Minorities and Clinical Trials: Why it Matters

Clinical trials are “voluntary human research studies designed to answer specific questions about the safety and effectiveness of medical products, which include drugs/medications, vaccines, devices, diagnostic tests, and other therapies, or to study new ways of using existing treatments” [1]. Before the Food and Drug Administration (FDA) can approve new medical products, experimental medications and therapies are tested in controlled environments on the people most likely to use them. This process enables FDA and medical product developers to ensure that medical products are safe and that they work for their intended uses.
Clinical trials are critical to developing better treatments for diseases affecting minorities, like diabetes, kidney disease, and cardiovascular disease.  It is known that minorities can respond differently to medical products (e.g., drugs, biologics, devices) [2-3] so representation matters as we aim to close the disparity gap on diseases disproportionately impacting minorities.

Historically, racial and ethnic minorities (referred to here as minorities) are underrepresented in clinical trials [4-8]. This is unfortunate because kidney disease disproportionately impacts African Americans and Hispanics. For example, 35% of African Americans suffer from kidney failure and Hispanics have experienced a 70% increase in kidney failure cases since 2000 [9]. 

Many barriers have been documented as to why minorities do not participate in clinical trials, such as mistrust and distrust of the medical system, the perception that minorities are not eligible, or lack of monetary compensation, to name a few [1, 4-5]. Here in the Office of Minority Health and Health Equity, we are committed to creating a world where health equity is a reality for all. One of our flagship campaigns is the “Diversity in Clinical Trials,” which is an office priority area. We are raising awareness about the importance of having diverse people join a clinical trial. We are helping combat myths, by giving credible, culturally, and linguistically tailored materials so our consumers can make informed decisions about their health.

We have developed a multi-media health education campaign about the importance of minority representation in clinical trials, to ensure that medical products are safe and effective for everyone. A variety of tools and resources were developed such as short educational videos sharing people’s experiences participating in clinical trials and why it matters to them, webinars and lectures, podcasts, website, print and digital materials like brochures and fact sheets. We also have an active presence on social media, spreading positive reinforcing messages. Our materials are translated into other languages, like Spanish, to ensure our materials are accessible to everyone. We are committed to closing the health equity gap; reaching millions of consumers and serving as a credible source of information. Our team works tirelessly, adding, and developing new resources to our toolbox to meet our consumers' needs. We encourage you to visit our clinical trials webpage to learn more.

Jovonni Spinner was the featured speaker in AKF’s webinar, “Clinical Trials and Kidney Disease.” The webinar is available on-demand on AKF’s website.

References

  1. Food and Drug Administration. FDA Encourages More Participation, Diversity in Clinical Trials. January 2017.
  2. Burroughs VJ, Maxey RW, Levy RA. Racial and Ethnic Differences in Response to Medicines: Towards Individualized Pharmaceutical Treatment. J Natl Med Assoc. 2002;94(10):1-16.
  3. Yasuda SU, Zhang L, Huang SM. The Role of Ethnicity in Variability in Response to Drugs: Focus on Clinical Pharmacology Studies. Clinical Pharmacology and Therapeutics. 2008;84(3):417-423. 
  4. Tanner A, Kim S, Friedman DB, et al. Barriers to Medical Research Participation as Perceived by Clinical Trial Investigators: Communicating with Rural and African American Communities. J Health Commun. 2015;20(1):88-96.
  5. Fisher JA. Challenging Assumptions about Minority Participation in US Clinical Research. Am J Public Health. 2011;101(12):2217-2222.
  6. Geller SE, Koch A, Pellettieri B, et al. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress? J Womens Health. 2011;20[3]:315-20.
  7. Williams M, Powers M, Yun YG, et al. Minority participation in Randomized Controlled Trials for Obsessive-Compulsive Disorder. J Anxiety Disord.  2010;24(2):171-177.
  8. Evelyn B, Toigo E, Banks D, et al. Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999. J Natl Med Assoc. 2001; 93(12 Suppl):18S-24S.
  9. U.S. Renal Data System, USRDS 2016 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2016.

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About the Author(s)

Cariny Nunez and Jovonni Spinner

Jovonni R. Spinner, MPH, CHES is senior public health advisor at the U.S. Food and Drug Administration (FDA) and lead for the outreach and communications team in the Office of Minority Health & Health Equity (OMHHE).

Cariny Nuñez, MPH, CHRM, COR, is a senior public health advisor for the Office of Minority Health and Health Equity (OMHHE) within the Office of the Commissioner; she’s the co-lead for the Outreach and Communications Program within FDA OMHHE and the agency’s lead for the Language Access Program.

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