Publication agreements constraining academic investigators' independence are common, and incompletely reported in publications, according to a study published in this week's PLOS Medicine. The study, conducted by Matthias Briel, University Hospital Basel, Switzerland, and colleagues, suggests that publication agreements may compromise the scientific evidence base established by randomized clinical trials.
Many randomized trials are designed and sponsored by for-profit companies that contract academic investigators to recruit and manage patients. Briel and colleagues sought to understand how these agreements might constrain publication of trial results. The researchers investigated publication agreements in 647 randomized trial protocols approved in 2000-2003 by six research ethics committees in Switzerland, Canada, and Germany, and the 388 corresponding journal publications. They found that 70% of protocols mentioned an agreement on publication rights between industry and academic investigators; in 86% of those agreements, industry retained the right to disapprove or at least review manuscripts before publication. 74% of agreements documented in protocols were not mentioned in corresponding journal articles.
Half of the included journal articles were published before 2008, leaving open the possibility that these findings do not reflect current practice. Nonetheless, the findings suggest that more transparency on publication constraints is warranted. The authors state, "[c]linical research under these circumstances is a business transaction that bears the potential for conflicts of interest, including those regarding the publication of trial results."
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Research Article
Funding:
This study was funded by the Swiss National Science Foundation (grant 320030_133540/1) and the German Research Foundation (grant EL 544/1-2). MB, AN, VG, HR, LGH, and HCB are supported by Santésuisse and the Gottfried and Julia Bangerter-Rhyner-Foundation. XS is supported by a Young Investigators Award (2013SCU04A37) from Sichuan University, China. During study preparation, EvE was supported by the Brocher Foundation. JWB is funded by a New Investigator Award from the Canadian Institutes of Health Research and Canadian Chiropractic Research Foundation. DM is a recipient of a Research Early Career Award from Hamilton Health Sciences Foundation (Jack Hirsh Fellowship). KAOT is funded by unrestricted grants from the Finnish Cultural Foundation and the Finnish Medical Foundation. JY is supported by a Research Early Career Award from Hamilton Health Sciences. No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests:
The authors have declared that no competing interests exist.
Citation:
Kasenda B, von Elm E, You JJ, Blümle A, Tomonaga Y, Saccilotto R, et al. (2016) Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PLoS Med 13(6): e1002046. doi:10.1371/journal.pmed.1002046
Author Affiliations:
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, Ontario, Canada
Department of Medicine, McMaster University, Hamilton, Ontario, Canada
Cochrane Germany, University of Freiburg, Freiburg, Germany
Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland
Austrian Federal Institute for Health Care, Department of Health and Society, Vienna, Austria
Departments of Urology and Public Health, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Department of Internal Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile
Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile
Michael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, Ontario, Canada
Department of Internal Medicine, American University of Beirut, Beirut, Lebanon
Department of Medicine, State University of New York at Buffalo, Buffalo, New York, United States of America
Department of Neonatology, University Hospital of Zurich, Zurich, Switzerland
Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada
Department of Anesthesia, McMaster University, Hamilton, Ontario, 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, Quebec, Canada
Institute of Nuclear Medicine, University Hospital of Bern, Bern, Switzerland
IRCCS Orthopedic Institute Galeazzi, Milan, Italy
Stanford Prevention Research Center, Stanford University, Stanford, California, United States of America
Academy of Swiss Insurance Medicine, University Hospital of Basel, Basel, Switzerland
Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China
Department of Medicine, Innlandet Hospital Trust-Division Gjøvik, Oppland, Norway
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
Department of Anesthesia and Pain Medicine, Hospital for Sick Children, Toronto, Ontario, Canada
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Contact:
Matthias Briel, MD
Deputy Director
Institute for Clinical Epidemiology and Biostatistics
Department of Clinical Research
University Hospital Basel
Spitalstrasse 12
CH-4031 Basel
SWITZERLAND
+41 (0)61 3285092
matthias.briel@usb.ch
Journal
PLoS Medicine