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Equity, diversity, and inclusion in pivotal medical device clinical investigations: a scoping review of studies published in the past 5 years
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DOI：10.1016/j.jclinepi.2026.112375.png)
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Abstract
En 中文
• Equity, diversity, and inclusion were rarely embedded in pivotal device trials. • Race and ethnicity were reported in only 35% of pivotal trials. • Population benchmarking of trial samples was absent. • Strengthening equity integration may improve external validity.
Keywords:
Equity
diversity
inclusion
medical device
pivotal clinical trials
external validity
representativeness
inequalities
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