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People of Color Face Disparities in Access to Clinical Trials, New Drugs, and New Therapies 

Data from the 2015-2019 FDA Drug Trials Snapshot showed that White people comprise over 70 percent of clinical trial participants even though almost 40 percent of the U.S. population is comprised of racial and ethnic minorities. Currently, Black people comprise less than five percent of all oncology clinical trial participants.1

According to a 2024 Kaiser Family Foundation study, people of color “face increased barriers to accessing new drug therapies and treatments due to lack of diversity in clinical trials and structural barriers, including financial barriers.”2

What Are Some Facets of Structural Racism and Financial Barriers?  

Factors such as being uninsured, having comorbidities, or being denied coverage for services rendered may prevent people of color from participating in clinical trials.3 Some treatments may not be covered by insurance, while others may still incur high out-of-pocket costs, even with insurance coverage.1

While patient discounts may be available, access to them be varied or limited.1

Also, studies identify “limited transportation options, inflexible work schedules, and lack of technology” as hindrances to clinical trial participation for people of color. In some cases, healthcare professionals may be less likely to discuss clinical trials with people of color4 

Understanding these barriers to clinical trials is the first step to increasing access.

Why Is It Important to Increase Access to Clinical Trials for All?  

Unfortunately, existing disparities in access to treatment for people of color worsen due to the lack of diversity in clinical trials. This lack of representation in clinical trials “can obscure the safety and efficacy of drug therapies and limits our collective ability to develop effective treatments for all patients, leading to even wider health disparities.”1 

An issue with these limitations to access to clinical trials is that over 80 percent of genomic data “driving the recent advances in personalized healthcare is derived from individuals of European ancestry, even though pharmacogenetic studies have demonstrated significant racial/ethnic differences in drug metabolism, safety, and other biomarkers.”Drugs, vaccines, and other therapies may affect patient groups “differentially due to variations in underlying experiences and environmental exposures.”4 

To better understand how cancers affect people of non-European ancestry, people of all ancestries must be included in the clinical trial process. Furthermore, racial and ethnic diversity in clinical trials is crucial “in building confidence in the effectiveness of new treatments.”4 

What Are Ways Healthcare Professionals Can Improve the Conversation Around Clinical Trial Enrollment and People of Color? 

According to a 2021 New England Journal of Medicine study, “engaging community clinicians in clinical research could have multiple benefits” and “may help increase diversity in clinical trials.”5 

By collaborating with community clinicians, challenges in accessibility and enrollment may also be addressed. Some clinicians collaborate with other organizations for research, thus enabling them to gather much-needed information from varied stakeholders.5 

Finally, the 2024 Kaiser Family Foundation Study discussed the following recommendations to prevent widening disparities in the future:6 

  • The Food and Drug Omnibus Reform Act enables the FDA to “require diversity action plans for certain clinical trials that specify enrollment goals to address historical underrepresentation of certain groups.” FDA recommendations on diversity action plans can be found in the April 2022 FDA industry draft guidance. 
  • By expanding coverage for new drugs, treatments, and therapies, financial access barriers may be alleviated. However, disparities in financial barriers may still persist. 
  • Equity in access to new treatments should be a priority amid the rise in use of clinical algorithms and artificial intelligence (AI) in healthcare. While the use of AI in healthcare is becoming the norm, ensuring that algorithms do not perpetuate disparities and biases is crucial. 
  • To “monitor and evaluate the use, safety, and effectiveness of AI,” the FDA has proposed a 2021 framework, “which includes a focus on improving methods to identify, evaluate, and address algorithmic bias.7 
  • The Department of Health and Human Services issued a proposed rule in 2022, “prohibiting discrimination through the use of decision-making clinical algorithms. However, researchers have noted that “the proposed rule does not offer specific guidelines on how to prevent discrimination and that there are a wide range of potential strategies available for reducing bias in clinical algorithms.”8 

  

 

 

Click to view footnotes
  1. Peters, U., Turner, B., Alvarez, D. et al. Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials. Ther Innov Regul Sci 57, 186–195 (2023). https://doi.org/10.1007/s43441-022-00464-3 
  2. Ndugga N. Pilla, S. “Racial and Ethnic Disparities to Medical Advancements and Technologies.” Kaiser Family Foundation, February 22, 2024. 
  3. Hamel, L.M., et al. “Barriers to Clinical Trial Enrollment and Ethnic Minority Patients October 1, 2016.  
  4. Green, A.K., et al. Despite the FDA’s Five-Year Plan, Black Patients Remain Inadequately Represented in Clinical Trials for Drugs. March 2022. Health Affairs, Vol. 41, No. 3. https://doi.org/10.1377/hlthaff.2021.01432 
  5. Woodcock, J., et al. Integrating Research into Community Practice-Toward Increased Diversity in Clinical Trials. October 7, 2021. N Engl J Med 2021; 385:1351-1353. DOI: 10.1056/NEJMp2107331 
  6. Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability. April 2022. U.S. Food and Drug Administration. Docket Number: FDA-2021-D-0789 
  7. Artificial Intelligence/Machine Learning [AI/ML]-Based Software as a Medical Device (SaMD) Action Plan. U.S. Food and Drug Administration, January 2021. 
  8. Fact Sheet: Nondiscrimination in Health Programs and Activities Proposed Rule Section 1557 of the Affordable Care Act. U.S. Department of Health and Human Services. 
The M-Power Project

The IMF’s M-Power Project partners with clinicians and communities to keep discussions like this one going and ultimately increase access to clinical trials, new drugs, and new therapies.

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