DOI: 10.1161/circ.148.suppl_1.17493 ISSN: 0009-7322

Abstract 17493: Racial/Ethnic Under-Representation in Early Phase Clinical Trials

Halima White, Muhammed Idris, Anekwe Onwuanyi, Latha Palaniappan, Eldrin F Lewis, Priscilla Pemu, Kira Clark, Victor Ritter, Sa Shen, FeiFei Qin, Joseph-Kelvin Igwe, Erin R Cruz, Cati Brown Johnson, Jo Ann Cross, Marcia L Stefanick, Paul J Wang
  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Introduction: There is severe underrepresentation of racial and ethnic groups in many cardiovascular clinical trials. Early-phase clinical trials examine the action and safety limits of treatment and thus, underrepresentation may have particularly deleterious effects.

Hypothesis: Ethnic and Racial groups are underrepresented in early-phase trials.

Methods: Using the database, we examined the racial and ethnic representation in Phases 1, 2, 3, and 4 in completed heart failure clinical trials (N=89) with reported results from 2016-2021. We examined the proportion of trials with a representation equal or greater than % U.S. Census population (12% for African American (AA), 19% for Hispanic/Latino (HL), and 7% for Asian (AN)) and determined the median trial representation percentage for AA, HL, and AN groups. Using Chi-square analysis we compared the percent representation across the trial phases.

Results: We found that 49%, 91%, and 87% Phase 1 and 2 trials have a lower AA, HL, and AN representation, respectively, compared to that in the U.S. Population (Table 1). HL and AN representation in Phase 1 and 2 trials is particularly low. There is significant variation in AA, HL, and AN representation across all trial phases(p<0.001).

Conclusions: Significant underrepresentation of racial and ethnic groups persist in contemporary Phase 1 and 2 trials. Efforts to create a standard for collecting and reporting demographics along with increasing racial and ethnic group representation closer to US population may reduce the risk of future adverse events.

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