Politics

Will COVID-19 Clinical Trials Manage to Include Black Patients?

One of the most affected demographics is one of the most likely to miss out on drug or vaccine studies.

A man walks into a tent to be tested for COVID-19 at a mobile testing station in a public school parking area in Compton.
A man walks into a tent to be tested for COVID-19 at a mobile testing station in a public school parking area in Compton.
ROBYN BECK/Getty Images

Calethia Hodges wants the people in her community to know what’s going on with their bodies. As the director of clinical operations for Infinite Clinical Trials, a 4,000-square-foot research facility in Morrow, Georgia, on the southeastern edge of the Atlanta metro area, Hodges spends a lot of time and resources attempting to recruit Black people for clinical medical trials—a demographic that is woefully underrepresented, even if the illness that researchers are attempting to treat disproportionately affects them.

In general, people may be drawn to enroll in clinical trials for a chance at accessing an experimental treatment that could extend or improve their lives. For Black patients, it gets more complicated when the history of medical experimentation is considered. There’s a deep, understandable mistrust of medical institutions within the Black community and this is often compounded by informational and financial barriers.

But the current coronavirus pandemic makes Black participation in such trials even more pressing. Evidence shows that drugs could produce different effects on different populations due to varying socioeconomic and environmental factors. And, across the nation, Black people are more likely to be infected with COVID-19 and are dying more frequently from complications of the virus. The pattern holds true in Georgia.

Getting people to be part of a trial, Hodges said, could save a number of Black lives, while ensuring that a safe, effective treatment for COVID-19 hits the market. “I’m always trying to recruit people for studies because we see the data, we see really their results,” she said. “And it’s a lesson that we can help people in that way.”

The patients served by Hodges’ clinic often don’t always have insurance and thus aren’t accustomed to receiving routine medical care and testing, something her clinic provides during the course of a trial. So if an experimental treatment doesn’t end up working, it’s an avenue toward something that could—even if it just opens the door for patients to develop a stable treatment plan with a physician. The clinic hasn’t started their clinical work against COVID-19 yet, but Hodges is working toward running two treatment studies and one vaccine trial.

We chatted about the role of clinical trials in vaccine and treatment development, how she convinces skeptical Black folks to participate and how that participation can work toward a greater good.

What role do clinical trials play in the creation of a vaccine for COVID-19?

So, with clinical trials, the first step is that they have the animals in the labs and they will test the vaccine on them to determine if it’s safe and effective. Then the FDA will say, “Okay, we will approve this drug so that it can move into human trials.”

Then from there there are three phases. Phase one includes less than 100 people. Phase two, is generally 100 plus people, and phase three involves 1,000 people. And they look at the results, usually for about 18 months, but with this pandemic everything is rushed. That’s where we are now. We’re looking at about four to five months to be conducting a vaccine study.

How do you get black people on board for clinical trials? Because, to be honest, I don’t know if you could ever convince me to be a part of one. I’m very skeptical.

Oh my goodness. If you look at the data, I mean God, there’s so many people that benefit from clinical trials. Are you on any medications?

No, not right now. I just take ibuprofen and sumatriptan for migraines.

Okay. Just think about a cancer patient who has done chemo and radiation. Then they tell the patient, there’s nothing else we can do for you. Guess what they do? They often turn towards a clinical trial. Sometimes it’s people’s last hope when they have chronic illnesses. I mean, COVID-19, it’s like, would you rather try a drug or rely on the ventilator?

I think, especially for Black folks, because we have this sordid history of being used as guinea pigs—most prominently Tuskegee, but also incidents like unwelcome plutonium testing—it’s hard to lessen community skepticism. So how do you get Black folks who are aware of this history and, because of that, they would rather not participate, on board? 

That’s why we are located where we’re located. I chose to be on this side of town to be around our people. I started off in Peachtree City where it’s predominantly white, where most people have insurance so they would rather just go get something that’s already on the market. In this community, you have a lot of people who do not have medical insurance. So when they come into our clinics, not only are they getting education, but they’re getting free treatment.

I mention drugs that they may currently be taking, or other drugs that are well-known just to let them know every drug that’s on the market has been through a clinical trial. And the only way that it goes to market is if it’s proven to be safe and effective. So if they are seeing too many negative results from it, they pull it. And I give them examples of some of the studies that we do and that they’ll likely see great results from it.

They’re monitored more closely than they would be if they were going to their doctor’s office and we explain that to them. When you get into a clinical study, you have to be at your visits. Every four to six weeks, you’re getting blood work.

We got a hot flash study where women are coming in and are so thankful for getting pap smears, mammograms and DEXA to monitor their bone density. All of this is at no cost to them. They get a free medication that they’re seeing really good results from plus they get a payment.

We do health fairs and we have community-based speakers. We do doctor to doctor letters, e-newsletters, we do stuff on social media. We offer transportation for people who don’t have cars. So when we contact the patients, we go over the benefits and the risks and tell them what all we offer them in return.

Since COVID-19 is disproportionately affecting Black people, how will it benefit Black people to be a part of these vaccine trials? More explicitly, do you think that it would save more Black lives?

Unfortunately, Black people may be disproportionately excluded from the initial vaccine trials because you can’t have any underlying issues.

But we still need more African Americans in these drug treatment studies because the data is crucial. That information, the safety assessments—we need more African Americans to make sure that this data is fit for everyone and not just the white people.

I have family who are skeptical of vaccinations. But I had to explain to them that I understand the fear, but when you look at the landscape of who it’s killing, Black folks stand to benefit the most by being vaccinated. Is that something that you try to explain to people yourself?

It’s either that or stay in the house. I mean, and we can’t keep living like this. We just cannot hide behind our windows. You want some type of comfort. Would you rather go out and just wear a mask for the next however many months? Or know that you’ve done something as far as getting a vaccine and you’re wearing a mask? It’s another layer of protection.

And when Black people are a part of clinical trials, how does that give us a more comprehensive view of the data? And what’s the issue with mostly white people being part of clinical trials?

Because they don’t have as many issues. We’re in that higher risk group, and it’s not enough of that information being examined. White people are also more educated on clinical trials and there’s more of a mistrust issue in the African American community. Even if you get placebo, or you get the medication and you’re not seeing complete results, if it makes it to the market that data can help someone else.

The idea of helping other Black people can be really appealing. I think it’s fascinating that you explain it that way. And so, when Black people who suffer from comorbidities are a part of clinical trials, does that give researchers a better idea of how a drug will affect vulnerable communities?

Yes, exactly. We have a wide age range, from 18 to 65, so that age range is there, and it’s for all people. But like I said, sometimes it’s just not enough African Americans involved.

Right. It’s interesting how it is a good thing for Black people to be involved in clinical trials and you have clinicians like yourself who want to make that happen. But you’re butting heads with hundreds of years of medical racism. 

I know several people that have flu-like symptoms, respiratory type issues, that went to the emergency room and they were turned away because it wasn’t severe enough. So the treatment study that we’re getting is not for those who are really critical, it’s for those with milder symptoms. Instead of just going back home and just quarantining for 14 days, here’s something you can take that might help. Your symptoms could be gone in three or four days versus going home, getting worse and then seven to eight days later you’re in the hospital on a ventilator.

Why is it important to improve the health of Black communities?

We need to be more aware of catching things early. So many people shy away from the doctor because they don’t have insurance or feel fine or the history. But regular testing is important for treatment. And to be on a stable treatment plan could prevent other illnesses from occurring.

And we share lab results with them that they can share with their doctors. For instance, you could come in for one study that you may not qualify for because of your lab results or some other type of tests. And one of those tests may show that you have something else going on. We’ve had to notify people of cancer or STDs and things like that that they just didn’t know about it.

The amount of people in my own life who I’ve had to convince to get comprehensive blood work at least once a year is astounding. Because, like you said, so many folks don’t understand why their doctor needs to run a full blood panel on them. And I’m like, “Because you need to know what’s going on!” You could have a B12 deficiency, thyroid issues or anything. 

Right, even though you feel fine. It’s always those underlying issues, you know?

What’s at stake for Black communities here?

Well, we all need to take our health more seriously. And if what’s going on is not an eye opener, then I don’t know what else is. COVID-19 can affect any of us, but it’s really affecting those with underlying conditions. I’ve been losing a lot of people in my family in Chicago. Why? Because they didn’t know about their underlying conditions.

The virus could attack any of us, but it’s going to attack all of us differently depending on what’s going on internally. And it takes medicine a while to come to the market. But this is your chance to take this drug now because it could take years before it’s marketed. So even if you don’t live to see that, at least it’ll help our next generation.