Inequities in atrial fibrillation trials: An analysis of participant race, ethnicity, and sex over time

Abstract

Background

Despite the importance of racial and ethnic representation in clinical trials, limited data exist about the enrollment trends of these groups in atrial fibrillation (AF) trials over time.

Objective

The purpose of this study was to examine the characteristics of contemporary AF clinical trials and to evaluate their association with race and ethnicity over time.

Methods

We performed a systematic search of all completed AF trials registered in ClinicalTrials.gov from conception to December 31, 2023, and manually extracted composition of race/ethnicity. We stratified trials by study characteristics, including impact factor, publication status, funding source, and location. We calculated the participation to prevalence ratio (PPR) by dividing the percentage of non-White participants by the percentage of non-White participants in the disease population (PPR of 0.8–1.2 suggests proportional representation) over time.

Results

We identified 277 completed AF trials encompassing a total of 1,933,441 adults, with a median proportion of non-White at 12% (interquartile range, 6%–27%), 121 (43.7%) device focused, and 184 (66.4%) funded by industry. Only 36.1% of trials reported comprehensive race information. Overall, non-White participants were underrepresented (PPR = 0.511; P < .001), including Black (PPR = 0.263) and Hispanic (PPR = 0.337) participants. The proportion of non-White participants did not change significantly between 2000 and 2023 (11% vs 9%; P = .343).

Conclusion

Despite greater awareness, race/ethnicity reporting and representation of non-White groups in AF clinical trials are poor and have not improved significantly over time. These findings demand additional recruitment efforts and novel recruitment policies to ensure adequate representation of these demographic subgroups in future AF clinical trials.