Cultivating Inclusivity in Clinical Research

Narrator: 0:01

Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased evidence, proven facts powered by ENCOREncore Research Group and hosted by cardiologist and top medical researcher, Dr. Michael Koren.

Dr. Carolyn Tran: 0:17

Hi, I'm Dr Carolyn Tran. I'm one of the principal investigators at our site and I'm here with Antoinette Hi.

Antoinette Bailey: 0:24

I'm Antoinette Bailey and I am the Diversity, Equity and Inclusion Liaison for the ENCORE Research Group.

Dr. Carolyn Tran: 0:30

So Antoinette, tell me why is it important to have diversity in clinical research trials.

Antoinette Bailey: 0:37

Well, in clinical research, diversity is important. That's a very good question, because for healthcare, all people should be represented, right? So in clinical trials, just like in the real world, you want a certain percentage of a certain population, because anytime you show up or take medications, you know it's not for a certain population, it's for all people. So diversity, just like healthcare is for all people, so you want a representation of the community to participate in clinical trials.

Dr. Carolyn Tran: 1:14

And what are some of the benefits that people can get from participating in the trials?

Antoinette Bailey: 1:19

So the benefits of participating in a clinical trial would be you get additional oversight. As you know, physicians are board certified physicians and we're a multi-specialty facility here, so you get that additional oversight by seeing doctors here. We do labs when you're participating in clinical research. Some studies call for EKGs. Sometimes we do MRIs. We do specialty testing here as well. We have the study that we're currently enrolling for. It's the Lp(a) study. This is a test that physicians don't normally order, but it's a very important test. This is a test that we offer here as a part of our free screenings. So that's important. By participating, you know, you get those type of specialty testing that you wouldn't normally get by your physician.

Dr. Carolyn Tran: 2:15

Yes, and it's very true, because, as a physician, I can tell you it's sometimes very difficult to get the insurance companies to pay for some of these special tests, like the Lp(a) and, in our memory, studies for the Alzheimer's dementia patients. A lot of times those PET scans and MRIs are not approved by the insurance companies but they do get that as part of being in our studies, right?

Antoinette Bailey: 2:39

And in our study we do not build the insurance company, right? Yes, and these testing are done without needing permission from the insurance companies.

Narrator: 2:51

Yes, yes.

Antoinette Bailey: 2:53

So additional oversight by board-certified physicians. You're getting testing that doctors don't normally order and we don't build insurance.

Dr. Carolyn Tran: 3:02

Yes, so no cost, no insurance needed.

Antoinette Bailey: 3:05

And we pay participants. We pay the participants a stipend for their time and for participation and travel to our studies.

Dr. Carolyn Tran: 3:14

Yes, I know you've been out there in the community. Yes, what kind of challenges have you experienced with trying to recruit patients for more diverse backgrounds?

Antoinette Bailey: 3:24

Okay. Well, the one thing that I hear a lot is so you want me to be a guinea pig?

Dr. Carolyn Tran: 3:30

We do hear that a lot.

Antoinette Bailey: 3:31

Yes, that's the first thing that I hear. And then the next thing I'm challenged with is, you know, mistrust. You know patients will bring up the Tuskegee experiment and we do talk about that in our healthcare presentations. We do healthcare presentations as well. We go out, we educate the community as well. We talk on different subjects cancer, we talk about lupus, we talk about chiropractor hypertension, different studies that we're enrolling for but it's an education presentation as well. And we talk a research 101. And research 101, we talk about the Tuskegee. We talk about the mistrust. We acknowledge that there were atrocities in the past and how we've worked to overcome those atrocities. We now have the Belmont R eport, we have the IRB oversight, we have oversight by the FDA and, of course, the pharmaceutical companies. We're constantly monitored. Doctors come in, I would think about every six weeks to review the data, to make sure the data is accurate, to make sure that we're recruiting actual patients. The purpose of clinical trials two things One, we want to make sure that patients are safe. That's our number one priority. Safety is number one and number two is efficacy. We have to make sure the drug is safe and that it works. So those are some of the things that you know I promote to the community Education. We talk about the past. We want to earn their trust. We talk about the benefits of participating the additional oversight, the fact that we don't build insurance and the fact that we actually pay them for their time and travel compensation. That's a part some of the benefits of participating in clinical research.

Dr. Carolyn Tran: 5:25

Yes, and there's definitely by far more safety oversight in research than you would ever get in your private doctor's office.

Antoinette Bailey: 5:32

Exactly. I can just tell you I started in this role as a research participant. I mean, I was very excited to participate in research. I started with migraine studies and then I did a couple of GERD studies and that's how I started out in research, as a research assistant and because I believe in so much what I do, so it's not for me just, you know, preaching to the choir. I actually believe in what I do. My family participates in research. I can just tell you, this year my sister came in to qualify for a obesity study. She was diagnosed with diabetes. That was just this year. Her hemoglobin A1c was 7.2. So that's another one of those additional oversight. She's been going to her primary care doctor for two years. They never checked hemoglobin A1c.

Dr. Carolyn Tran: 6:26

So it was discovered during her study participation.

Antoinette Bailey: 6:29

Yes, of course she screened for the study, but that's that additional layer of oversight. So those are some of the things that I can appreciate as well. We did an outreach event in Orange Park, Active After 50. There was a patient that came through, a very nice lady. We drew glucose on her, hemoglobin A1c. We got a critical alert from LabCorp. Her glucose was 615. Oh my goodness. So those are the types of things that really I enjoy going out into the community Screenings that we offer. We do Lp(a), we do glucose, blood pressure checks, hemoglobin A1c and cholesterol panels. So, with that being said, you know, even out in the community we're providing additional oversight. With me on the team, we always have a doctor, one of the board certified physicians as well. So after the patients tested with their screen, we have them sit and talk to the doctor and I always advise them. This is a time you have one on one time with the board certified physician. If you have questions, this is a great opportunity to get those questions addressed. And if you're interested in going further, you know there are clinical trials where we have other board certified physicians and you get that same oversight. I mean, you get a chance to ask questions, and that's what I love so much, and we're advancing medicine.

Dr. Carolyn Tran: 8:02

Yes, and that is true from a physician's perspective. There's Definitely not the time constraints that I have in clinical practice. I do have more time to spend with the patients here.

Antoinette Bailey: 8:15

And that's what the investigators that go out with me on outreach that's what they love, because they're actually sitting and talking to those participants.

Dr. Carolyn Tran: 8:23

Yes, and we talked about some of the the personal benefits to the research participants. What benefits would that provide to their community by them participating in research?

Antoinette Bailey: 8:34

trials. Okay. So as far as the community is concerned, for example, we'll go back to the Lp(a). Lp( a) is a genetic marker cholesterol. So with going back they're allowed to. You know, they talk to their family members, talk to their friends, bring them in as well. The screening is free and that's a benefit as well. You're exposed to medications that are not yet on the market. So, for example, if you have a certain indication, you're getting exposed to this medication before it's FDA approved, of course, but at the same time you have an opportunity to benefit for something that is not yet FDA approved. So that's a benefit to the community. We educate as well. That's a benefit to the community. We go out to churches, we've gone out to expose, we're doing a veteran's benefit next year, we've done women's conferences, things of that nature. So we're, you know, all over in the community representing on core research group and talking about the benefits of participating in clinical research advancing medicine.

Dr. Carolyn Tran: 9:46

Yes, and you touched on earlier the fact that medicines are going to work differently in women and different ethnic groups. And unless we have these patients who are willing to volunteer, we're not going to find out that information.

Antoinette Bailey: 9:59

Right, that's what and we found out? Think back to just women. We learned through research that women present differently for heart disease than men. So how do you find these things out, participating in clinical research? So it may not benefit you right away, but think legacy. Think this may be a drug that your kids could benefit from, you know, in the future. So you know it may not help you right away, but you know it's still advancing medicine.

Dr. Carolyn Tran: 10:29

Yes, and it can be exciting to know later that you are a part of that. Right?

Antoinette Bailey: 10:34

In the bigger picture.

Dr. Carolyn Tran: 10:35

You are a part of bringing that to your family, to your future generations. Absolutely.

Antoinette Bailey: 10:41

And that was a draw for me and I think back when I participated, and then I would see the commercials on TV and it's like ah, I participated in that study, I helped to bring that drug to market. So it's like a personal reward as well.

Dr. Carolyn Tran: 10:57

Yes, Antoinette, I wanted to thank you for joining me today and sharing with me how important it is to reach out to the community and to find the diverse populations to volunteer for these research trials. You're doing very important work.

Antoinette Bailey: 11:11

Thank you, Dr Tran. Thank you for having me here. You know, the one thing that I've been told about clinical research and the reason I would say my population or my people don't participate is because we're we're not asked. So I feel it's important that we ask, and that's what we're doing without reach. We're going out and we're asking because it is important, very important message.

Dr. Carolyn Tran: 11:36

Thank you, yes, so please come join us. Thank you, thank you.

Narrator: 11:40

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