canada,stanford prevention research center,stanford university,stanford,ca, United States, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel,switzerland,academy of swiss insurance medicine,university hospital of basel,basel, Switzerland, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,chinese evidence-based medicine center,west china hospital,sichuan university,chengdu, China, department of medicine,innlandet hospital trust–division gjøvik,oppland, Norway, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,institute of health policy,management and evaluation,university of toronto,toronto,on,canada,department of anesthesia and pain medicine,hospital for sick children,toronto,on, Canada, institute of nuclear medicine,university hospital of bern,bern, Switzerland, cochrane switzerland,institute of social and preventive medicine (iumsp),lausanne university hospital,lausanne, Switzerland, epidemiology,biostatistics and prevention institute (ebpi),university of zurich,zurich, Switzerland, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel, Switzerland, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel, Switzerland, department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on,canada,department of medicine,mcmaster university,hamilton,on, Canada, basel institute for clinical epidemiology and biostatistics,university hospital of basel,basel,switzerland,department of clinical epidemiology and biostatistics,mcmaster university,hamilton,on, Canada
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