Evidence map›Paper›PMID 27352244›Full record

ArticlePLoS medicine2016

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 and 28 more

Abstract read
In one paragraph

Article in PLoS medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Review
  3. Article
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  13. Cochrane in CORRClinical orthopaedics and related research · 2017
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

38 authors.

Benjamin KasendaBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Erik von ElmCochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
John J YouDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Anette BlümleCochrane Germany, University of Freiburg, Freiburg, Germany.ORCID 0000-0003-2877-1029
Yuki TomonagaEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.
Ramon SaccilottoBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Alain AmstutzBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Theresa BengoughCochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
Joerg J MeerpohlCochrane Germany, University of Freiburg, Freiburg, Germany.
Mihaela StegertBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Kelechi K OluBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Kari A O TikkinenDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Ignacio NeumannDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Alonso Carrasco-LabraDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Markus FaulhaberDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Sohail M MullaDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Dominik MertzDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Elie A AklDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Dirk BasslerDepartment of Neonatology, University Hospital of Zurich, Zurich, Switzerland.
Jason W BusseDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Ignacio Ferreira-GonzálezEpidemiology Unit, Department of Cardiology, Vall d'Hebron Hospital and Centro de Investigación Biomédica en Red de Epidemiología y Salud Publica (CIBERESP), Barcelona, Spain.ORCID 0000-0002-1208-5561
Francois LamontagneCentre de Recherche Clinique Étienne-Le Bel and Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.ORCID 0000-0002-0360-3427
Alain NordmannBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Viktoria GloyBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Heike RaatzBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.ORCID 0000-0001-7015-3465
Lorenzo MojaIRCCS Orthopedic Institute Galeazzi, Milan, Italy.ORCID 0000-0001-6680-6507
Shanil EbrahimDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Stefan SchandelmaierBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Xin SunDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Per O VandvikDepartment of Medicine, Innlandet Hospital Trust-Division Gjøvik, Oppland, Norway.
Bradley C JohnstonDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Martin A WalterInstitute of Nuclear Medicine, University Hospital of Bern, Bern, Switzerland.
Bernard BurnandCochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
Matthias SchwenkglenksEpidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.ORCID 0000-0001-7217-1173
Lars G HemkensBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Heiner C BucherBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.
Gordon H GuyattDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Matthias BrielBasel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland.

Funding

CIHR
6 · The paper itself

Abstract

backgroundLittle 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

findingsWe 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.

conclusionsPublication 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.

Indexed as

AuthorshipDrug IndustryPeriodicals as TopicPublishingRandomized Controlled Trials as TopicRetrospective Studies

Identifiers

PMID27352244
PMCPMC4924795

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.