Why racial diversity in clinical trials is so important
There are many things that may influence how an individual reacts to a certain drug, medical device, or treatment plan. This can include age, biological sex, disabilities, chronic comorbidities, geographical location, gender identity, race, and ethnic background, and more — all of which should be considered in the medical decision-making process.
Because of all these factors, it is vital that new medications are tested in clinical trials where participants are reflective of real-world populations. Unfortunately, because people of color have historically been underrepresented in research studies, medications are not always tested in ways that reflect the needs of diverse patient groups. But, by using smart clinical trial recruitment strategies, sponsors can ensure that they are developing medications that will work for all who need it.
The need for diversity in clinical trial participation
Statistics show that racial and ethnic minorities comprise 39% of the United States population but only account for 2% to 16% of clinical trial participants. While around 14% of Americans are black, they account for less than 5% of trial participants. Latinos, who make up 18% of the U.S. population, only represent 1% of clinical trial participants.
Pharmaceutical companies are developing more specific and sophisticated drugs, but without adequate diversity in clinical trials, it is impossible to get a clear picture of the drug’s safety and efficacy in various populations.
“When you don’t have inclusion of diverse communities, you run the risk of making assumptions about drug safety and effectiveness that may not be accurate,” said Stephanie Monroe, executive director of AfricanAmericansAgainst Alzheimer’s, in an interview at the Biotechnology Innovation Organization’s annual meeting in 2019. “Generalizing findings of the current majority of participants – white, European men – to African Americans, Latinos, women, and others may be embracing false assumptions about the lack of differentiation between what is fast becoming the new majority.”
Clearly, it is crucial to find a solution to the clinical trial diversity problem — but first, it is important to understand how the industry got to this point.
Why are minorities underrepresented in clinical trials?
Many people in the United States do not have access to health insurance and are thus not involved with the healthcare system for things that are not absolute necessities. Specialty care — a common way for people to learn about relevant clinical trial opportunities — is often cost-prohibitive and difficult to access. Additionally, challenges surrounding reliable transportation, navigating inclusion criteria, overcoming language barriers, and general distrust towards medical institutions can all contribute to a lack of diversity in today’s clinical trials.
Why is there a historic mistrust of medical institutions?
While there may be many personal factors that play into an individual’s mistrust of medical institutions, there is also a historic basis for this skepticism. The Tuskegee Syphilis Experiment, a study run by the US Public Health Service between 1932 and 1972, recruited 600 black men to participate — 399 of whom were diagnosed with syphilis, with 201 in a control group.
This study was designed to be observational, so no medical intervention or treatment was ever planned for the participants. However, the participants were not given informed consent, and were instead told they were being treated for “bad blood” when they were subjected to an array of tests administered by the researchers. In spite of penicillin being discovered as a syphilis treatment 13 years into the study, the researchers deliberately withheld it from the participants, allowing the infection to ravage the patients’ bodies without interruption.
Over the course of the study, over 200 participants died, while hundreds more were permanently injured — as were many of the participants’ wives and children. While this study is not the only reason for mistrust of medical institutions, events such as these have sown doubt in communities of color for generations.
How can medical researchers move towards diversity?
For the future of medicine to be equitable and accessible for all, the pharmaceutical and medical research industries must focus on patient centricity for diverse populations.
In an interview with Allison Kalloo, Founder of Clinical Ambassador and the i-Participate initiative, Kalloo points out the issues surrounding study design as a barrier to trial participation:
“For Black and Brown people who wrestle with social determinants of health, having comorbidities or pre-existing conditions summarily excludes these individuals from participation at the gate. Other prohibitive study factors can be the location, distance to trial sites, work and caregiving constraints, and sometimes a lack of access to technology, especially for decentralized trials and hybrids that require data input and monitoring. When you’re a person of color, there can be a swirling mix factoring into one’s access, perceptions, trust, and willingness to participate in clinical trials.”
The FDA’s recent guidelines detail how to enhance the diversity of clinical trial participants, focusing primarily on eligibility criteria, enrollment practices, and guidance for industries. The major themes include:
- Reducing restrictions for eligibility
- Making trial participation less cumbersome by requiring fewer site visits, utilizing health technology, working with mobile site professions, and/or offering compensation for costs incurred due to participation
- Enrolling participants who reflect real-world patient populations in regards to age, sex, race, and ethnicity
- Analyzing clinical trial data by race and ethnicity
- Supplying trial information in multiple languages
Connecting with patient advocates early in the study design process can be helpful for sponsors, too. These advocates can provide valuable insights into research agendas and how to meet patients' needs, including why current treatment options fall short and why patients might be motivated to participate in research. A deeper understanding of patient communities can allow trial sponsors to become major resources for patient engagement.
When trial populations don’t reflect the real world, it creates more roadblocks to finding better treatments and potential cures — this is why the issue of diversity in clinical trial participation is so important for all sponsors across all conditions.
