Diversity in Research

Podcast Transcript

Announcer:

Welcome to Love Your Heart, brought to you by Cleveland Clinic's Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute. These podcasts will help you learn more about your heart, thoracic, and vascular systems, ways to stay healthy, and information about diseases and treatment options. Enjoy!

Lee Kirksey, MD:

Welcome everyone. My name is Lee Kirksey. I'm a vascular surgeon here in our Heart, Vascular & Thoracic Institute at the Cleveland Clinic. I am the Chief Health Equity Officer and Community Engagement Head in our Heart, Vascular & Thoracic Institute. So we're so excited to be here today, Sherelle Tucker and I, to discuss clinical trial involvement and how we might go about that in some historical underpinnings.

Sherelle Tucker:

Thank you, Dr. Kirksey. I'm Sherelle Tucker. I'm the Administrator for Community Health Equity here at the Cleveland Clinic, and I'm just really happy to have a conversation with you today on this subject that I think is so important and the importance of African-Americans, men, women, our Hispanic friends also participating in research and why it's important to do so.

Lee Kirksey, MD:

That's exactly the focus, and our challenges with clinical trial diversity and research diversity are longstanding. So maybe that's where we can begin this discussion.

Sherelle Tucker:

Absolutely. So, Dr. Kirksey, I just want to ask you to share a bit. We've had some conversations together on this topic, and one of the things that I thought would be really important is just to touch on something that's near and dear to you and your specialty. So can you speak a little bit about heart disease, healthy hearts, what we need to do, why, and how it's impacting the minority populations?

Lee Kirksey, MD:

Absolutely. That's a great place to begin. I will say that cardiovascular disease has an inordinately high burden within our Black American community, with our Hispanic American community. We don't have a large indigenous population here in Northeast Ohio, but certainly that population is impacted as well. Maybe the first place to begin is, "What is cardiovascular disease?" And many people hear that term, and they understand what it means, but not necessarily in detail. The way I describe heart and vascular disease, cardiovascular disease, is everyone's had a family member that has a heart attack, has had a heart attack or a stroke, and so that's coronary artery disease. We also think of patients that have valvular abnormalities like aortic stenosis or aortic regurgitation. That's another component of cardiovascular disease. Then we have patients that have a heart failure or arrhythmias. All of these disorders disproportionately impact our Black American community on the order in most instances, of two- or three-times greater risk of having a heart attack or two- to three-times greater risk of having heart failure as an example.

Not only are these diseases more common within our community, but the outcomes once one experiences one of these diseases are worse than they are in other communities, the White American community. So that is really the lens through which we view cardiovascular disparities. We think about hypertension, high cholesterol, diabetes. These are all chronic conditions that lead to cardiovascular disease. So we think about end-stage renal disease. That's something people forget, is a consequence of having these chronic medical conditions that cause cardiovascular disease. Limb amputation, patients that have peripheral artery disease, or PAD, as it's known, are at increased risk of having disability and losing their limbs. This is more common within our Black American community. We have data showing that Black men are at two to four times higher risk of undergoing lower extremity amputation due to cardiovascular disease, diabetes, and these disorders. So I hope that paints to all of you how important it is that we address these health disparities, the underlying social determinants of health, and the poor outcomes that we disproportionately experience within our community.

Sherelle Tucker:

So, Dr. Kirksey, you're a vascular surgeon, so there are a number of treatments that you provide on a daily basis to address the needs of those who are dealing with vascular disease. One of the things that we are here to talk about today is research. We both know that there is a larger number of White men who participate in clinical trials and research and that there's a need for more of those who look like us to participate. Can you talk a bit about that, why it's important for African-Americans and Hispanic Americans to participate in clinical trials in research, and the benefit of doing so?

Lee Kirksey, MD:

Yeah, that's a great question, Sherelle. When we think about research, that term in and of itself has some connotations. So we can talk about clinical exploration. We can talk about clinical investigation. It's all under that umbrella. The point that you make that historically, clinical trials, and when we think about clinical trials, we usually think about medications. Maybe it's pharmaceutical clinical trials like blood pressure medication. Maybe it's medical devices, procedures to treat patients. Those clinical trials have historically included a disproportionately high number of White men. They've lacked having gender diversity, and they've definitely lacked having racial and ethnic diversity, especially across Black and Hispanic Americans. Why is this important? It's because when we think about a pharmaceutical trial or a medical device trial, the results that come from that trial are likely to be attributable to the greater population. So if we have a clinical trial and we've not had enough Black Americans, Hispanic Americans, women, or some variation of all of those demographics within the clinical trial, it's hard for us to generalize, that's the medical term we use, to the entire population.

So we have a history of medications that had a clinical trial performed with a high number of White men, and then once the medication was used within the general population, we saw that there were non-responders within the Black American population. The medication certainly worked very well in the Black American population, but there was a small percentage of patients that did not respond as well. With that information, that just means that we need to do the appropriate testing once we initiate this medication to make sure that an individual is responding. That's a perfect example of why it's so important to have diversity within clinical trials so that we are able to utilize these medications or these medical devices with the expected good outcomes in every patient population.

Sherelle Tucker:

I do have one last comment/question I want to ask you to answer. So we know that there's huge distrust. There has been distrust as far as African Americans in participating in research. We know historically, we've heard of the different research studies that have been conducted on African-Americans and those outcomes. So can you speak to where we are today in 2024 as we look to increase the number of African Americans, Hispanic Americans participating in clinical trials or research studies? What's in place now to prevent those things that have happened in the past from reoccurring?

Lee Kirksey, MD:

Yes, Ms. Tucker. That's a great question, and it's probably beyond the scope or the length of time that we have here to go back through this long history of why there is mistrust and distrust within our community. I'm old enough to have grown up in an era when I heard from my parents and grandparents, and the trial that's most commonly mentioned is the US public health trial at Tuskegee Institute. I no longer even call it the Tuskegee trial because Tuskegee has many, many great things that are attributed to Tuskegee University. I don't think this trial should define Tuskegee University, but it was a US public health trial at the Tuskegee University that everyone talks about when we think about mistrust. But there are far, far more events and some that have happened recently that give grounds to why people have mistrust of whether it's healthcare institutions, whether it's government agencies that run clinical trial.

What I can say about clinical trials these days is that we have various mechanisms of controlling how those clinical trials are conducted, the safety of those clinical trials that's overseen by our Food and Drug Administration, the FDA as it's known. We have within our institutions, within our healthcare systems, Institutional Review Boards, or the IRB as it's known, which is charged with creating a safe implementation of clinical trials to, at the very core, protect the potential enrollee for the clinical trial.

What I try to emphasize to my patients as a practicing surgeon is that in many instances, a clinical trial, whether it's a medication or whether it's a medical device, may represent a key opportunity for a patient or my family member to have access to one of a few opportunities to treat a disease state. Whether one has cancer, many times we're trying to determine how effective, and many of our treatments are rolled out first through well-controlled clinical trials, or it's a medical device. Accessing that treatment early enough to provide effective management of cancer or cardiovascular disease may be the best hope to achieve a good outcome for a disease state. So that's one reason it's important.

The second reason it's important is that in some clinical trials, we actually need healthy patients to perform those clinical trials and to deliver outcomes across healthy patients. So while in that trial, I, as a person enrolling in the trial, may not have any immediate benefit to a medication or some other investigational intervention. It may benefit one of my family members. For that reason, it's so critically important that we, from a community of Black, Hispanic Americans, enroll within that type of trial so that our children or our grandchildren benefit from understanding how that intervention might work within our community.

Sherelle Tucker:

I think this conversation is one that we need to continue. I hope that this is not the last time that you and I can come together and talk through this because I think we're just touching the top layer of research, clinical trials, and involvement and why it's important. So I just want to thank you for your time. Thank you for the conversation, and again, let's keep this conversation going and come back together soon.

Lee Kirksey, MD:

I agree with you 100%, Ms. Tucker. It's not transactional. This is building a relationship, and relationships are not built over a short and single interaction. It's built over time. So hopefully, you and I will be able to continue this conversation to share with our community why we are so invested in educating, communicating to our community about how important clinical trial diversity is. So thanks again for your time.

Announcer:

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