The Role of African American Physicians to Enroll African Americans in Clinical Trials
The National Black Church Initiative (NBCI), a coalition of 150,000 African-American and Latino churches with a population of 27.7 million, focuses on eradicating racial disparities in healthcare, clinical trials, technology, education, housing, and the environment. NBCI advocates for drug therapies to improve the overall health and well-being of African-Americans and Latinos.
Therapeutic Areas of Interest to the African-American and Latino Communities: NBCI Clinical Research Approach
There are eleven (11) pillars of NBCI Clinical Research Approaches to be used:
- Cardiovascular Diseases
- Cancer: (Liver/ Kidney/ Lung ...etc)
- Diabetes
- Blood Diseases
- Genetic Disease ( Sickle Cell)
- Mental health
- Access to Care/ lifestyles/ Selfcare
- Parkinson Disease
- Collection of Health Data
- Alzheimer's Disease
- Rare Diseases
- Others
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
This draft guidance describes the form, content, and manner of diversity action plans, the applicable medical products, and clinical studies for which a diversity action plan is required, the timing and process for submitting diversity action plans, and the criteria and process by which FDA will evaluate sponsors’ requests for waivers from the requirement to submit a Diversity Action Plan. It replaces the draft guidance for industry entitled “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials,” published April 14, 2022
FDA is issuing this guidance as mandated under section 3602 of FDORA, which requires that FDA update or issue guidance relating to the format and content of diversity action plans required by sections 505(z) and 520(g) of the FD&C Act (21 U.S.C. 355(z) and 360j(g) as amended by section 3601 of FDORA.