Abstract
Collaboration Between Industry and Academics in Clinical Vaccine, Drug, and Device Trials: A Survey of Academic Investigators
Kristine Rasmussen,1,2 Lisa A. Bero,3 Rita Redberg,4 Peter C. Gøtzsche,1 Andreas Lundh5,6
Objective
Collaboration between academic investigators and industry may constrain academic freedom. This study aims to determine the level of influence that academic investigators and funders have on industry-funded vaccine, drug, and device trials from design to publication, and to determine whether investigators report any problems with the collaboration.
Design
We conducted a survey of lead academic authors. We included the most recent 200 trials meeting our inclusion criteria. These were phase 3 and 4 vaccine, drug, and device trials with sole industry sponsorship, at least 1 academic author, and published in 1 of the top 7 high-impact general medical journals (ie, NEJM, Lancet, JAMA, BMJ, Annals of Internal Medicine, JAMA Internal Medicine, and PLoS Medicine). We searched the journals on March 26, 2017. Two authors (A.L. and K.R.) independently extracted data on trial characteristics from the included publications, including the role of academic authors, funders, and contract research organizations. A pilot tested survey was emailed to lead academic authors. Questions were designed to ascertain who undertook each stage of the trial, whether disagreements arose with the funder at any decision point, and who ultimately had control over trial design, conduct, analysis, reporting, and publication. We analyzed the survey data descriptively and compared information reported in trial publications with survey responses.
Results
The 200 included trials were published between July 2014 and March 2017. We included trials from all selected journals except PLoS Medicine where no industry-funded trials met our inclusion criteria. Of the 200 articles analyzed, 176 (88%) were coauthored by industry funders. We found that 170 (85%) trials reported funder involvement in design and 152 (76%) academic author involvement, yet the funder’s and academic author’s involvement in the design was not mentioned at all in 9 (5%) publications. Statistical analysis involved the funder in 147 (74%) trials and the academic author in 97 (49%), but their involvement in the statistical analysis was not mentioned in 9 (5%) publications. Trial reporting involved the funder in 168 (84%) trials and academic authors in 191 (96%), yet their role in the reporting was not mentioned at all in 6 (3%). Contract research organizations were involved in the trial reporting in 114 (57%) publications. Survey results are being analyzed and will be presented.
Conclusions
In industry-funded trials published in high-impact journals, academic investigators are involved in the design and reporting of most clinical trials, but to a lesser degree in statistical analysis compared with industry funders.
1The Nordic Cochrane Center, Rigshospitalet, Copenhagen, Denmark, kristinersmssn@gmail.com; 2Department of Primary Care & Public Health, Imperial College London, London, UK; 3Charles Perkins Center and Faculty of Pharmacy, University of Sydney, Australia; 4UCSF Division of Cardiology, University of California, San Francisco School of Medicine, San Francisco, CA USA; 5Center for Evidence-Based Medicine, Odense University Hospital and University of Southern Denmark, Odense, Denmark; 6Department of Infectious Diseases, Hvidovre Hospital, Hvidovre, Denmark
Conflict of Interest Disclosures:
Lisa Bero and Peter C. Gøtzsche are members of the Peer Review Congress Advisory Board but were not involved in the review or decision for this abstract. No other conflicts are reported.