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Health Equity Forum Podcast: Episode 14 - Transcript

RDML Richardae Araojo: Hello and welcome to the Health Equity Forum podcast hosted by the FDA Office of Minority Health and Health Equity. I'm your host, Rear Admiral Richardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity.

In this episode, I will be speaking with Stephine “Steph” Poston and Dr. Myra Parker on their research concerning perceptions of clinical trials in American Indian communities in the Northern Plains. Doctor Myra Parker is an Associate Professor in the Department of Psychiatry and Behavioral Sciences and the University of Washington School of Medicine. She is an enrolled member of Three Affiliated Tribes, originally from the Fort Berthold Indian Reservation in North Dakota. Her research focuses on cultural adaptation of evidence-based interventions among American Indian and Alaska Native communities.

Steph Poston is the owner of Poston & Associates, a full-service Native woman owned communications firm. Steph is an enrolled citizen of the Pueblo of Sandia and is committed to inspiring indigenous communities through culturally sensitive community-based approaches. She is the project lead for the Indigenous Innovators Collaborative that was funded by the FDA Office of Minority Health and Health Equity.

I'm glad to welcome Steph and Myra to the Health Equity Forum podcast and thank you so much for being our guest today.

Dr. Myra Parker: Thank you.

Steph Poston: Thank you so much.

RDML Araojo: So, Steph, let's start with you. Can you please tell our listeners about the Indigenous Innovators Collaborative and highlight the types of projects that you lead?

Steph Poston: Yeah, super excited. Thank you for having us. We really appreciate it.

Some of the work that we are doing right now, as was mentioned earlier, working with OMHHE, is working with tribal communities around the areas of clinical trials and the perceptions and also looking at diabetes home devices and how to connect tribal people to those that can better their health overall and looking at the issue of gene therapy.

RDML Araojo: Great. Thank you so much, Steph. And Myra, I’ll turn to you now.

Can you explain more about the town halls that I believe you all will be hosting and who did you speak to and what did you discuss?

Dr. Myra Parker: Sure, yeah. Thank you. We talked with tribal college students, and we also talked with tribal college presidents and tribal leaders from several of the communities in the Northern plains. And we held them at a Tribal Leaders Summit earlier this year in September. And so we have three separate town hall meetings where we invited folks to attend and discussed some of the perceptions that folks have around clinical trials.

RDML Araojo: Thank you, Myra. So to both you and Steph, can you tell us whether there were any main themes that emerged during the conversations?

Steph Poston: I think Myra and Dr. Kip, the other colleague that’s on this initiative, they can talk in depth to that. But I think one of the big things is just really introducing Indian country, the Native American population to FDA and OMHHE. And so with that, I’ll turn it over to Myra to get more in depth as they were the ones working directly with those communities.

Dr. Myra Parker: Thanks, Steph. So I think the one thing that came through across all three groups that participated was that people are curious and want to know more about clinical trials. There's a strong interest in what clinical trials are able to provide to American Indians. And there's also recognition that access to medical care is still very limited in certain communities and that clinical trials may be a way to access some of the services that folks need that they might not normally be able to obtain in their local communities.

I think some of the other themes that came out were also a distrust on behalf of some folks about clinical trials and more broadly, medical care. There have been harms that have been perpetuated both within the medical arena by providers as well as by researchers in Indian country. And so the folks who participated, you know, talked about some of these things.

They talked about some of the distrust of doctors, and some noted that, you know, maybe this was a little bit misplaced because things have changed, you know, over the years and quality of care has improved. And at the same time, people still had had heard from relatives from other members of their community about some of these harms. And so, you know, it's important to address those in a very transparent way. When we kind of look down the road and think about how can we perhaps make clinical trials more available.

Some of the other issues that the tribal college presidents noted was the need for education around clinical trials and to be able to provide a lot of the materials in different modes, different types of communication. So not just, you know, printed manuscripts, but also infographics, some visual aids, videos, even, you know, spots on the radio and TV. Because people learn in different ways and sometimes they access the material more readily through some of these other types of modes that might not be used in other types of settings.

The other piece I think that came through with the tribal leadership was the need to honor tribal sovereignty and to respect that each of these tribal governments has the authority and also the responsibility to protect their citizens. And so it's important to go through the tribal government processes in order to conduct research within reservation communities.

And alongside that, there was also, by both the tribal college presidents and also the tribal leaders, a recognition that the existing infrastructure within some reservation communities simply isn't set up for implementation of clinical trials.

So, that would be another important consideration in order to ensure that these clinical trials, if they were to be implemented within reservation communities and more accessible to local populations, are equipped to do that in an equitable way where individuals are protected. That was also another theme that was common across the groups.

RDML Araojo: Thank you, Myra. It's really, you know, helpful to hear the different themes that you observed. And I'm wondering if you could dive a little bit deeper and talk to us a little bit about maybe some of the differences that you observed based off the feedback from the various different groups that participated during the town hall.

Dr. Myra Parker: Sure. Well, I think you know when you look at the responses, the tribal leadership was certainly more attuned to kind of some of the higher-level issues with regards to clinical trials implementation and some of the challenges associated with that.

And then the tribal college students were very much more in tune with some of the kind of day-to-day patient type issues that might come up in a clinical trial. So students were concerned about possible side effects from participating in a clinical trial and just the uncertainty of not really knowing what to do if some of those things were to arise. So for example, some students in particular mentioned the concern that, excuse me, that if they experience a side effect, they might not be able to access medical care in in their current setting. So they were concerned that if something urgent arose that they would not be able to see a provider in a timely way in order to get their issue addressed.

RDML Araojo: And you mentioned a little bit earlier about some of the perceptions related to clinical trials. What sorts of barriers to clinical trials were identified during the town hall meetings? And did you find this consistent with your prior research?

Dr. Myra Parker: Yeah, that's a great question. You know, one of the biggest themes that continually comes up with the research that I do is the barrier of transportation. And so if you look at a reservation community or an urban setting, transportation continues to be an issue and that's because it's expensive. It's expensive to own a car, it's expensive to pay for gas. It's challenging and difficult to take public transportation if it even exists in particular communities. And so that was also echoed here in the town halls that we held. Transportation was one of the number one barriers that folks noted to participation in clinical trials and that was consistent across the three groups.

So folks talked about the challenges of just getting around locally and transportation being a hidden cost that isn't always necessarily adequately compensated when it comes to incentives for participating in research. And so they noted that there was a real need to really take a deep dive into those potential costs of participation and to compensate folks for those costs so that they could actually meaningfully participate in the research. Other folks noted, and this was across the board with the students and also the tribal leaders, that a lot of times transportation costs were absorbed by family. So they noted that sometimes folks were able to access clinical trials in local urban areas, but these urban areas are still, you know, hundreds of miles away from their home community. And so families would pool together resources and be able to provide transportation to individuals who are accessing those clinical trials or other types of specialty medical care through the support of the family.

And so that was also another important aspect to implementation of clinical trials that tribal college presidents noted that they underscored that if clinical trials were going to be implemented within these remote communities, there was a need to have the infrastructure locally available so that individuals who are participating don't have to travel hundreds of miles in order to take part.

RDML Araojo: That's really helpful feedback. It's always important to know, you know, what are the barriers and finding solutions, you know, to overcome those barriers. And I wanted to see if you can highlight now a little bit more about any proposed solutions that emerge from the town hall meetings.

Dr. Myra Parker: There was a strong interest by all the participants in learning more and so to me, as a public health researcher, that speaks to making information available through different types of educational devices and by providing, you know, kind of all of the information in a very transparent easy-to-understand way. Individuals who participated talked about elders who were interested in participating in clinical trials and talked a little bit about how elders were actually willing to participate and interested. And so just understanding that there's a huge variety of folks who might be willing and interested to take part in clinical trials is important because then the educational materials that we developed need to address those different groups across all of the different communities so that they're able to access that information in a way that's comfortable and supportive to them in making their decision.

I think another piece that came through was that COVID-19, just the virtue of the pandemic having, you know, existed has in an odd way kind of opened some doors and thinking about clinical trials, there are sort of two sides to that coin. There were some concerns about, you know, the COVID-19 vaccines that we've seen, you know, around the world and sort of the concern of, side effects that I mentioned earlier. And there was also an understanding that there was a need to test potential interventions that might help support health and wellness around American Indian communities. And so there was an, a willingness and an interest in participating if participants knew that that was a possibility that that came out of the research.

So, those I think, bode well for, you know, developing some content that people within American Indian communities could access and come to some kind of decision around whether or not to participate.

RDML Araojo: Thank you, Myra. And you know we're really excited about the project and the progress with the project and just wanted to hear a little bit more about the next steps for the project now that the town hall meetings are over.

Dr. Myra Parker: Sure. Yeah, so, we talked as a team and because the content was so rich, and I think there are many nuances that came out of the discussions. And so we're in the process of developing a manuscript for a journal, and so that's one outcome.

The other is our community partners. We're really interested in also having some materials that they can then share with the tribal college students and presidents and also the tribal leaders, so that they can see a comprehensive summary of some of the feedback that we received at the town halls. And that's a feature of community based participatory research which is informing how we approach this project, so that we can ensure that everyone has equal access to the materials and the results of the project.

So, we're also in the process of discussing what that might look like and how we can share that information with community partners in a way that, you know, can help them perhaps write grant proposals or, you know, just sort of understand clinical trials a little bit more comprehensively, and maybe make some decisions in their own communities about different projects or programs they’d like to implement.

RDML Araojo: Thank you, Myra. And you know Steph and Myra, really wondering about your thoughts about how do you see this work supporting your efforts as you continue to work to advance health equity?

Steph Poston: Yeah, absolutely. Thank you for the question. Just being … I was one of the first directors of health for my own tribe and to seeing where we're at now and marrying the research with what's really happening on the ground.

But some of the things that I see promising are addressing digital equity is so important to addressing health equity, because of people don't have access to that telehealth, if they don't have access to even the … we're looking at like home devices, diabetes home devices, those are all connected to the Internet and use of electronics. And so how do we look at those two entities and really make a difference for Indian country, for the American Indian population here in our country.

So, it's exciting that Indian Country is curious and they're open to learning, lots of areas to build in the area of workforce. So I think these are exciting times to come up with really promising solutions that are long overdue. Thank you.

RDML Araojo: Thank you, Steph. And Myra, anything that you want to add? 

Dr. Myra Parker: I think for, I would echo what Steph mentioned. I think the, the interest in learning more was really exciting. And also, I think what was interesting that came out of some of the discussions was a, a recognition of the fact that there are clinical trials currently being implemented within these communities.

And by providing more accurate information and making it accessible to everyone across the community, we may be able to address some of the misconceptions that are out there around clinical trials and hopefully make them more accessible and help promote a better understanding of what the risks are and also what some of the benefits may be for communities in these areas.

RDML Araojo: Well, Steph and Myra, I cannot thank you enough for being with us today and thank you both for your leadership on this important project. We truly appreciate the opportunity to collaborate with you on this important work.

I also want to let our listeners know if they would like more information about the Health Equity Forum podcast series to visit our website at www.fda.gov/healthequity. And while you're there, check out our library of resources including information on clinical trial diversity and sign up for our newsletter.

Also, don't forget to follow us on Twitter @FDAHealthEquity.

Remember, working together, we can create a world where Health Equity is a reality for all.