Article type
Year
Abstract
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.
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.