Clinical Trial Diversity at Risk: The Real-World Impact of Budget Cuts

With economic uncertainty and cuts to healthcare – both made and proposed – the impact is already being seen and felt in communities across the country. In my work, I worry about the impact the government cuts are likely to have on the ability to conduct clinical trials, particularly those that aim to address diversity. In fact, I am already seeing the trickle down effects from shifts in the economy, where access to housing and transportation has decreased and food insecurity has increased. Those who are losing – or at risk of losing – insurance coverage are becoming no-shows for their clinical trials visits, which, for some, is their only access to healthcare and treatment. 

When it comes to budget cuts, we anticipate reduced funding for initiatives aimed at recruiting diverse populations, which will result in less representation of minority and underrepresented groups in clinical trials. That representation is crucial for understanding how different populations respond to treatments. We already know that effective recruitment of diverse populations often requires targeted outreach and education efforts, so any action that reduces the amount of money and resources for that work will have a direct – and negative – impact on that work. 

In addition, budget constraints will impact: 

• The quality of data collected, which is essential for ensuring trial results are applicable to diverse populations.
• Partnerships with community organizations that are essential for reaching diverse populations (which often require financial support).

While I know those of us in healthcare would like to move on from all comparisons to COVID-19, the reality is the current situation can be compared to the pandemic – changes that are quick, unexpected, and leaving people scrambling to figure out what to do. 

Inclusive clinical trials are critical to a healthy America 

The goal of biomedical research is to improve the health and well-being of the entire population, which is made up of diverse individuals. Ensuring diversity in clinical trials leads to more robust and reliable data, which is essential for developing effective and safe medical interventions for everyone and helps further our understanding of how different groups might respond to a treatment or intervention.

Why that is important: Different populations may have different genetic, environmental, and lifestyle factors that can affect how they respond to treatments. Including diverse groups helps identify these differences and tailor treatments accordingly. In fact, research has found that not all people react or respond to a drug in the same ways. For example, researchers have demonstrated that many groups underrepresented and traditionally excluded in clinical research can have distinct disease presentations or health circumstances that affect how they will respond to an investigational drug or therapy; therefore, excluding them from clinical trials can have devastating (and costly) outcomes. 

Some examples of the imperativeness of clinical trials to determine how different populations respond to treatments include: 

• The HLA-B57:01 allele, a genetic marker, is strongly associated with hypersensitivity reactions to the HIV medication abacavir, and its prevalence varies across different ethnicities. As a result of previous trials and research, we know that approximately 6% of Caucasians and 2-3% of individuals of African descent carry this allele, which can cause significant – even fatal – reactions. Therefore, screening for HLA-B57:01 before starting abacavir is recommended for all individuals.
• In Hepatitis C (HCV) treatment, the IL28B gene (specifically, the CC genotype) plays a significant role in determining a patient’s response to interferon-based therapies, like pegylated interferon and ribavirin. Individuals with the CC genotype are more likely to achieve a sustained virologic response (SVR) – in other words, the virus is cleared – compared to those with CT or TT genotypes. African Americans are less likely to have the favorable CC genotype (for the rs12979860 SNP) compared to individuals of other racial and ethnic backgrounds.
• Aliskiren, a renin inhibitor used to treat hypertension, may have a reduced effect in African American patients compared to other racial groups. While aliskiren has shown efficacy in this population, a pooled analysis of clinical trials indicated a lower antihypertensive effect in African Americans than in Asian or white patients. 

Currently in the U.S., 30 to 40% of the population are minorities, while 80 percent of clinical trial participants are white and only 45 percent are women. These examples demonstrate the importance of having data that represents the entire U.S. population. When researchers look to study how genetic variations, or differences in a person’s biological makeup, can influence how the body responds to drugs – pharmacogenomics – we need to ensure we include all populations. 

We must continue to identify and address barriers to inclusive trials  

Today, there are a number of obstacles that stand in the way of trials being more inclusive:  

• Language barriers (consent documents/language in other languages) 
• Gender (can be harder to enroll women who are in charge of childcare, family care, etc.) 
• Mistrust (takes longer to build trust and rapport in certain communities)  

It’s important to note that those aforementioned obstacles can be overcome with intentional efforts.  

First, include languages other than English on materials, including consent forms, with a focus on the community surrounding a clinical trial site. For example, if there is a large Spanish-speaking population, make sure materials are in both English and Spanish. 

Second, offer flexible hours and on-site care options to improve accessibility for those with children and/or alternate (i.e., non 9-5) work schedules. 

Third, ensure the tone – in all materials and from all staff – is one of trust. Include FAQs that not only address logistics, but get to the heart of why an individual might not trust the healthcare system and why their participation is important. 

Inclusive trial design and execution is critical for progress 

Our collective goal should be to conduct clinical trials that look like the population, so that we can get to a future where the drugs and therapies we develop work optimally for every patient. Therefore, we need to understand that even if cuts do not directly impact a specific trial, participants may be affected, such as by larger economic changes. It’s important that we start now to operationalize teams’ ability to account for the changes and shifts in participants’ lives that may impact their participation. 

The current focus on cuts doesn’t have to have a devastating impact on the way we run clinical trials, but it does require us to be intentional with the way we design every trial; the actions we take; and how we build trust with, communicate to and engage communities. Ensuring that all segments of the population are represented in clinical trials promotes and helps to ensure that all groups benefit from advances in medical research and that no group is disproportionately affected by adverse effects. By understanding how different populations respond to treatments, healthcare providers can make more informed decisions, leading to improved health outcomes for all groups.