The Immune Deficiency Foundation submitted comments to the U.S. Food and Drug Administration (FDA) in response to the FDA's draft guidance document, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” To ensure rare disease treatments have been adequately tested in the demographic groups that will ultimately use them, FDA must encourage sponsors of new medical products to:
- Collaborate with patient organizations when crafting clinical trial enrollment goals.
- Include participants who are immunocompromised in relevant studies.
