Experts' Perspective: How a Historic Lack of Diversity Manifests in Real-World Care

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In part 1 of our 3-part series on the impact of clinical trials lacking diversity, we are spotlighting responses to our first question, which sought to encapsulate the perspectives of our group of experts on how a historic lack of diversity in clinical trials has manifested itself in today’s care of patients from diverse backgrounds.

In recognition of the close Black History Month, the editorial staff of HCPLive interviewed clinicians of color across more than half a dozen specialties and asked how a lack of clinical trial diversity has impacted their specialties as well as the real-world care of patients. In this series, we posed our group of experts a series of 3 questions about the historic lack of diversity, how it manifests in today’s care, and what the future might look like if left unchecked.

In this portion of the series, we are spotlighting responses to our first question, which sought to encapsulate the perspectives of our group of experts on how a historic lack of diversity in clinical trials has manifested itself in today’s care of patients from diverse backgrounds. These responses are highlighted in the following video and transcribed below.

For more from this series: Experts' Perspectives: How Lacking Clinical Trial Diversity Impacts Public Health

HCPLive: How has the historical lack of diversity in clinical trials affected your specialty, and what specific challenges has it posed in delivering equitable healthcare outcomes for all patients within your field?

Nasrien Ibrahim, MD, MPH: So, if you look at the landscape of cardiology trials, specifically with heart failure and transplant, but really across all of cardiology, the enrollment of Black patients specifically, has been dismal. And other racial and ethnic minority populations as well, including American Indians, Hispanic or Latin X populations, and of course, women, we know less women are enrolled into clinical trials. And I think the biggest issue with that is that we create these guidelines that apply to everyone based on these groundbreaking trials, but the trials are not representing the patient population, but we make these recommendations that are supposed to apply to everyone. And so, you know, the lack of diversity is just telling you, you're looking only at one specific patient population, which is white men, that's the majority of patients are enrolled or individuals that are enrolled in trials. And so to me, it's how do you translate this to the real world when the clinical trials don't really represent the real world.

Ashwin Ananthakrishnan, MD, MBBS, MPH: The issue of racial and ethnic underrepresentation in clinical trials within gastroenterology is a critical concern with significant implications for patient care. Historically, clinical trials have been conducted for over 70 years, but it is becoming increasingly evident that the patient populations enrolled in these trials may not accurately mirror the diversity of the United States population.

This lack of representation is particularly concerning due to several reasons. Firstly, there may be biologic differences between racial and ethnic groups, leading to variations in treatment response and side effects. Without adequate representation in clinical trials, it becomes challenging to generalize the efficacy and safety of treatments across diverse patient populations accurately. This can result in inequitable access to effective treatments and may lead to suboptimal care for certain racial and ethnic groups.

Furthermore, clinical trials often serve as a crucial source of treatment for refractory patients who have exhausted standard-of-care options. Inadequate representation in trials means that certain racial and ethnic groups may be denied access to potentially life-saving treatments when they are failing standard therapies.

To address these issues, the gastroenterology field needs to recognize the value of racial and ethnic diversity in clinical trials. By ensuring diverse representation, researchers can generate more accurate and generalizable data, leading to equitable access to effective treatments for all patients. Additionally, efforts should be made to improve outreach and recruitment strategies to increase diversity in clinical trial participation, thereby addressing disparities in healthcare and advancing patient-centered care in gastroenterology.

Maya Clark-Cutaia, RN, MSN, PhD: I think, you know, the first part of that question really is an unfortunate one because minoritized groups are overrepresented in kidney disease and so the lack of representation then means that the experience of minoritized individuals whom this harm the most is poorly understood, but it goes even a bit further because then we also don't understand the social cultural impacts of that and how systemic and structural racism as well as discrimination really impacts the interventions and medications that we want to provide to these patients. So, really understanding how to meet them where they are isn't necessarily happening.

Luisa N. Borrell, DDS, PhD: I can inform you that certain asthma medications are tested and developed primarily with the White population in mind. However, when administered to African American children, they often prove ineffective. It is noteworthy that African American and Puerto Rican populations in the US exhibit a higher prevalence of asthma. An intriguing aspect of this disparity lies in the environmental factors associated with their residential areas. Many African American and Puerto Rican individuals reside in urban neighborhoods, including public housing projects or areas near highways. Consequently, these communities are exposed to higher levels of air pollution stemming from vehicle emissions, which significantly impacts the air quality children are exposed to. Moreover, issues such as inadequate sanitation practices, including delayed garbage collection, contribute to conditions conducive to pest infestations, such as roaches. These pests harbor allergens that exacerbate asthma symptoms and hinder overall asthma control in children.

Eleesha Ellis-Cox, MD, MPH: Consider the multitude of factors influencing mental health, ranging from trauma, grief, and social isolation to genetics and family history. Additionally, racism and discrimination exert significant impacts on mental well-being. Despite the Black population comprising approximately 13 to 15% of the US demographic, their representation in clinical trials typically ranges from only five to 8%. While it may be tempting to attribute this underrepresentation to a lack of interest, such assumptions fail to capture the full narrative.

Consequently, clinical trials often lack diversity, undermining the validity of their findings. Failure to consider the effects of prolonged stress, particularly elevated cortisol levels resulting from experiences of racism and discrimination, further compromises the efficacy of treatments. Consequently, what may appear to be evidence-based interventions often overlook crucial physiological factors, rendering them ineffective for a diverse population.

By predominantly including white participants, these trials fail to accurately represent the broader demographic landscape. As a result, the efficacy and applicability of treatments are skewed, marginalizing Black and brown communities. It is imperative to acknowledge and address these disparities to develop truly inclusive and effective mental health interventions.

Ashira Blazer, MD, MSCI: In rheumatology, as in many other medical specialties, there exists a notable lack of diversity, which is particularly pronounced for several reasons. Firstly, the rarity of rheumatic diseases results in a smaller patient population compared to conditions like hypertension or diabetes, making it challenging to recruit participants for clinical trials. Additionally, these trials are often conducted in large academic centers that may not be easily accessible to underprivileged and underserved populations, further exacerbating the issue.

This lack of diversity in clinical trial participants is especially concerning in diseases such as lupus, where the majority of patients are people of color, yet the majority of trial participants are white. Consequently, our understanding of how lupus manifests and responds to treatment in a broader, more diverse patient population is limited.

Moreover, when considering the nuances of rheumatic diseases, such as lupus, it is essential to recognize the diverse range of symptoms experienced by patients. While inflammatory conditions like lupus activity scores are crucial for assessing disease severity, there are also type two symptoms such as pain, depression, and fibromyalgia that are less directly tied to inflammation and are challenging to manage. Furthermore, the expression of these symptoms is often influenced by cultural factors, making it even more complex to understand and address the needs of a diverse patient population. Efforts to broaden the scope of clinical trials and incorporate diverse perspectives are crucial for improving our understanding and management of rheumatic diseases.

Girardin Jean-Louis, PhD: I became aware of differences between Black, White, Latino, and Latina individuals in terms of sleep duration and quality, particularly from 1990 to 1999. At that time, the discussion wasn't focused on disparities per se, but rather on recognizing and understanding these differences. There was consideration as to whether these differences could stem from specific environmental factors or policies that may favor one racial or ethnic group over another. The distinction between disparities and differences was pivotal, as it highlighted the potential connection between observed variations and underlying policies or environmental influences.

Initially, my observations were centered on these differences in sleep patterns, but over time, it became evident that similar disparities existed in other health domains, including blood pressure, HIV, cancer, diabetes, and heart disease. Additionally, variations in sleep and circadian rhythms also emerged as areas of concern. Consequently, the concept of sleep equity gained prominence, leading to the development of a dedicated field aimed at addressing these disparities.

This realization had a profound impact beyond my career choices. It prompted a broader commitment to addressing health disparities by not only pursuing research in this area but also by providing training opportunities for others interested in health equity. By empowering individuals to become health disparities researchers, we aim to contribute to a more equitable healthcare landscape and foster meaningful change in addressing disparities across various health conditions and domains.