Placeholder Banner

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On Monday, June 13th, BIO submitted comments in response to a recently published FDA draft guidance providing recommendations to sponsors on developing a Race and Ethnicity Diversity Plan to enroll adequate numbers of participants in clinical trials from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.

Download Full Comments Below
BIO Comment on Diversity Plans to Improve Enrollment FDA 2021 D 0789
Discover More
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on…
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how…
On November 1st, BIO submitted comments in response to the Food & Drug Administration’s (FDA) recent Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. The meeting was primarily focused on two topics: the future of the…