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

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.

Duke Scholars

Author Robert Theodore Tisherman Orthopaedic Surgery