Department of Medicine, Stanford University School of Medicine, Stanford, California.
Department of Cardiology, Texas Heart Institute, Houston, Texas; Center for Cardiac Arrhythmias and Electrophysiology, Texas Heart Institute, Houston, Texas.
Heart Rhythm. 2024 Sep;21(9):1517-1523. doi: 10.1016/j.hrthm.2024.03.001. Epub 2024 Mar 6.
Industry sponsorship is an important source of funding for atrial fibrillation (AF) clinical trials, the implications of which have not been analyzed.
The purpose of this study was to determine the characteristics of contemporary AF clinical trials and to evaluate their association with funding source.
We systematically assessed all completed AF trials registered in the ClinicalTrials.gov database between conception to October 31, 2023, and extracted publicly available information including funding source, trial size, demographic distribution, intervention, location, and publication status. Trial characteristics were compared using the Wilcoxon rank-sum test and Fisher exact test for continuous and categorical variables, respectively.
Of the 253 clinical trials assessed, 171 (68%) reported industry funding. Industry funding was associated with a greater median number of patients enrolled (172 vs 80; P <.001), publication rate (56.7% vs 42.7%; P = .04), probability of being product-focused (48.0% vs 24.4%; P <.001), and multicontinental recruitment location (25.2% vs 2.4%; P <.001) when compared to nonindustry-funded trials. However, industry funding was not associated with a significant difference in median impact factor (7.7 vs 7.7; P = .723). The overall proportion of industry-funded trials did not change over time (P = 1).
Industry-funded clinical trials in AF often are larger, more frequently published, multicontinental, and product-focused. Industry funding was found to be associated with significant differences in study enrollment and publication metrics.
产业赞助是房颤（AF）临床试验的重要资金来源，其影响尚未得到分析。
本研究旨在确定当代 AF 临床试验的特征，并评估其与资金来源的关系。
我们系统评估了 2023 年 10 月 31 日之前在 ClinicalTrials.gov 数据库中注册的所有已完成的 AF 试验，并提取了公开可用的信息，包括资金来源、试验规模、人口统计学分布、干预措施、地点和出版状态。使用 Wilcoxon 秩和检验和 Fisher 确切检验分别比较试验特征的连续性和分类变量。
在评估的 253 项临床试验中，有 171 项（68%）报告了产业资金。与非产业资助试验相比，产业资助与纳入的患者中位数数量更多（172 比 80；P <.001）、发表率更高（56.7%比 42.7%；P =.04）、产品重点概率更高（48.0%比 24.4%；P <.001）和多大陆招募地点（25.2%比 2.4%；P <.001）有关。然而，产业资助与中位数影响因子（7.7 比 7.7；P =.723）之间没有显著差异。随着时间的推移，产业资助试验的总体比例没有变化（P = 1）。
在 AF 中，产业资助的临床试验通常规模更大、更频繁地发表、多大陆和产品重点。产业资助与研究纳入和发表指标的显著差异有关。
