Maria A Munsch, Stephen R Chen, Jonathan Dalton, Robert Tisherman, Jeremy D Shaw, Joon Y Lee
{"title":"Association Between Industry Sponsorship of Spine-Related Clinical Trials, Publication Status, and Research Outcomes.","authors":"Maria A Munsch, Stephen R Chen, Jonathan Dalton, Robert Tisherman, Jeremy D Shaw, Joon Y Lee","doi":"10.1177/21925682231166379","DOIUrl":null,"url":null,"abstract":"<p><strong>Study design: </strong>Observational Database Study.</p><p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>The ClinicalTrials.gov database was queried with terms <i>spine</i>, <i>spinal</i>, <i>spondylosis</i>, <i>spondylolysis</i>, <i>cervical</i>, <i>lumbar</i>, and <i>compression fracture</i> 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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":2,"journal":{"name":"ACS Applied Bio Materials","volume":null,"pages":null},"PeriodicalIF":4.6000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11418736/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Bio Materials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/21925682231166379","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/5/2 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"MATERIALS SCIENCE, BIOMATERIALS","Score":null,"Total":0}
引用次数: 0
Abstract
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.