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BIO Comments on FDA Draft Guidance on Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs

August 6, 2019

BIO submitted comments on the Food and Drug Administration (FDA) Draft Guidance, Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.

BIO welcomes FDA’s recommendations to broaden eligibility criteria and increase enrollment of underrepresented populations in clinical trials. BIO believes improving diversity of clinical trial populations is an important issue and agrees with the Agency’s view that adopting more inclusive enrollment practices will open clinical trials to a diverse participant population reflective of the population that will use the drug.

While we understand the FDA’s goal of improving representativeness of clinical trial populations, we believe policy development on the topic requires a more comprehensive approach. BIO provides suggestions on how to increase patient representativeness as well as how to edit and clarify certain sections of the guidance, specifically around the meaning of “population diversity.”

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