The U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This guidance is aimed at assisting medical product sponsors in submitting “Diversity Action Plans” for certain clinical studies.
These plans are designed to enhance the enrollment of historically underrepresented populations in clinical trials, thereby improving the quality and applicability of the data received by the FDA. By including a diverse range of participants, the FDA aims to ensure that clinical trial results better reflect the broader patient population that will ultimately use the medical products.
Read more at this link on the US FDA website.
