Collaboration between academics and industry in clinical trials: cross sectional study of publications and survey of lead academic authorsBMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k3654 (Published 03 October 2018) Cite this as: BMJ 2018;363:k3654
- Kristine Rasmussen, researcher1,
- Lisa Bero, professor2,
- Rita Redberg, professor3,
- Peter C Gøtzsche, professor1,
- Andreas Lundh, senior researcher4
- 1Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark
- 2Charles Perkins Centre and Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia
- 3UCSF Division of Cardiology, San Francisco, CA, USA
- 4Centre for Evidence-Based Medicine Odense (CEBMO) and Odense Patient data Exploratory Network (OPEN), Odense University Hospital, Odense, Denmark
- 5Department of Clinical Research, University of Southern Denmark, Odense, Denmark
- 6Department of Infectious Diseases, Hvidovre Hospital, Hvidovre, Denmark
- Correspondence to: K Rasmussen
- Accepted 30 July 2018
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.
Contributors: KR had the idea for the study and developed the protocol with contributions from all authors. KR and AL extracted data and analysed the results. KR drafted the manuscript. All authors interpreted results, were involved in the reporting of the study, and approved the final version of the manuscript. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. KR is the guarantor; she accepts full responsibility for the work and the conduct of the study, had access to the data, and controlled the decision to publish.
Funding: No external funding received. Study was financed by institutional salaries.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; RFR is editor of JAMA Internal Medicine, which is included in the sample of journals, but had no role in data extraction or analysis of the results; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The Regional Committee on Health Research Ethics and the Danish Data Protection Agency both confirmed that this survey does not require any form of approval according to Danish law.
Transparency statement: The manuscript's guarantor affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as originally planned (and, if relevant, registered) have been explained.
Data sharing: Anonymised data are available on request.
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