| アブストラクト | 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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| ジャーナル名 | Journal of the American Heart Association |
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| Pubmed追加日 | 2025/6/11 |
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| 投稿者 | Yang, Mingming; Kondo, Toru; Dewan, Pooja; Desai, Akshay S; Sibulo, Antonio S Jr; Lam, Carolyn S P; Chiang, Chern-En; Gomez, Efrain A; Martinez, Felipe A; Thierer, Jorge; Nicolau, Jose C; Kerr Saraiva, Jose F; Kitakaze, Masafumi; Packer, Milton; Vaduganathan, Muthiah; Vinh, Pham Nguyen; Abraham, William T; Jhund, Pardeep S; Solomon, Scott D; McMurray, John J V |
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| 組織名 | Department of Cardiology, Zhongda Hospital, School of Medicine Southeast;University Nanjing China.;British Heart Foundation Cardiovascular Research Centre University of Glasgow;Glasgow UK.;Department of Cardiology Nagoya University Graduate School of Medicine Nagoya;Japan.;Cardiovascular Division Brigham and Women's Hospital, and Harvard Medical School;Boston MA USA.;St. Luke's Medical Centre Quezon City Philippines.;National Heart Centre Singapore & Duke-National University of Singapore Singapore;Singapore.;Heart Failure Center, and General Clinical Research Center, Taipei Veterans;General Hospital National Yang Ming Chiao Tung University Taipei Taiwan.;Clinica Shaio Bogota Colombia.;Universidad Nacional de Cordoba Cordoba Argentina.;Centro de Education Medica e Investigaciones Clinicas Norberto Quirno Buenos;Aires Argentina.;Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de;Medicina Universidade de Sao Paulo Sao Paulo Brazil.;Cardiovascular Division Instituto de Pesquisa Clinica de Campinas Campinas;Brazil.;Kinshukai Hanwa Daini Senboku Hospital Osaka Japan.;Baylor Heart and Vascular Institute Baylor University Medical Center Dallas TX;USA.;Cardiovascular Center, Tam Anh hospital Tan Tao University Ho Chi Minh City;Vietnam.;Division of Cardiovascular Medicine The Ohio State University Columbus OH USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40497494/ |
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