Key result
Applying FDA race categories to global HF trials reveals inconsistencies, classifying ~9% of Latin Americans as American Indian.
Why the study?
The applicability and understanding of US FDA-recommended standardized race and ethnicity categories in multinational clinical trials were uncertain.
Observational (n=54,087)
Yes
The application of US FDA standardized race and ethnicity categories in global clinical trials is challenging and often lacks relevance outside the United States.
Caution against unadapted FDA categories in global HF trials; challenges their validity and leaves standardization open.
BACKGROUND: The collection of race and ethnicity data in clinical trials using standardized categories is recommended by the US Food and Drug Administration, although this is primarily for domestic reasons. The applicability and understanding of the categories in multinational trials are uncertain. METHODS: We analyzed patient-level data from 13 major heart failure trials, examining race and ethnicity data recorded by country, as recommended by the Food and Drug Administration: "American Indian or Alaska Native," "Asian," "Black or African American," "Native Hawaiian or Other Pacific Islander," and "White" for race and "Hispanic or Latino" as a minimum for ethnicity (with an expanded list of ethnicities available). RESULTS: Of the 54 087 patients studied, approximately 32.3% were women. In the United States, 77% of patients were reported to be of White race and 19% of Black race with very few assigned to another race category (1% Asian, 0.7% Native American, 0.2% Native Hawaiian or other Pacific islander, and 1.4% "other"). In Europe, race was almost uniformly reported as White, and a similar racial homogeneity was reported in Asia (Asian race). Conversely, in Latin America, 8.9% of patients were described as "American Indian or Alaska Native," with a very high proportion in specific countries (eg, 36% in Guatemala and 21% in Mexico). In the United States, 6.2% of participants were reported to have Hispanic/Latino ethnicity but most patients in Latin America were reported to have this ethnicity; conversely, few patients had this ethnicity reported outside the Americas, including in Spain and Portugal. Among patients designated as Asian race, specific ethnicities (eg, Indian, Japanese etc) almost completely overlapped with the country of origin. CONCLUSIONS: This study highlights the challenges of applying standardized race and, particularly, ethnicity categories in global clinical trials. A multistakeholder approach is needed to improve the collection of race and ethnicity data in clinical trials.
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Yang et al. (2025) conducted an observational in Heart failure (n=54,087). Applying FDA race and ethnicity categories to 54,087 patients in 13 global heart failure trials revealed regional inconsistencies, with 8.9% of Latin American patients classified as American Indian.
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