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

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS
ACS Applied Bio Materials Pub Date : 2024-09-01 Epub Date: 2023-05-02 DOI:10.1177/21925682231166379
Maria A Munsch, Stephen R Chen, Jonathan Dalton, Robert Tisherman, Jeremy D Shaw, Joon Y Lee
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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.

脊柱相关临床试验的行业赞助、出版状况与研究结果之间的关联。
研究设计观察性数据库研究:脊柱外科的前瞻性临床试验耗资巨大,尤其是在随机、适当授权和/或多中心的情况下。行业合作会产生促进技术进步的共生关系,但也会产生偏差。据作者所知,目前还没有关于行业赞助与脊柱相关临床试验发表率之间相关性的分析。本观察性研究对这种潜在的关联性进行了评估:方法:在 11 年间,以脊椎、脊柱、脊柱炎、脊柱溶解症、颈椎病、腰椎病和压缩性骨折等术语对 ClinicalTrials.gov 数据库进行了查询。记录了 822 项脊柱手术相关试验的设计特征和结果。根据资金来源和干预等级对试验进行了分层。根据完成情况以及阳性结果与阴性结果的发表率,通过双尾独立卡方检验或费雪精确检验(α = .05)对各组进行比较:结果:与非行业资助的临床试验相比,行业资助的脊柱相关临床试验更有可能被终止(P < .001)。在发表论文的试验中,行业资助的试验报告阳性结果的比例高于非行业资助的试验(P = .037)。与研究其他干预类别的试验相比,研究器械的临床试验更容易被终止(P = .001):行业资助的脊柱外科临床试验的高终止率和阳性结果发表率可能反映了行业对研究界的影响。这种合作关系减轻了经济负担,并提供了获得尖端创新成果的机会。重要的是,所有各方都应始终牢记,资金来源可能会对研究结果产生重大偏差。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
自引率
2.10%
发文量
464
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