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BIO Comments on FDA Guidance on Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials

June 12, 2022

On Monday, June 13th, BIO submitted comments in response to a recently published FDA draft guidance providing recommendations to sponsors on developing a Race and Ethnicity Diversity Plan to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States. In addition to a number of specific line edits, BIO highlighted several, key areas where the Guidance could be improved. First, with reference to the critical role community engagement plays in enrolling underrepresented populations, BIO urged FDA to take steps to ensure the Agency has the expertise necessary to address concerns related to enrolling and retaining diverse patients. Secondly, BIO advised FDA to work with sponsors to ensure that FDA-sponsor communications are streamlined and consistently implemented across the Agency, building from provisions described in the PDUFA VII Commitment Letter. For example, providing further clarity on the timing and operational considerations for the FDA’s initial and subsequent review of sponsors’ diversity plans would help to ensure robust and productive communications. Given the emphasis on socio-cultural issues contributing to underrepresentation of certain racial and ethnic groups also BIO noted the importance of collecting and analyzing data by “self-assigned” or “self-reported” race and ethnicity. Finally, given clinical development programs are often conducted globally, BIO suggested that the Agency provide additional detail on how sponsors should incorporate this guidance along with existing international guidelines.

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BIO Comment on Diversity Plans to Improve Enrollment FDA 2021 D 0789
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