Engaging Native Hawaiian Communities in Clinical Trials
For Asian American, Native Hawaiian, and Pacific Islander Heritage Month, Dr. Christine Lee speaks with Dr. Todd Seto and Dr. Deborah Taira about their research with the Hawaii Health Equity Research and Outreach Network, also known as Hawaii HERON.
Health Equity Forum Podcast: Episode 15 - Transcript
Dr. Christine Lee: Hello and welcome to the Health Equity Forum podcast, hosted by the FDA Office of Minority Health and Health Equity. I'm your host, Dr. Christine Lee, the Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at FDA.
As we celebrate Asian American, Native Hawaiian, and Pacific Islander Heritage month this May, I am pleased to welcome to the podcast Dr. Todd Seto and Dr. Deborah Taira to discuss the research with the Hawaii Health Equity Research and Outreach Network, also known as Hawaii HERON.
Their work under this project aims to address and reduce health disparities experienced by Asian and Native Hawaiian and Pacific Islander communities.
Dr. Todd Seto is a practicing cardiologist, and is the Director of Academic Affairs at the Queen's Health System or QHS. And professor and vice chair of the Department of Medicine at the University of Hawaii John A. Burns School of Medicine.
At QHS, Dr. Seto directs the clinical trials office which has enrolled Asian American, Native Hawaiian, and Pacific Islander patients for over 20 years.
Throughout his career, Dr. Seto has led studies ranging from pharmaceutical devices, clinical trials, behavioral interventions, secondary analysis of administrative data sets, qualitative research, and community-based participatory research.
Dr. Deborah Taira is a professor and health economist within the Daniel K. Inouye College of Pharmacy at the University of Hawaii, and a senior scientist at the Queen's Medical Center.
She has extensive experience studying health equity issues for Asian American, Native Hawaiian, and Pacific Islander communities. And is passionate about improving access to clinical trials for AA, NHPI, rural, and other communities. She has published over a hundred peer-reviewed manuscripts related to cost, health outcomes, and health disparities affecting AA, NHPI populations.
Dr. Seto and Dr. Taira, welcome to the Health Equity Forum podcast, and thank you so much for joining us today.
Dr. Deborah Taira: Oh, thank you Dr. Lee for having us.
Dr. Todd Seto: Thank you.
Dr. Christine Lee: First off, I'd like to thank you both for the important work that you do. Can you please tell our listeners how you first became interested in health equity research? What inspired you to dedicate your career to these important issues? Deb, we can start with you and then Todd.
Dr. Deborah Taira: Sure. Well, my interest started a long, long time ago. My mother was actually a professor of nursing, and she used to go to elderly housing projects. And I remember she brought me along with her and I would go with her and she'd bring all her scales and things like that. And she said, "You can learn more in five minutes when you go into these people's homes. And you see in their fridge they don't have any food or the place is filthy or whatever. You learn more about what can help the patient by actually getting to know their life circumstances."
And in Hawaii we have really good health, so we have the highest life expectancy of any state in the U.S. However, there's huge health disparities. So unfortunately, Native Hawaiians live about 11 years less than Chinese in Hawaii. That's a huge disparity, and I just feel like that should not exist now, not in our state of Hawaii. And so, I'm passionate about trying to do what I can to correct that.
Dr. Todd Seto: As Deb mentioned, Hawaii is known as being the healthiest state in the U.S. We have a very long life expectancy, but we know that the disparities, in particular, as Deb mentioned with Native Hawaiians, as a cardiologist in the hospital, I saw that.
I saw it in the patients that were in the hospital for myself, heart disease. Native Hawaiian patients weren't necessarily on the optimal medications or didn't necessarily get the best practice devices or other therapies. And that was probably at least part of what's driving that differences in life expectancy and outcomes.
And trying to understand why those differences were there. It wasn't only because of patient factors, it wasn't only doctor factors. There's multiple other factors that may have led to that difference. And so, it became just a focus for me to understand the drivers behind that disparity. And the things I saw in the hospital were feeding into that perception.
Dr. Christine Lee: Can you please tell our listeners about the Hawaii Health Equity Research and Outreach Network, also known as Hawaii HERON?
Dr. Deborah Taira: Yeah. So, we're very pleased to be part of the REACH Consortium. And our project has multiple parts, but aim one is basically involving building infrastructure for clinical trials. And aim two is the pilot study that we've just completed, which was we interviewed Native Hawaiian, Pacific Islander, Filipino, and white patients who were hospitalized with diabetes.
And tried to understand, what were some of their, what was their overall level of interest in being in a clinical trial? What was their understanding of clinical trials? And also what is their trust in physicians and their beliefs about medication? And even more so, what kind of support would they need to participate in a clinical trial?
And so we found, we were just shocked by how excited they were about the idea of clinical trials. But one of the unfortunate things, getting back to the last question, was when we saw…first of all, there were so many Native Hawaiian and Pacific Islander patients with diabetes in the hospital. We couldn't find white patients (with diabetes). We had the hardest time. And the Native Hawaiians of Pacific Islanders were about 10 years younger. So not only are they having a high prevalence of disease, they're getting the disease in their 40s and 50s. And that's really concerning.
Dr. Todd Seto: We know that in clinical trials, there's a disparity in terms of participation. And we know that Native Hawaiians and Pacific Islanders are underrepresented in clinical trials. So one of the goals in Hawaii HERON as part of the REACH consortium, is to understand that disparity. Because I believe that ultimately that disparity, again, is another reason for that broader disparity we see in mortality. So the project that we're working on, as Dr. Taira was talking about, was to try to understand maybe the drivers of that disparity in clinical trials. Knowing that if we address that increased participation, increased familiarity with clinical trials, that that would ultimately line up and hopefully reduce the disparities that we see in that population.
Dr. Christine Lee: Thank you for that. I'll now ask you to explain more about the communities you are engaged with. Can you give us an idea of the people you speak with? And what did you discuss?
Dr. Deborah Taira: Sure. So we were talking to Native Hawaiian, Pacific Islander, Filipino, and white patients that were hospitalized with diabetes. And one thing that becomes very clear right away is how diverse they are in terms of the fact that Native Hawaiians, almost all of them were, actually all of them in our study were born in the U.S., they speak English. They knew what a clinical trial was, for the most part.
The Pacific Islander patients were from many islands throughout the Pacific, American Samoa, Western Samoa, Guam, Chuuk, Pompeii, Fiji. Many of them, English was not their first language. And for most of them, our first question was, "What do you think of when you hear the word clinical trial?"
And they had no idea what we were talking about. And so, we realized that the outreach would have to be different because if you have populations that have never even heard of a clinical trial, you need to do a lot more to lay the foundation before you can really try and recruit someone for a specific trial.
Dr. Todd Seto: The Native Hawaiian and Pacific Islander category is very, very broad. I think our study touched on that, in the sense that Native Hawaiians, you have a sense of who they are. But they're predominantly in Hawaii, a lot on the continental U.S. also.
The Pacific Islanders are from a vast part of the world in the Pacific that with many, many different islands, many different cultures, many different languages, who often come to Hawaii and to the continental U.S. to live and to work and be part of the U.S.
But they represent a very broad, diverse population that has many different languages, many different experiences going back through history, integration patterns, indigenous populations in their own right. Then you have the impact of the war, and then the relationship with the U.S, and then immigrating to United States or some being U.S. Citizens and coming to United States, coming to Hawaii to live.
And that mix is very diverse. And what we learned and are still trying to understand is how to reach out to them, how to make a relationship with them, how to have a presence in their community. And ultimately how to engage them into clinical trials so they can be more involved in our work.
Dr. Christine Lee: Earlier when we were talking, Deb, you mentioned that when you were talking about clinical trials with some of the communities, they thought it was criminal trials. They've never heard of clinical trials at all. So when you speak about the lack of knowledge and education, I think that in itself really strikes home that they may have never even come across this terminology.
Dr. Deborah Taira: Exactly. And I think the word trial, especially because clinical does sound a little criminal as well. And I think that they said, "Oh, somebody is in trouble." I was like, "Nobody's in trouble." And then it took me a minute to realize. And it wasn't just one person, it was several people. Just the word trial has a very negative initial reaction in many people.
Dr. Christine Lee: That's very interesting. Can you also give us an example of how you're supporting the expansion of culturally and linguistically tailored health education? What does that look like for one's community or the communities that you're serving?
Dr. Todd Seto: Our work is focused on trying to make clinical trials more familiar to our population, but also just good clinical care, as they’re related. And so, the question that we face is, how do we make the care that we provide, including clinical trials, more familiar and more relevant to the patients and community in Hawaii?
So part of it is working with people who are embedded in the community, people who are familiar with the community, people who are from the community. We know that primary care physicians are one of the main sources of trust for our population. And that's one of the common themes I think that we found in our work, across the different Native Hawaiian and Pacific Islander population, that trust with the primary care doctors or advanced practice providers. And we know that working with them, we were more likely to have success.
Part of our work also, on the research side, has been trying to make educational material, make treatment plans more familiar, and kind of more in the terms of patients. So, we have, storytelling, for example, is a popular way for us to communicate, and tell stories about the care that we receive as patients, how we manage to deal with difficult situations.
And have those stories be told to other patients in the community. And have them learn from other people just like them, what they did to take care of themselves. So really using the wisdom in a way within the community to help communicate with their families, their friends, and their neighbors. So different approaches in general, but the goal is to make research and clinical care. Again, which I feel it is very related and overlapping. Make it more familiar and make it more comfortable for our community members.
Dr. Deborah Taira: Yeah, I wanted to add something to that. I think when we think of culturally tailored, sometimes you think about having a picture of a Native Hawaiian person or using a certain word or whatever. But in our interviews, what we found was that I think what's culturally appropriate is really spending time with people. Not being rushed, listening to them, and responding to their questions in a very thoughtful and respectful manner. And that's what's culturally appropriate, more than just any specific word or picture.
Dr. Christine Lee: I would almost say it's culturally respectful. So no, that's a very good point there Deb. When we speak about expanding data availability, what does this mean for the communities that you serve?
Dr. Deborah Taira: Yeah, I feel for Native Hawaiians and Pacific Islanders in particular, there has been a long history of invisibility. Because they're often grouped, first of all with Asian Americans who have the longest life expectancy and very different issues. Or now, especially as Asian Americans are broken out, oftentimes Native Hawaiians and Pacific Islanders end up in another race category. And so, they still remain invisible. So not only do we have diversity within the community, we're not even looking at them separately.
So if you look at clinical trials that have been conducted, if you try and get data, it's almost impossible to get data on the number of Native Hawaiians or the number of Pacific Islanders that were in any specific trial. And if you do get it, the numbers are so small. Maybe like for a big diabetes medication, there's five that were in the country. Even though the prevalence is very high, many people are on these medications, none of them have really been tested in these populations.
Dr. Todd Seto: If you don't look at those populations, then I believe that's where disparities grow. And so what Deb is saying is that even though numbers are small, if we don't look for them, we don’t find them, we don't work with them, then the disparities that exist, we know they exist. And we can see it. We can see it in the patients in the hospital, as we're talking about for enrolling our clinical trials. If we don't look for them and we don't communicate with them and don't work with them, those disparities will at least persist, will probably worsen. And so thinking about clinical trials and thinking about clinical care and thinking about data, it's related. We need to find a population to work with them. And we need to work with them to reduce these disparities.
Dr. Christine Lee: What sorts of barriers to clinical trials were identified during the project? And did you find this consistent with your prior research?
Dr. Deborah Taira: Well, one of the biggest barriers, one of the questions we asked was, "Have you ever been asked to be in a clinical trial?" And we found with the white patients, they had all had some experience, or almost all of them had some experience of at least being asked, or knowing somebody that was in a trial. But the vast majority of Native Hawaiian and Pacific Islander patients said they were never asked to be in a trial. And so, this lack of availability is an issue. And I think it stems from the fact that there's not a great infrastructure in Hawaii. But what would you say, Todd?
Dr. Todd Seto: I think that the…we know that we need to communicate better. That's obvious. And we need to communicate better in order to gain the trust of patients enrolled in clinical trials, provide that care. The barrier is kind of understanding how to communicate and how to hardwire that communication. So just saying it isn't enough, and just going out once isn't enough or twice or three times. We have to be a continual presence in the community. And we have to have an infrastructure to support that communication.
And that means engaging with our primary care physicians and nurse practitioners and other care providers. That means having some mentorship and training for research associates, for nurses, for medical assistants in how to do clinical trials, how to do research. That means having better data systems. That means sharing resources because it's hard to have those resources and so on. So it's communication, but it's really kind of, how do you hardwire, how do you build infrastructure for that communication? And that ultimately, I believe, is one of the biggest barriers for these disparities that we see.
Dr. Christine Lee: This leads to the next question in which, what do you believe are some of the most promising proposed solutions or facilitators of participation in clinical trials that have emerged in your interviews?
Dr. Deborah Taira: Yeah. So the first one was, we found enormous trust in providers. We asked patients, "Do you trust your doctor to do what's best for your health?" And 85% of them said yes. And so we believe that engaging their, not just primary care providers, but they might be their cardiologist or whoever they see often, I think is a big… would really help improve recruitment and retention.
We had one patient that said she was approached by her endocrinologist to join a clinical trial, and her PCP (primary care provider) said, "Don't do it. You don't want to try a new medication that hasn't been tested." And so we found that if the PCPs are telling them not to participate in the clinical trial, they're not going to participate in the clinical trial. So, we need outreach and education for the primary care providers. And we feel like some of that could be done through the John A. Burns School of Medicine at the University of Hawaii. So, come up with a curriculum for that.
Second, we feel like there has to be mentorship and training for clinical research associates, for investigators, for administrative staff, like all across the board. Third, I would say we need shared support for clinical trials. So something like a pool of clinical research associates that could support multiple trials. Because every investigator isn't going to have the resources to hire people for every trial, because we're not enrolling thousands of people. So, something like that. And fourth, I think, is a data system that will support clinical trials so someone would be aware of these are all the clinical trials that are enrolling patients in Hawaii. Do you have any eligible patients? So, I think those are sort of the four main points.
Dr. Christine Lee: As you're considering these findings, how do you see this work support your efforts to continue to advance health equity?
Dr. Todd Seto: The main finding, which is both surprising and not surprising, is how interested and eager the patients that we saw, Native Hawaiian and Pacific Islander patients, were to enroll or engage in clinical trials. It was overwhelmingly positive. So for us going forward, it's taking that momentum in a way, and building on it.
There's a sense that maybe a bias or perception from a lot of physicians, like myself and my colleagues, that Native Hawaiians and Pacific Islanders are fearful or don't have that trust of doctors or of science. And that, I found, is not true. And so, it's taking that momentum and interest and eagerness in clinical trials and building that structure to communicate with the community. And to really engage with the physicians and other providers that Deb was talking about. So it's continuing that work, building that research.
And the question I guess is, how do you build a community-based research portfolio or clinical trial system? What does that look like? What are the components of that? And I think that trying to build on that trust and that relationship and solidify that communication process is really the first step that we have to take.
Dr. Christine Lee: Thank you so much, Dr. Seto and Dr. Taira, for being with us today. And thank you both for your leadership on this project. We truly appreciate the opportunity to collaborate with you on this important work.
Dr. Deborah Taira: Well, thank you and thank the FDA for all the support.
Dr. Todd Seto: Thank you.
Dr. Christine Lee: I will also want to let our listeners know if they would like more information about the Health Equity Forum podcast series, visit our website at www.fda.gov/HealthEquity. While you're there, check out our library of resources and sign up for our newsletter. Also, don't forget to follow us on X, @FDAHealthEquity. Remember, working together we can create a world where health equity is a reality for all. Happy Asian American, Native Hawaiian, and Pacific Islander Heritage Month.