How FDA Is Helping Advance Clinical Trial Diversity

By RADM Richardae Araojo and Jovonni Spinner, Office of Minority Health and Health Equity, U.S. Food and Drug Administration

Ensuring appropriate representation of racial and ethnic minority groups in clinical trials for regulated medical products has long been a priority of the FDA Office of Minority Health and Health Equity (OMHHE).  Established in 2010, the FDA OMHHE is the first office at FDA dedicated to protecting and promoting the health of diverse populations through research, outreach, and communication that works toward addressing health disparities, health equity, and ultimately strengthening FDA’s ability to respond to minority health concerns.  OMHHE’s vision is to create a world where health equity is a reality.  Key to achieving that vision is increasing representation of racial and ethnic minority groups in clinical trials.

Clinical trials are critical to get new medical products to the marketplace. Data continues to show that racial and ethnic minority participation in clinical trials remains low. Even with decades of efforts to advance the representation of minority groups in clinical trials, we still have work to do.  Barriers to participation are many, including lack of trust due to historical abuses, language and cultural differences, religion, trial design, time away from jobs and other commitments, lack of awareness and knowledge about what a clinical trial is and what it means to participate, and lack of awareness of the physician/provider.  

But most importantly, the biggest barrier is often simply not asking the patient if they would consider participating in a clinical trial. This is where patient and provider communications become imperative. Frontline healthcare practitioners like nurses, pharmacists, physicians, physician assistants, and others on the healthcare team can play an active role in recruiting patients to join clinical trials.

Because clinical trials provide evidence for evaluating whether a medical product is safe and effective, ensuring appropriate and meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to advancing minority health. Representation matters because racial and ethnic minority populations are disproportionately burdened by many chronic and debilitating diseases but remain underrepresented in clinical trials. This means that there may be insufficient data to determine if minority populations respond differently to a medical product, further perpetuating health disparities.

FDA’s Diversity Initiative Promotes Trial Participation

In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA), specifically section 907, emphasized the need for increased racial and ethnic minority participation in clinical trials.  In response to FDASIA, OMHHE created the Diversity in Clinical Trials Initiative to raise awareness around racial and ethnic minority participation in clinical trials.  This initiative consists of an ongoing multimedia campaign to raise awareness about the importance of diverse participation in clinical trials and includes multiple strategies that highlight the value, risks, and benefits of clinical trial participation. We have developed a portfolio of educational resources and strategies that are culturally and linguistically tailored for our audiences, including:

• Educational materials like brochures, fact sheets, and post cards, in multiple languages
• Videos and public service announcements featuring diverse spokespersons sharing their unique perspectives on clinical trials
• Social media outreach encouraging different groups to participate in clinical trials, including tailored graphics that are representative of our communities
• Outreach to engage different communities and health professionals to raise awareness about the need for diverse participation in clinical trials
• Webinars, lectures, and podcasts
• Webpage with all resources and materials, including a communications toolkit

OMHHE’s Diversity in Clinical Trials Initiative continues to evolve as new resources and tools are added to advance the goals of the initiative. For example, last year OMHHE added two new public service announcements as part of this initiative featuring veterans sharing their stories to promote clinical trial participation. These veterans also participated in a podcast to share their unique stories and provide deeper context as to why clinical trial diversity matters. Many more resources are in the pipeline and slated to be released this year and beyond.

Central to our clinical trial diversity efforts is establishing and building sustainable relationships with our stakeholders. Their input is important to help guide our work. We have established a solid foundation across FDA with our public- and private-sector stakeholders from academia, nonprofit organizations, regulated industry, and patients, among others, to achieve our mission.  It is critical that our stakeholders represent the diversity of the U.S. population, including individuals of low socioeconomic status and historically underrepresented populations that experience significant health disparities — disparities that span a multitude of dimensions, from differences among racial and ethnic groups, geography, gender, age, or disability, for example. 

OMHHE staff regularly engage with our stakeholders by presenting and exhibiting at several health conferences and events, both health professional and consumer focused, across the country. We also host public meetings to provide stakeholders with an opportunity to learn more about our key priority areas and to strategize on ways to improve our research and communications programs. Only by engaging with diverse stakeholders and developing partnerships and collaborations can we meet the needs of the communities we serve and strengthen FDA’s ability to respond and ultimately help provide everyone the best chance to attain their highest level of health. 

We continuously work to answer pressing health disparity, health equity, and regulatory science research questions, to increase data available on racial and ethnic minority populations, and to promote health and safety communication to minority and underserved populations who often experience low literacy or speak English as a second language.  By continuing to expand our repository of culturally and linguistically tailored health education materials, we can help patients to better understand clinical trials and feel comfortable starting the conversation with their medical provider. All of our materials can be found on our website at www.fda.gov/healthequity. Increasing minority participation will take a multifaceted, all-hands-on-deck approach to ensure that both patients and providers are educated and help move the needle forward.

About The Authors:

Rear Admiral Richardae Araojo, PharmD, MS, serves as the associate commissioner for minority health and director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA). In this role, she provides leadership, oversight, and direction on minority health, health disparity, and health equity matters for the agency. RADM Araojo received her doctor of pharmacy degree from Virginia Commonwealth University, completed a pharmacy practice residency at University of Maryland, and earned a master’s degree in pharmacy regulation and policy from the University of Florida.

Jovonni Spinner, MPH, CHES, is an award-winning public health strategist and thought leader with a deep passion for improving health equity across the lifespan through research, communication, multi-sector partnerships, and leadership coaching. She is a senior public health advisor at the FDA’s Office of Minority Health and Health Equity, overseeing the strategic direction of the outreach and communications team and leading the Diversity in Clinical Trials Initiative. She is an alum of Virginia Commonwealth University and Emory University and is pursuing her doctorate from Morgan State University.