Collaboration between academics and industry in clinical trials: cross-sectional study of publications and survey of lead academic authors

Session: 

Oral session: Investigating bias (1)

Date: 

Sunday 16 September 2018 - 16:20 to 16:40

Location: 

Sidlaw Auditorium

All authors in correct order:

Rasmussen K1, Bero L2, Redberg R3, Gøtzsche P1, Lundh A4
1 Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark
2 Charles Perkins Centre and Faculty of Pharmacy, University of Sydney, Australia
3 UCSF Division of Cardiology, San Francisco, California, USA
4 Center for Evidence-Based Medicine, Odense University Hospital and University of Southern Denmark, Denmark
Presenting author and contact person

Presenting author:

Kristine Rasmussen

Contact person:

Kristine Rasmussen
Abstract text
Background: Most clinical trials are industry-funded. Industry-funded trials are typically conducted in collaboration with academics who may run the trial independently from the industry funder or conversely play a minimal role but are involved to give the trial credibility.
Objective: To determine the role of academic authors, funders and contract research organisations in industry-funded vaccine, drug and device trials, and to determine lead academic authors’ experiences with industry-funder collaborations.
Methods: Cross-sectional analysis of trial publications and survey of lead academic authors. We included the most recent 200 vaccine, drug and device trials with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals.
Results: We found 183 (92%) trials reported funder involvement in design, 146 (73%) in data analysis and 173 (87%) in reporting of the trial.
Eighty of the 200 lead academic authors (40%) responded to the survey. Twenty-nine (33%) of the 80 responders reported that academics solely had final say on the design while 43 (54%) reported the funder was involved in the final decision on the design (Figure 1). The data analysis was conducted solely by funder and/or contract research organisation in 33 (41%) of the trials. Seven (9%) responders reported an unnamed funder or contract research organisation employee did the data analysis and five (6%) that reported an unnamed funder or contract research organisation employee drafted the manuscript. Most academic authors found the collaboration with industry funder beneficial and reported the funding, prestige and high impact journal publications as important benefits. However, three (4%) experienced delay in publication due to the industry funder and nine (11%) reported disagreements with the industry funder mostly over trial design and reporting.
Conclusions: Industry funders had influence on design, analysis and reporting in most industry-funded trials. Some lead academic authors reported that not all industry funder employees were named despite having importing roles. Academics viewed the collaboration as beneficial, but some reported loss of academic freedom.
Patient or healthcare consumer involvement: Patients were not involved in this study, but we plan to involve patients in the dissemination of our findings.

Attachments: 

PDF icon Figure 1 Collaboration between academics and industry.pdf

Relevance to patients and consumers: 

This study is relevant to all patients and healthcare consumers as it addresses the lack of independence from industry funders in clinical trials. Patients involved in clinical trials take a risk when participating in a trial and deserve to have the role of collaborators published in a transparent fashion. Furthermore, the motives for academic participation in industry-funded trials may be important for patients and consumers.