Characteristics of contemporary atrial fibrillation clinical trials and their association with industry sponsorship

Heart Rhythm. 2024 Sep;21(9):1517-1523. doi: 10.1016/j.hrthm.2024.03.001. Epub 2024 Mar 6.

Abstract

Background: Industry sponsorship is an important source of funding for atrial fibrillation (AF) clinical trials, the implications of which have not been analyzed.

Objective: The purpose of this study was to determine the characteristics of contemporary AF clinical trials and to evaluate their association with funding source.

Methods: 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.

Results: 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).

Conclusion: 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.

Keywords: Disparities; Diversity; Equity; Funding; Industry.

Publication types

  • Meta-Analysis

MeSH terms

  • Atrial Fibrillation* / economics
  • Atrial Fibrillation* / therapy
  • Clinical Trials as Topic*
  • Drug Industry / economics
  • Humans
  • Research Support as Topic / economics