Association Between Industry Sponsorship of Spine-Related Clinical Trials, Publication Status, and Research Outcomes

• Published in: Global spine journal Vol. 14; no. 7; pp. 2039 - 2044
• Main Authors: Munsch, Maria A., Chen, Stephen R., Dalton, Jonathan, Tisherman, Robert, Shaw, Jeremy D., Lee, Joon Y.
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.09.2024; Sage Publications Ltd
• Subjects: Back surgery; Clinical trials; Funding; Original; spondylitis; spondylosis; cervical, lumbar
• ISSN: 2192-5682; 2192-5690
• DOI: 10.1177/21925682231166379

Study Design Observational Database Study. Objectives Prospective clinical trials in spinal surgery are expensive to conduct, especially when randomized, appropriately powered, and/or multicentered. Industry collaborations generate symbiotic relationships promoting technological advancement; however, they also allow for bias. To the authors’ knowledge, there is no known analysis of correlations between industry sponsorship and publication rates of spine-related clinical trials. This observational work evaluates such potential associations. Methods The ClinicalTrials.gov database was queried with terms spine, spinal, spondylosis, spondylolysis, cervical, lumbar, and compression fracture over an 11-year period. Design characteristics and outcomes were recorded from 822 spine surgery-related trials. Trials were stratified based on funding source and intervention class. Groups were compared via two-tailed chi-square test of independence or Fisher’s exact test (α = .05), based on completion status and publication rates of positive vs negative results. Results Industry-sponsored spine-related clinical trials were more likely to be terminated than their non-industry-sponsored counterparts (P < .001). Of the trials achieving publication, industry-sponsored trials reported positive results at a higher rate than did trials without industry funding (P = .037). Clinical trials examining devices were more likely to be terminated than those studying other intervention classes (P = .001). Conclusions High termination rates and positive result publication rates among industry-sponsored clinical trials in spinal surgery likely reflect industry’s influence on the research community. Such partnership alleviates financial burden and provides accessibility to cutting-edge innovation. It is essential that all parties remain mindful of the significant bias that funding source may impart on study outcome.