Experts' Perspectives: How Lack of Trial Diversity Impacts Treatment Development

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 pertaining to 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 second question, which addresses how the previously established lack of diversity in clinical trials has directly affected the development and application of new therapies or devices in real-world settings. 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: To what degree has the underrepresentation of diverse populations in clinical research impacted the development and application of medical treatments within your discipline?

_{^{(L to R): Arisha Blazer, MD; Eleesha Ellis-Cox, MD, MPH; Luisa N. Borrell, DDS, PhD; Nasrien Ibrahim, MD, MPH; Girardin Jean-Louis, PhD; Ashwin Ananthakrishnan, MD, MBBS, MPH; and Maya Clark-Cutaia, RN, MSN, PhD}}

Nasrien Ibrahim, MD, MPH: We make guidelines that apply to everybody based on trials that are not diverse whatsoever. So, you're taking a trial that has enrolled a majority of White men, and you're trying to apply what you find in these trials to everyone, including women who are underenrolled in clinical trials to Black patients to LatinX patients, and then to other patient populations.
To me, if you're creating a trial, you need to put in the effort upfront to try and make it look like what the general population looks like. We talk about ‘Okay, the US has majority white patient population’. However, when we look at who has the worst outcomes—Black patients have the worst cardiovascular outcomes, they have the highest heart failure-related cardiovascular mortality, they present sicker, they present earlier, and a myriad of other things too, including being less likely to be seen by cardiologists when admitted to the hospital. So, we're not studying this specific patient population, but we're applying what we found in a very nondiverse clinical trial to everyone.

Ashwin Ananthakrishnan, MD, MBBS, MPH: I think it has hampered in many ways and it means we are barred by lack of data. When we have certain populations under represented by trials, we just don't know if these drugs will work differently or better in them by understanding how the drugs may work differently in populations that may actually open the door for newer treatments in both those populations and in other populations. So, I think not having a diverse population really affects the current therapy being studied, but we also potentially impact future therapies.

Maia Cutaia-Clark: In terms of Black, Hispanic, and Asian patients, particularly Asian patients, there is a notable gap in research focusing on these minoritized groups due to their underrepresentation in clinical trials. While much is known about the effects of various medications and clinical interventions on typically white male populations, there remains uncertainty regarding how these findings translate to other demographic groups and how they influence behaviors within those communities.

This lack of understanding poses significant challenges, as it leads to generalizations based on limited data. It is crucial to recognize that what works for one population may not necessarily be effective or appropriate for others. For instance, while certain medications may demonstrate better efficacy in Black populations, the extent of this phenomenon, especially in conditions like kidney disease, is not well understood.

Luisa: Indeed, the impact of social determinants of health, particularly in densely populated urban areas like New York City, cannot be overstated. The correlation between zip code and health outcomes underscores the profound influence of socioeconomic and environmental factors on individual well-being. In neighborhoods such as the South Bronx, where asthma rates are notably high, these disparities are often attributed to a combination of socioeconomic challenges and adverse environmental conditions.

Stressors related to poverty, substance abuse, and neighborhood safety contribute to elevated levels of stress among residents, exacerbating health issues such as asthma. Moreover, research has revealed a concerning link between racial discrimination and asthma prevalence, particularly among African American children. Studies have shown that African American children who experience racial discrimination are twice as likely to develop asthma and experience poor asthma control compared to their counterparts

Ellis-Cox: I think it just limits the utility of the studies. Because, again, it does not reflect the population at hand, and so I don't always feel like the medications that I may be choosing are representative of the patients that are sitting in my office that I'm treating. You may be getting treatments that haven't really been tested in a broad patient population. And so if you're having negative outcomes, it's not clear if that's because the treatment is problematic, or because it wasn't fully studied in a way that was going to be helpful for the multitude of the population and not just in your group.

Blazer: When certain populations are underrepresented, it means we lack a wide spectrum of symptoms and a larger patient pool. Consequently, recruiting patients becomes more difficult when limited to a small subset. Additionally, understanding how various phenotypes in rheumatology may respond to certain medications becomes challenging. It's a dual challenge: not only do we struggle to find solutions for these patients, but we also face inefficiencies in drug development due to the inability to incorporate diverse patient populations.

Girardin: We now know fully that the whole idea of DEI and diversity is absolutely necessary. Now, there's a lot of effort being made from some companies or some well established folks saying that DEI does not really the word diversity, is that really real? But we know that's just not the case. It is true that not all the programs established there have borne fruit, but we just got started. So we've got to give them some time to make some adjustments so that the fruit of those efforts can be those that we're very proud of. That's going to happen at some point.

The reality of the situation is that diversity does benefit different institutions. If you say for instance, I'm going to have a community where only White folks belong to that community. There are certain perspectives that might come from a LatinX group, or Black or African American groups that I'm missing that could have influenced the final product such as a scientific paper, such as a policy affecting diabetes or high blood pressure. It's not just in terms of academia, it's the same thing in business system andschool system. We know when you got diverse points of view, it makes it much easier to come up with solutions that have direct relevance for particular human related problems. So diversity is important. It does matter because different viewpoints make it easier to come up with solutions that are a long term in their constituents.