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• W4387077298 abstract "Abstract Objective Describe the demographic profile of US participants in Amgen clinical trials over a 10-year period and variations across therapeutic areas, indications, and geographies. Methods Cross-sectional retrospective study including participants enrolled (2005–2020) in phase 1–3 trials completed between January 1, 2012 and June 30, 2021. Results Among 31,619 participants enrolled across 258 trials, one-fifth represented racial minority populations (Asian, 3%; Black or African American, 17%; American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, multiracial, each < 1%); fewer than one-fifth (16%) represented an ethnic minority population (Hispanic or Latino). Compared with census data, representation of racial and ethnic groups varied across US states. Across most therapeutic areas (bone, cardiovascular, hematology/oncology, inflammation, metabolic disorders, neuroscience) except nephrology, participants were predominantly White (72–81%). A similar proportion of males and females were enrolled between 2005 and 2016; male representation was disproportionately higher than female between 2016 and 2020. Across most medical indications, the majority of participants were 18–65 years of age. Conclusions and Relevance While the clinical research community is striving to achieve diversity and proportional representation across clinical trials, certain populations remain underrepresented. Our data provide a baseline assessment of the diversity and representation of US participants in Amgen-sponsored clinical trials and add to a growing body of evidence on the importance of diversity in clinical research. These data provide a foundation for strategies aimed at supporting more equitable and representative research, and a baseline from which to assess the impact of future strategies to advance health equity." @default.
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• W4387077298 date "2023-09-27" @default.
• W4387077298 modified "2023-10-16" @default.
• W4387077298 title "Diversity and Representation Among United States Participants in Amgen Clinical Trials" @default.
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• W4387077298 doi "https://doi.org/10.1007/s40615-023-01768-2" @default.
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