A study by researchers at the University of California, Riverside and UC Irvine reviewed 341 pivotal trials conducted from 2017 to 2023. The authors found that only a small share of the trials reflect the United States racial and ethnic makeup, with Black and Hispanic people increasingly underrepresented after 2021. Asian representation rose during the period, while white participation remained largely stable.
The researchers explain that many pivotal trials follow International Council for Harmonisation (ICH) standards and are run across a few regions such as the US, Europe, China and Japan, which concentrates evidence in those places. Sub-Saharan Africa and much of Latin America host very few pivotal trials and are often left out of the data that shapes medicines for Americans.
The paper, published in Communications Medicine, recommends more diversity earlier in drug development, including setting diversity goals, choosing testing locations to reflect local health needs and collecting biological samples to study drug responses.
Difficult words
- pivotal — very important for the result or decision
- underrepresent — to show fewer people than existunderrepresented
- representation — presence of people from different groups
- harmonisation — making rules or standards the same
- diversity — variety of different people or elements
- collect — to bring together items or informationcollecting
Tip: hover, focus or tap highlighted words in the article to see quick definitions while you read or listen.
Discussion questions
- Why is it important for clinical trials to reflect the United States racial and ethnic makeup?
- What problems might happen if Sub-Saharan Africa and much of Latin America are left out of pivotal trials?
- What steps could researchers take to increase diversity earlier in drug development?
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