BlackDoctor.org: What initiatives of the FDA have been most effective in reaching minority groups and reducing health disparities? How do you measure success?
Dr. Bull: One way the FDA has been effective in reaching minorities is through our “Diversity in Clinical Trials Initiative”. We are committed to encouraging participation of diverse patient populations in biomedical research used to support marketing applications for FDA-regulated products, like new HIV medications. Over the past two decades, the FDA has taken a multitude of steps to enhance representation of diverse populations in clinical trials through various initiatives and outreach strategies, including:
Last year, we launched our Diversity in Clinical Trials campaign where we featured an African American woman telling her story about participating in clinical trials and helping to dispel myths. This campaign included 6 videos, brochure, fact sheet, and other collateral materials, plus extensive social media outreach to help raise awareness.
We have encouraged participation of racial and ethnic groups in all phases of medical product development and believe that potential differences in responses to medical products in subgroups are important to the FDA’s efforts to ensure safety and efficacy is studied in those who will use these products once they are approved.
We recommend that risk/benefit be assessed for all affected demographic subgroups, including for example, geriatric patients who are far more likely to have multiple illnesses, receive multiple drugs and other treatments and often have co-morbidities that could interact with investigational drugs.
BlackDoctor.org: In African American communities, misinformation about or distrust of clinical trials are still prevalent. Tell us about the importance of clinical trials and how they work.
Dr. Bull: Historically, minorities have been under-represented in clinical trials. Inclusion of clinically meaningful subpopulations in clinical trials helps to properly evaluate the safety and efficacy of medical products.
When clinical trial participants reflect a diverse sample of the general population, and when the sub-population data are appropriately analyzed, much more information will be known about medical products and more meaningful clinical data can be communicated to the public. In summary, medical products are safer and more effective for everyone when clinical research includes diverse populations.