Impact of industry funding on atrial fibrillation clinical trials: insights and implications

Abstract

Abstract Background/Introduction Commercial industry is an important source of funding for atrial fibrillation clinical trials, the implications of which have not been analyzed. Purpose The purpose of this study is to describe the characteristics of contemporary AF clinical trials and to evaluate their association with funding source. Methods We systematically assessed all completed atrial fibrillation trials registered in ClinicalTrials.gov between conception to September 1, 2022, and extracted publicly available information including funding source, trial size, race, ethnicity, sex, intervention, location, and publication status. Trial characteristics were compared using the Wilcoxon rank sum test and Fisher’s exact test for continuous and categorical variables, respectively. Results Of the 253 clinical trials assessed, 171 (68%) reported industry funding. Industry funding was associated with a greater median total enrollment (172 vs. 80; P < 0.001), publication rate (56.7% vs. 42.7%; P = 0.04), participation in device trials (48.0% vs. 24.4%; P < 0.001), and multicontinental recruitment location (25.2% vs. 2.4%; P < 0.001) when compared to non-industry funded clinical trials. However, industry funding was not associated with a significant difference in median impact factor (7.7 vs. 7.7; P = 0.723) or median number of citations (60.0 vs. 29.0; P = 0.09). The overall proportion of industry funded trials did not change over time (P = 1.00) since inception of the ClinicalTrials.gov database. Participant demographics remained relatively uniform over time across both industry-funded and non-industry-funded trials. Conclusion(s). Industry funded clinical trials in atrial fibrillation are often larger, more frequently published, multicontinental, and device-focused. Industry funding was found to be associated with significant differences in study enrollment, publication metrics, and study interventions. Insights from this study inform trial design, regulation, and policy considerations in the evolving landscape of AF research.TableFigure