Making Research Fair and Equitable

By: Samah Shah, Research Associate and Buck Racial Justice Task Force Member

Since the 20^th century, science has made great leaps in increasing the life expectancy of Americans. Many Americans are living longer and healthier lives, benefiting from the decades of longevity research done by scientists like those here at the Buck Institute. Between 1950 and 2013, life expectancy at birth has increased by over 10 years. However, when we dig deeper into these numbers, it is clear that these strides were not evenly made across racial and ethnic subgroups. Science has made incredible achievements in this field, and while it is important to celebrate that, it is crucial to address the fact that millions of people are not experiencing the benefits of these scientific achievements.

While 56.7% of white non-Hispanic Americans live to the age of 80, only 48.3% of African Americans do. Many people try to explain this by claiming it is due to behavioral differences between these two racial groups but this has been proven to not be the case. White Americans live longer than African Americans, yet Whites have higher rates of smoking, heart disease and lung cancer. The issue here, as is often the case, is the structural disadvantages that African Americans face in the US which both create and exacerbate the health risks the Black community experiences. These structural disadvantages include but are not limited to: limited access to healthy food, safe environments, good education and livable wages. These factors reinforce each other and produce poor health outcomes among members of the Black community. Not only does this result in a shorter lifespan, but the quicker decline in physical abilities creates financial problems and caregiver burdens which reinforces the systemic disadvantages for the next generation. This concept of systemic stressors speeding up the aging process is known as biological weathering.  

Historically this has been viewed as a social justice issue for policymakers and activists to take care of while the rest of us ‘focus on the science’, but this is clearly an issue that people in every position can and should address. There are steps researchers at every level can take to try to reduce these dramatic differences – or at the least, refrain from adding to the problem.

If we look at the current state of clinical trials in the US, it is embarrassingly clear that the demographics of these trials do not match the demographics of the patients suffering from the disease of interest. A Nature editorial showed the demographics for 31 cancer drugs approved by the FDA since 2015. The article showed that while African Americans made up 13.4% of the US population, this community accounted for less than 5% of clinical trial patients for 24 of the 31 drugs. These numbers hold up to scrutiny - African Americans make up 14% of people diagnosed with multiple myelomas, yet they made up 5% of participants in clinical trials for four multiple myeloma drugs. Further, the Hispanic community accounts for 16% of the US population, but only 1% of clinical trial participants.

This problem has only grown in significance amidst the current pandemic. The clinical trial populations for the Pfizer-BioNTech and Moderna COVID-19 vaccines were comprised of 81.9% and 79.4% white Americans respectively This fact is even more distressing when you consider the fact that “the percent of Hispanic or Latino, non-Hispanic Black and non-Hispanic American Indian people who have died from COVID-19 is higher than the percent that these racial and ethnic groups among the total U.S. population. This disparity is even greater when the percentages are age-standardized, according to an article by the CDC. In order to effectively increase diversity in clinical trials, many resources have been published online with reasonable strategies for addressing this problem, specifically with respect to Black and African American communities.

A key strategy is for investigators and clinical trial directors to make a conscious effort to overcome the historical distrust that African Americans have with the medical establishment. For example, while African Americans are underrepresented in clinical trials, they are overrepresented in the “exception from informed consent” (EFIC) pathway for clinical trials that are performed on incapacitated patients. A review paper from 2018 stated “among the 46,963 patients included ninety-six percent were enrolled without consent … Nearly one-third of the US patients in EFIC trials were African American.”  The most infamous example of uninformed consent is the Tuskegee Syphilis Study – an ethically abusive study conducted by the United States Public Health Service and the CDC in which African-American men were explicitly told they were receiving syphilis treatment when instead the US government was actively withholding treatment. It is important to note that this study was only terminated in 1972, less than 50 years ago, and the New York Times has estimated that as many as 107 Black men died as a direct result of their untreated syphilis. The responsibility is on investigators to work with historically neglected communities to repair some of this damage and move forward with straightforward communication and transparency.

More strategies to increase diversity in clinical trials include educating physicians and clinical trial directors on the race/ethnicity-based differences in disease prevalence, and bringing more doctors of racial and ethnic minorities into these trials – as studies have shown that minority patients tend to seek out physicians of the same race. Reaching out to trusted leaders in the community and seeking their support is referred to as community-based participatory research (CBPR) and has also been proven to be an effective approach.

Finally, putting more thought into the logistics of when and where clinical trials are held is a helpful step in addressing lack of diversity. Clinics and hospitals located far away from where communities of color live is an obvious barrier to participation and even awareness for these underserved communities. (At the end of this article, there are some links to more in-depth articles that specifically outline these strategies and more.)

The advice is not only applicable to clinical trial research but rather to all health-related research. Many of the chronic diseases disproportionately affecting racial and ethnic minorities are studied right here at the Buck. It is incumbent on all of us to ask each other some questions to engage with historically neglected communities. Among these questions: Who is donating your tissue samples? How many racial and ethnic minorities, particularly Black and African American investigators, are included in your grants and conferences? Do you understand the mistrust of the Black community towards the medical establishment? Addressing these issues will ultimately help provide better and more equitable healthcare where it is actually needed the most.

Further reading for increasing diversity in research:

• Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials
• Diversifying Clinical Trials
• Recruitment of Underrepresented Study Populations (webcast + Q&A)
• Increasing and Sustaining Racial/Ethnic Diversity in Healthcare Leadership