Why racial diversity in clinical trials is so important
Many factors can influence how individuals react to certain drugs, medical devices, and treatment plans. Age, biological sex, disabilities, chronic comorbidities, geographical location, gender identity, race, and ethnic background are all important components of medical decision making.
People of color, however, have been (and continue to be) particularly underrepresented in clinical research. It’s critical that the makeup of clinical trials reflects real-world populations, so that medications are tested for all who may need them. Here’s why racial diversity in clinical trials is imperative for the discovery and development of future medical interventions.
The need for diverse voices
Statistics from a panel discussion at the BIO Conference in 2019 revealed that racial and ethnic minorities make up 39% of the population in the U.S., but estimated rates of clinical trial participation for this group range from 2% to 16%. Nearly 14% of Americans are black, but they make up less than 5% of trial participants, and while Latinos make up 18% of the U.S. population, they represent just 1% of clinical trial participants.
As medicine becomes more sophisticated, with precision medicine, targeted drugs, and gene therapies coming to the fore, this lack of diversity in clinical trials can make it particularly challenging to get a complete picture of a drug’s safety and efficacy.
“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.”
Finding a solution to the diversity issue in clinical trials is crucial. But how did we get to this point in the first place?
Why are certain populations being left out of the picture?
Lack of insurance for many people in this country can be correlated with the lack of involvement with the healthcare system generally. Specialty care is often inaccessible and can be expensive, further limiting who can and cannot afford care — and therefore who is exposed to clinical trial opportunities. Difficulty finding transportation to reach clinical trial sites, overly stringent inclusion and exclusion criteria, language barriers, and distrust toward medical research also all contribute to the lack of diversity in clinical trials today.
This distrust of medical research deserves further exploration. Communities of color in America have historically had a fraught relationship with doctors. This can be traced all the way back to the slave trade, but one particularly well-known event is emblematic of why people of color often mistrust medical professionals — and why many are hesitant to participate in research, even today.
The Tuskegee Syphilis Experiment was run by the US Public Health Service between 1932 and 1972. The study recruited 600 black men, of which 399 were diagnosed with syphilis and 201 were part of a control group who did not have the disease. The researchers never obtained informed consent from the men and never told the ones with syphilis that they were not being treated. In reality, they were being observed, not treated. Then, their bodies were examined to allow scientists to document the ravages of the disease.
Because the study design was observational, that meant there was no intervention ever planned, despite the men undergoing various medical tests and being told that they were being treated for “bad blood.” Even following the discovery of penicillin thirteen years into the study, officials deliberately kept medication from those infected and continued to watch the effects of the disease for another 25 years. Throughout this time period, more than 200 of these men died and hundreds more, including their wives and the children that were born to them, were permanently injured.
The Tuskegee Syphilis Experiment is not the sole reason people of color mistrust doctors, but events such as these have planted doubt in these communities for generations, and led to discussion by many medical ethicists of what proper patient protections should look like.
How do we move forward?
The pharmaceutical and research industries must continue their efforts to drive and encourage minority participation in clinical trials.
In an episode of our Delivering on Diversity series, our Head of Partnerships, Lindsey Wahlstrom-Edwards, spoke with Allison Kalloo, Founder of Clinical Ambassador and the i-Participate initiative. Kalloo points out what the industry must do as a whole:
“Industry has to pledge allegiance to a more robust method of ensuring that their protocols are not unnecessarily restrictive or unrealistic, that their marketing is not stale or vague, that their recruitment budgets aren’t stingy, and that patient compensation isn’t patronizing.
Industry must also stop getting in their own way by using the big T words – Tuskegee and trust – as crutches or as excuses not to invest much time or energy in minority recruitment. When industry players talk amongst themselves and discuss the issue of diversity in their clinical sites, in their corporate boardrooms, and in their professional meetings, there should be balance.”
The FDA recently issued guidelines on enhancing the diversity of clinical trial populations, specifically focusing on eligibility criteria, enrollment practices, and trial designs guidance for industry. Major themes include:
- Making eligibility criteria less restrictive
- Ensuring trial participation is less burdensome for patients (reducing the frequency of study visits, using digital health technology tools, working with mobile medical professionals, and offering compensation for costs associated with participation)
- Enrolling participants who reflect the characteristics of clinically relevant populations with regard to age, sex, race, and ethnicity
- Including racial and ethnic minorities in clinical trials and the analysis of clinical trial data by race and ethnicity
- Providing resources in multiple languages
Sponsors and CROs should connect with patient advocates early in the drug development process, too. Advocacy groups (and individual advocates) can help shape and set the research agenda and open up dialogue around where needs are not being met in terms of current treatment options. With a deep understanding of the patient communities, they can also be key players in helping develop new methods of engaging participants in research.
The issue of diversity and clinical trial participation is critically important. Better treatments and potential cures will continue to be elusive for some segments of the population if trial populations don’t reflect the real world.