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1
Demographic disparities persist in oncology clinical trials, affecting the generalizability of FDA drug approvals.
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2
Women, Black individuals, Hispanic populations, and older adults are significantly underrepresented in pivotal oncology trials.
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3
Enrollment incidence ratios revealed underrepresentation: females (EIR 0.83), Black individuals (EIR 0.26), and Hispanic individuals (EIR 0.50).
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4
Trial characteristics linked to underrepresentation include industry sponsorship and the use of overall survival as a primary endpoint.
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5
COVID-19 did not significantly alter representation trends, but older adults and White individuals showed diminished participation.