Collaboration between academics and industry in clinical trials

cross sectional study of publications and survey of lead academic authors

Kristine Rasmussen, Lisa Bero, Rita Redberg, Peter C Gøtzsche, Andreas Lundh

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Resumé

OBJECTIVES: To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors' experiences with industry funder collaborations.

DESIGN: Cross sectional analysis of trial publications and survey of lead academic authors.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES: The most recent 200 phase III and IV trials of vaccines, drugs, and devices with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals (New England Journal of Medicine, Lancet, JAMA, BMJ, Annals of Internal Medicine, JAMA Internal Medicine, and PLoS Medicine).

RESULTS: Employees of industry funders co-authored 173 (87%) of publications; 183 (92%) trials reported involvement of funders in design, and 167 (84%) reported involvement of academic authors. Data analysis involved the funder in 146 (73%) trials and the academic authors in 79 (40%). Trial reporting involved the funder in 173 (87%) trials and academic authors in 197 (99%). Contract research organisations were involved in the reporting of 123 (62%) trials.Eighty (40%) of 200 lead academic authors responded to the survey. Twenty nine (33%) of the 80 responders reported that academics had final say on the design. Ten responders described involvement of an unnamed funder and/or contract research organisation employee in the data analysis and/or reporting. Most academic authors found the collaboration with industry funder beneficial, but 3 (4%) experienced delay in publication due to the industry funder and 9 (11%) reported disagreements with the industry funder, mostly concerning trial design and reporting.

CONCLUSIONS: Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement. Academics view the collaboration as beneficial, but some report loss of academic freedom.

OriginalsprogEngelsk
Artikelnummerk3654
TidsskriftB M J
Vol/bind363
Antal sider9
ISSN0959-8146
DOI
StatusUdgivet - 3. okt. 2018

Fingeraftryk

Publications
Cross-Sectional Studies
Clinical Trials
Organizations
Internal Medicine
Research
Medicine
Equipment and Supplies
New England
Pharmaceutical Preparations
Research Design

Citer dette

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title = "Collaboration between academics and industry in clinical trials: cross sectional study of publications and survey of lead academic authors",
abstract = "OBJECTIVES: To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors' experiences with industry funder collaborations.DESIGN: Cross sectional analysis of trial publications and survey of lead academic authors.ELIGIBILITY CRITERIA FOR SELECTING STUDIES: The most recent 200 phase III and IV trials of vaccines, drugs, and devices with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals (New England Journal of Medicine, Lancet, JAMA, BMJ, Annals of Internal Medicine, JAMA Internal Medicine, and PLoS Medicine).RESULTS: Employees of industry funders co-authored 173 (87{\%}) of publications; 183 (92{\%}) trials reported involvement of funders in design, and 167 (84{\%}) reported involvement of academic authors. Data analysis involved the funder in 146 (73{\%}) trials and the academic authors in 79 (40{\%}). Trial reporting involved the funder in 173 (87{\%}) trials and academic authors in 197 (99{\%}). Contract research organisations were involved in the reporting of 123 (62{\%}) trials.Eighty (40{\%}) of 200 lead academic authors responded to the survey. Twenty nine (33{\%}) of the 80 responders reported that academics had final say on the design. Ten responders described involvement of an unnamed funder and/or contract research organisation employee in the data analysis and/or reporting. Most academic authors found the collaboration with industry funder beneficial, but 3 (4{\%}) experienced delay in publication due to the industry funder and 9 (11{\%}) reported disagreements with the industry funder, mostly concerning trial design and reporting.CONCLUSIONS: Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement. Academics view the collaboration as beneficial, but some report loss of academic freedom.",
author = "Kristine Rasmussen and Lisa Bero and Rita Redberg and G{\o}tzsche, {Peter C} and Andreas Lundh",
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Collaboration between academics and industry in clinical trials : cross sectional study of publications and survey of lead academic authors. / Rasmussen, Kristine; Bero, Lisa; Redberg, Rita; Gøtzsche, Peter C; Lundh, Andreas.

I: B M J, Bind 363, k3654, 03.10.2018.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Collaboration between academics and industry in clinical trials

T2 - cross sectional study of publications and survey of lead academic authors

AU - Rasmussen, Kristine

AU - Bero, Lisa

AU - Redberg, Rita

AU - Gøtzsche, Peter C

AU - Lundh, Andreas

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2018/10/3

Y1 - 2018/10/3

N2 - OBJECTIVES: To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors' experiences with industry funder collaborations.DESIGN: Cross sectional analysis of trial publications and survey of lead academic authors.ELIGIBILITY CRITERIA FOR SELECTING STUDIES: The most recent 200 phase III and IV trials of vaccines, drugs, and devices with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals (New England Journal of Medicine, Lancet, JAMA, BMJ, Annals of Internal Medicine, JAMA Internal Medicine, and PLoS Medicine).RESULTS: Employees of industry funders co-authored 173 (87%) of publications; 183 (92%) trials reported involvement of funders in design, and 167 (84%) reported involvement of academic authors. Data analysis involved the funder in 146 (73%) trials and the academic authors in 79 (40%). Trial reporting involved the funder in 173 (87%) trials and academic authors in 197 (99%). Contract research organisations were involved in the reporting of 123 (62%) trials.Eighty (40%) of 200 lead academic authors responded to the survey. Twenty nine (33%) of the 80 responders reported that academics had final say on the design. Ten responders described involvement of an unnamed funder and/or contract research organisation employee in the data analysis and/or reporting. Most academic authors found the collaboration with industry funder beneficial, but 3 (4%) experienced delay in publication due to the industry funder and 9 (11%) reported disagreements with the industry funder, mostly concerning trial design and reporting.CONCLUSIONS: Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement. Academics view the collaboration as beneficial, but some report loss of academic freedom.

AB - OBJECTIVES: To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors' experiences with industry funder collaborations.DESIGN: Cross sectional analysis of trial publications and survey of lead academic authors.ELIGIBILITY CRITERIA FOR SELECTING STUDIES: The most recent 200 phase III and IV trials of vaccines, drugs, and devices with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals (New England Journal of Medicine, Lancet, JAMA, BMJ, Annals of Internal Medicine, JAMA Internal Medicine, and PLoS Medicine).RESULTS: Employees of industry funders co-authored 173 (87%) of publications; 183 (92%) trials reported involvement of funders in design, and 167 (84%) reported involvement of academic authors. Data analysis involved the funder in 146 (73%) trials and the academic authors in 79 (40%). Trial reporting involved the funder in 173 (87%) trials and academic authors in 197 (99%). Contract research organisations were involved in the reporting of 123 (62%) trials.Eighty (40%) of 200 lead academic authors responded to the survey. Twenty nine (33%) of the 80 responders reported that academics had final say on the design. Ten responders described involvement of an unnamed funder and/or contract research organisation employee in the data analysis and/or reporting. Most academic authors found the collaboration with industry funder beneficial, but 3 (4%) experienced delay in publication due to the industry funder and 9 (11%) reported disagreements with the industry funder, mostly concerning trial design and reporting.CONCLUSIONS: Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement. Academics view the collaboration as beneficial, but some report loss of academic freedom.

U2 - 10.1136/bmj.k3654

DO - 10.1136/bmj.k3654

M3 - Journal article

VL - 363

JO - B M J

JF - B M J

SN - 0959-8146

M1 - k3654

ER -