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  1. Health Equity Forum Podcast

Toward Improving Race and Ethnicity Data in Health Care (RAISE)

In this episode, RDML Araojo speaks with Susan Winckler, Chief Executive Officer of the Reagan-Udall Foundation (RUF) for the FDA, and Carla Rodriguez, RUF Director of Research, on the Real-World Accelerator to Improve the Standard of collection and curation of race and ethnicity data in healthcare (RAISE).

Health Equity Forum Podcast: Episode 13 - 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 Chardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at FDA.

In this episode, I will be speaking with Susan Winckler, Chief Executive Officer of the Reagan-Udall Foundation, or RUF, for the FDA, and Carla Rodriguez, RUF Director of Research. The Reagan-Udall Foundation is an independent organization created by Congress to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

I’m glad to welcome Susan and Carla for a discussion today about one of their newest projects, the Real-World Accelerator to Improve the Standard of collection and curation of race and ethnicity data in healthcare, also known as RAISE. The FDA Office of Minority Health and Health Equity is proud to have funded RAISE to help address the incomplete and inconsistent capture of information about race and ethnicity in real-world settings, which can limit full understanding of the distribution, safety, and effectiveness of FDA-regulated products that impact the health of the public.

Everyone, welcome to the Health Equity Forum Podcast and thank you so much for being our guests today.

RDML Araojo: so, Susan, why don’t we start with you. Many people are aware of the Reagan Udall Foundation, but for our listeners that may not be as familiar, can you tell us a little more about the Foundation and how RAISE came to be?

Susan Winckler: We are always happy to talk about the foundation. The Reagan-Udall Foundation is a non-profit, non-government organization that Congress created with the sole purpose of helping advance the mission of the FDA.

We’re a fairly young organization, at least compared to FDA, having been created in 2007, and I think we’re ‘hitting our stride’ in doing more to help FDA promote and protect the public health.

In 2020, for example, we launched a collaborative effort with Friends of Cancer Research to host the COVID-19 Evidence Accelerator—where we gathered the real-world data community to talk about what we were learning about COVID-19, first about the disease and then about the performance of diagnostic tests, vaccines, and therapeutics.

One of the many things we learned in that project, there were two things that stood out and those led to our RAISE collaboration—first, we learned that gathering a community routinely can help explore, and improve, our understanding and management of a topic. And on a much more tactical level, we learned that the presence of race and ethnicity data in real-world data sources could be much better—and in fact, must be much better for these sources to help us strengthen representation in clinical trials or just to generally understand product performance.

RDML Araojo: Thank you Susan. I think that is so important and Carla, I’ll turn to you now to ask you to talk more about the RAISE project. What are the challenges this project is trying to address as it relates to data regarding racial and ethnic minority populations?

Carla Rodriguez: Thank you Chardae, well more and more, Real World Data is being used to support clinical trials. For example by helping target populations in need of treatment for inclusion into clinical trials; it also helps us to define inclusion criteria and make clinical trials more patient centric; it's being used also for pharmacovigillence) and for Artificial Intelligence. But for these data to support those endeavors, the data needs to be complete and unbiased - which we know is not the case for race and ethnicity data.

We also understand that missing race and ethnicity data is not just because people don’t want to report it. There is certainly overarching distrust in the healthcare system that limits reporting—and we must take steps to bridge that gap; but there are also steps all along the data continuum of the healthcare ecosystem that are missed opportunities for collecting and managing race and ethnicity data – and this goes from training staff to ask patients about it; to having the appropriate race and ethnicity responses so that patients see themselves represented in those responses.

It also goes to ensuring that reported race and ethnicity is integrated or exchanged with other patient data, or even in the transfer of legacy systems. And all this requires the leadership of healthcare systems to acknowledge the gaps; the need to do better; and be aware of incentives to help support the investments to make improvements happen.

But we also know that there are many good solutions and incentives out there. The community needed a place to share this information.

So, RAISE is about creating a forum to share solutions that allow all of us to fill in the gaps along the data continuum of the healthcare ecosystem so that we can maximize collection and retention of race and ethnicity data every step along the way – from reporting, collection, curation, all the way to integration.

RDML Araojo: Thank you Carla. So, Susan, the RAISE workshops began earlier this year, and featured 11 different workshops. Can you explain how the community workshop series helps inform solutions to public health challenges?

Susan Winckler: So, in each of the workshops, we tackled a point along the continuum of data collection and data movement. We would look at that point, illustrate challenges and shared solutions; and discuss the pros and the cons of those solutions. We also aspired to engage a variety of voices in conversation—to better understand the patient and consumer voice in addition to the voice of the health care system, the payors, and the various data collectors, aggregators, and analyzers. They were really just engaging conversations.

RDML Araojo: Yeah, it is so important to hear all of those voices heard. Carla, now can you tell us about the main themes that emerged during the conversations?

Carla Rodriguez: Great question, thank you. One way we’ve presented our learnings is through the acronym, RISE UP. Where “R” is for respect for community autonomy, acknowledgement of structural inequity, and cultural humility which facilitate a better understanding of the importance of partnership between systems and people.

The “I” is for intentionality and transparency in collecting race and ethnicity data that can help address mistrust, misinterpretation, misclassification and missingness.

The “S” is for standards – we need standards that are safe, contextually relevant, and interoperable so that they can be implemented.

The “E” is for education, which is needed to increase awareness of incentives and resources for infrastructure, technical resources, and best practices.

The “U” is for understanding and alignment to address the dissonance between why race and ethnicity data are collected, how race and ethnicity questions are answered, and how those data are ultimately used. And how communities vs. health systems define health equity.

And finally, “P” is for payors who can collect race and ethnicity data too.

RDML Araojo: Carla, I also think our listeners would want to know if there were any barriers identified through these 11 workshops.

Carla Rodriguez: Yes, it was actually one of our aims to gather information on barriers to collecting, managing, and exchanging race and ethnicity data and to map those barriers to potential solutions, which we outlined in our workshop 10; and with the help of the audience that was gathered – we prioritized the barrier-solution pairs.

RDML Araojo: Another part of workshop 10 was the RAISE Roadmap. Carla, can you tell me a little bit about the roadmap you’re creating and how it will contribute to this project?

Carla Rodriguez: We plan on making this roadmap into a simple, graphic, like a “recipe” to share with a broad audience, not just in an academic journal! We are going to do further polling on this image; and talk about it in upcoming podcasts and at American Public Health Association meeting in October to answer questions and get more feedback on the adoption of this tool and really get people thinking about the steps we can take to fix the problem.

RDML Araojo: Thank you Carla. So, Susan, can you highlight some of most promising proposed solutions that emerged from the series of conversations?

Susan Winckler: Absolutely! An important solution, really, a strategy we heard in the RAISE workshops it that - no matter what you do – it is to include the patient and community perspective in your work. 

In terms of specifics, the RAISE community recognized that there continues to be a lack of transparency regarding how race and ethnicity data may be used. This may be particularly important for populations who may be at increased risk for bias or harm when reporting these data. We really must be specific and intentional about why we are collecting these data, how they may be used, and who may have access to the data for specific purposes.

Another solution is to develop messaging around those intentions—and then test those messages! Update the messages based on feedback and use them.

And finally, it’s important to adopt those refined messages into your communications.

This practice also lets researchers who may be using these data secondarily know whether it is appropriate to use race and ethnicity data given the reasons for and how those data were originally collected.

RDML Araojo: Susan, I also want to touch base on the Reagan Udall Foundation and your work overall in the health equity space. Why is it important for the foundation to continue to advance health equity?

Susan Winckler: In some ways, health equity is a excellent example of where the Foundation can help the FDA “do more”—strengthening health equity is important for FDA for a number of reasons, but some of the work is better done outside the Agency. If we don’t get a diverse, representative population engaged in clinical trials, that will affect labeling, coverage, and access to medical products—as well as patient acceptance. We know from work we did related to COVID-19 vaccines that individuals want to know that someone who looks like them, who lives like them, was involved in the research. When doctors and patients don’t see themselves represented in clinical trials, they are far less likely to prescribe or take that medication or use a medical device.

RDML Araojo: You’re exactly right Susan that is so important. And before we wrap up this episode up, Susan, can you let know our listeners know how they can find out more about the RAISE project, and how they can become involved?

Susan Winckler: It’s really easy, they can respond to an upcoming poll that we will be sending out to anyone who attended at least one of our workshops or registered to attend.

And if you plan on attending the American Public Health Association meeting, please come to our roundtable! We also have resources on our website, and we would be thrilled to share additional information.

RDML Araojo: That is great! Thank you so much Susan and Carla for being with us today and of course thank you both for your leadership on this project. We truly appreciate the opportunity to collaborate with you on this important work.

Susan Winckler: And the thanks go right back to you. We have so enjoyed working on this project and we look forward to continuing an extended collaboration

RDML Araojo: I 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 Twitter, @FDAHealthEquity. Remember, working together, we can create a world where Health Equity is a reality for all.


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