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PLoS Med. 2016 Jun 28;13(6):e1002046. doi: 10.1371/journal.pmed.1002046. eCollection 2016 Jun.

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

Author information

1
Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
2
Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
3
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
4
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
5
Cochrane Germany, University of Freiburg, Freiburg, Germany.
6
Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.
7
Austrian Federal Institute for Health Care, Department of Health and Society, Vienna, Austria.
8
Departments of Urology and Public Health, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
9
Department of Internal Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.
10
Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile.
11
Michael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, Ontario, Canada.
12
Department of Internal Medicine, American University of Beirut, Beirut, Lebanon.
13
Department of Medicine, State University of New York at Buffalo, Buffalo, New York, United States of America.
14
Department of Neonatology, University Hospital of Zurich, Zurich, Switzerland.
15
Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada.
16
Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.
17
Epidemiology Unit, Department of Cardiology, Vall d'Hebron Hospital and Centro de Investigación Biomédica en Red de Epidemiología y Salud Publica (CIBERESP), Barcelona, Spain.
18
Centre de Recherche Clinique Étienne-Le Bel and Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.
19
Institute of Nuclear Medicine, University Hospital of Bern, Bern, Switzerland.
20
IRCCS Orthopedic Institute Galeazzi, Milan, Italy.
21
Stanford Prevention Research Center, Stanford University, Stanford, California, United States of America.
22
Academy of Swiss Insurance Medicine, University Hospital of Basel, Basel, Switzerland.
23
Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
24
Department of Medicine, Innlandet Hospital Trust-Division Gjøvik, Oppland, Norway.
25
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
26
Department of Anesthesia and Pain Medicine, Hospital for Sick Children, Toronto, Ontario, Canada.

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.

PMID:
27352244
PMCID:
PMC4924795
DOI:
10.1371/journal.pmed.1002046
[Indexed for MEDLINE]
Free PMC Article

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