Recent Guidance on Diversity Action Planning

As the science behind regulatory approvals advances to incorporate smaller patient populations, novel study designs, surrogate endpoints, and real-world evidence, an important unmet need has become increasingly apparent: the need for drug approvals supported by generalizable data obtained through recruiting more diverse patient populations. 

This is the subject of the FDA’s recently released draft guidance “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” 

The guidance is a highly anticipated update to the Agency’s 2022 draft guidance “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials.” 

To learn more about the changes in this new guidance and their implications for the future of clinical development, please view our recent webinar.