Minority Health Month: Why Diversity is Necessary in Clinical Trials

April is National Minority Health Month in the United States. This is a time to highlight the importance of improving health for racial and ethnic minority communities and reducing health disparities in the United States. Racial and ethnic minority populations are underrepresented in clinical trials. According to the Food & Drug Administration (FDA), in 2020 75% of trial participants were white, 11% were Hispanic, 8% were Black, and 6% were Asian. Nearly 40 percent of people in the United States belong to a racial or ethnic minority. These data show that clinical trial participation is not representative of the United States population overall. Research professionals must work to increase participation and ensure that minority communities are asked to participate in research. 

About Diversity

Diversity in research is the representation and inclusion of people with a variety of characteristics, including race, ethnicity, age, gender, sexual orientation, income, disability status, education level, geographic location, and more. Research staff must be intentional to reach and recruit diverse participants to studies. 

There are many reasons why racial and ethnic minorities participate in research less frequently than white populations. One reason is past medical and research abuses and ethical issues that have led to mistrust in research and health care and reluctance to participate. Some populations also report fear of discrimination as a reason not to participate. While regulations and laws are in place to prevent abuses and discrimination today, mistrust understandably remains. Another significant reason racial and ethnic minorities participate in research less frequently is simply not being asked to participate. The majority of clinical trial participants enroll when asked by their provider, yet not everyone is asked. Eligibility criteria is another barrier. For example, clinical trials may exclude people with certain health conditions like diabetes, high blood pressure, and kidney disease. These diseases disproportionately affect racial and ethnic minorities and thus exclude these populations from participating in many studies. Other barriers include lack of access to academic or specialty health care centers that offer trials, time to participate, and financial resources.

So why is diversity important for research, and what steps can researchers take to increase diversity in their trials?

Study Generalizability and Applicability 

One reason that diversity is critical for clinical trials is to ensure that study results can be generalized as much as possible and applied across multiple populations. People experience diseases, such as cancer, differently, so a variety of experiences and data should be collected in research. This is especially important for clinical trials that study the safety and effectiveness of new treatments and drugs. Not all people react the same to medications and treatments. Treatments may not be as effective in some groups as others or may cause different side effects and symptoms. Studies should include participants from a variety of backgrounds to better understand the treatment and ensure it is safe and effective for everyone, not just the majority white population. 

Clinical Trial Benefits

Participating in clinical trials comes with potential benefits like accessing new treatments before they are widely available, reimbursement, control over one’s health, and more. Everyone should have equal access to these benefits, regardless of their race, ethnicity, or other backgrounds and characteristics. 

Health Equity & Ethics

Diversity is critical in research to ensure health care and outcomes are ethical and equitable. Research helps us better understand health disparities. The CDC defines health disparities as “preventable differences in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by socially disadvantaged populations.” An example of a health disparity is that Black women are more likely to die from breast cancer than white women despite having similar rates of diagnosis. By better understanding health disparities and determining why differences exist, researchers, health care professionals, and communities can work together to develop interventions, prevention strategies, policies, and more to close these gaps and work toward health equity. Health equity is the state in which everyone has a fair and just opportunity to attain their highest level of health. Research is just one component of health equity, and we must all work together to take steps toward health equity in research and beyond. 
 

Resources & Learn More

National Minority Health Month 

What Does Diversity Mean in Clinical Trials?- CITI Program

Clinical Trials Need More Diversity- Scientific American

Why Diversity Matters in Clinical Trials and Research- WebMD