Diverse populations underrepresented in AF clinical trials
African American and Hispanic populations were often underrepresented in clinical trials of treatments for atrial fibrillation, according to a research letter published in JACC: Clinical Electrophysiology.
“This study adds to the growing body of literature that shows that minorities are underrepresented in our evidence base,” Fatima Rodriguez, MD, MPH, assistant professor of cardiovascular medicine at Stanford University, told Healio. “It is critical that the studies that inform practice guidelines represent the diverse populations we care for. The only way to track this important metric is to ensure that clinical trials have a standardized reporting of race/ethnicity (disaggregated to subgroups when possible).”
Trials included in guidelines
Ashish Sarraju, MD, cardiology fellow at Stanford University, and colleagues analyzed data from 34 trials that were cited in the 2019 American Heart Association/American College of Cardiology/Heart Rhythm Society focused update of 2014 guidelines for AF. These trials were conducted between 1996 and 2019 and addressed topics including procedural interventions, anticoagulation and antiarrhythmic drug therapies.
“Atrial fibrillation is a common condition in the United States,” Sarraju told Healio. “Clinical trials represent the cornerstone of our evidence base and are used to formulate major guideline practice documents and guide clinical practice. This, studying the reporting and representation of minority populations in trials is crucial in order to determine whether trial findings and related practice guidelines are generalizable to the diverse populations we care for across the United States.”
Researchers assessed the reported proportion of African American, non-Hispanic white, Asian and Hispanic participants. Overall percentages of participants were determined by pooling participant-level data. Information on reported geographic areas determined these percentages for studies without participant-level data.
Of the included studies, 44% reported participant-level racial/ethnic data. Eight trials reported information on geographical areas in the absence of participant-level data.
In addition, 14 trials reported participation rates for non-Hispanic white participants, eight trials reported on African American participants, seven trials reported on Asian participants and six trials reported on Hispanic participants. Disaggregated subgroup data on Hispanic or Asian participants were not available in any of the studies, and one trial reported on a combination of Arab and European participants.
Non-Hispanic white participants accounted for 85.6% of the population in trials that reported race/ethnicity. Trials that reported participant-level data on African Americans had a pooled African American participation of 2%.
Hispanic participation in trials that reported Hispanic data was 5.6%, whereas Asian participation in trials that reported Asian data was 10.3%.
Hispanic and African American populations were underrepresented in clinical trials when participation rates were compared with U.S. census data from 2010 and 2018.
Standardized reporting
“It may be helpful to standardize the reporting of racial/ethnic minority participation for uniformity including trying to report disaggregated subgroup data such as disaggregated Hispanic and/or Asian subgroups,” Sarraju said in an interview.
For more information:
Fatima Rodriguez, MD, MPH, can be reached at frodrigu@stanford.edu.
Ashish Sarraju, MD, can be reached at asarraju@stanford.edu; Twitter: @ashishsarraju.
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