The draft guidance from the US Food and Drug Administration released on 13 April, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry," seeks to increase the number of racial and ethnic participants that have historically been underrepresented in clinical trials.
FDA Draft Guidance Takes Aim At Racial, Ethnic Disparities In Clinical Trials
The US agency has outlined steps industry can take to ensure clinical trials include a broader representation of underrepresented racial and ethnic groups.
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