In the fourth installment of the McKinsey Action 9 Fireside Chat series, senior partner Lucy Pérez moderates a panel discussion on accelerating clinical trial diversity with Rear Admiral Richardae Araojo, Tesheia Johnson, Freda Lewis-Hall, and Leroy O. Perry Jr., with opening remarks by Marcella Nunez-Smith.
These speakers represent a wealth of knowledge and expertise across the healthcare ecosystem in advancing clinical trial diversity. Pérez is leader of McKinsey’s efforts to advance health equity. Araojo is former associate commissioner for Minority Health and director of the Office of Minority Health and Health Equity at the US Food and Drug Administration. Johnson is chief strategy officer at Yale Center for Clinical Investigation (YCCI) at Yale School of Medicine. Lewis-Hall is former executive vice president and chief medical officer of Pfizer and cochair of the Equitable Breakthroughs in Medicine Development (EQBMED) Advisory Committee. Perry is a pastor at St. Stephens AME Zion Church and Cultural Ambassador to the Yale Clinical Research program. Nunez-Smith is associate dean of Health Equity Research and C.N.H Long Professor of Internal Medicine, Public Health, and Management at Yale School of Medicine.
This transcript has been edited for clarity and length.
The criticality of diversity in clinical trials
Lucy Pérez: Good morning, everyone, and thank you for joining us for this conversation on accelerating clinical trial diversity. My name is Lucy Pérez and I‘m a senior partner with McKinsey, where I have the privilege of leading our firm’s efforts on health equity. I want to start by thanking all of our panelists for joining to discuss a topic that we are all very passionate about: how to accelerate clinical trial diversity in the US.
I want to offer a few remarks about the criticality of this topic, because we know that there is increased recognition about how important diverse representation is in clinical trials. It has been really inspiring to see the increase in the number of activities and initiatives that are aimed at improving clinical trial diversity.
Beyond the obvious benefit to ensure that medicines meet the needs of different populations, there are many reasons to support clinical trial diversity efforts to accelerate innovation, from enhancing scientific generalizability to enabling more efficient clinical trial operations. We are excited about this conversation because despite the crucial role that clinical trials play and the criticality of having diversity in representation, there are some very significant gaps, both in the reporting of racial, ethnic, and gender data and the representation of diverse groups in clinical trials.
Currently, less than 5 percent of clinical trial data reports racial and ethnic data. If we take a look at the FDA’s drug trials snapshots summary report from 2020,1 we can see that more gaps exist. For example, Black individuals make up 8 percent of clinical trial participants, despite representing 13 percent of the total US population. Similarly, Hispanic and Latino populations represent only 11 percent of participants, despite being 19 percent of the total US population.
These numbers underscore how crucial it is to get this right. We know that by having trials that reflect the diversity of the population, we can work toward enabling more equitable health outcomes for all. To kick off our conversation today, I’m delighted to turn to Marcella Nunez-Smith. She was unable to be with us live today, but she graciously recorded some remarks. Many of you know Dr. Nunez-Smith as a nationally recognized leader in health equity research.
Marcella Nunez-Smith: We have long recognized the need to ensure and prioritize representation in clinical trials, and COVID-19 drove this home. Thanks to multisector collaboration, we were able to make safe and effective vaccines available to the public relatively early in the pandemic. With the unprecedented goal to vaccinate a nation, we quickly had to understand the importance of trusted messengers and tailored messages to connect everyone with vaccines.
We have long recognized the need to ensure and prioritize representation in clinical trials, and COVID-19 drove this home.
In my roles working with the Biden–Harris administration on the federal strategy as senior adviser to the White House COVID-19 response and as chair of the presidential COVID-19 Health Equity Task Force, I was frequently asked if the COVID-19 vaccine trials included diverse representation. I was asked by individuals deliberating whether to get vaccinated themselves or to vaccinate their family members, and I was asked by community and faith leaders who deeply held the trust of communities too often actively harmed in the name of scientific discovery.
But when asked, I could answer yes, because of the push by advocates, scientists, policy makers, and others. In that moment, we did not let urgency compromise the imperative of clinical trial diversity. That made a difference. In September 2021, we achieved COVID-19 vaccination parity in the United States by race and ethnicity for those over age 18.
This historic accomplishment came about because as we were coleading and codesigning with communities and being responsive to community-generated expertise, the diverse representation reflected in the participants, scientists, and policy leaders advanced trustworthiness in the clinical research ecosystem. Job well done, and more work to do.
Here at Yale, specifically at the Yale Center for Clinical Investigation, we are still on our learning journey, and yet we celebrate our successes. We have transformed: we used to have low rates of clinical trial participation from those in our catchment who identify as Black and/or Hispanic or Latino. Now, the vast majority of our clinical trials demographically matches or exceeds that of our catchment in some trials here at Yale.
Over 90 percent of participants in the Cultural Ambassadors program identify as members of those underrepresented groups.2 Our experience here is consistent with the learnings of many others and demonstrates the necessity of community leadership, bringing all stakeholders—life sciences innovators, regulators, and clinical care providers—alongside community-generated expertise. Taking this way of working to scale is the inspiration for one of the initiatives you’ll hear more about today: Equitable Breakthroughs in Medicine Development, or EQBMED.
So don’t sit back. Lean in. I hope today’s knowledge exchange serves as a call to action for you to use your scope of influence to accelerate clinical trial diversity. I thank you for all you already do, and I thank you in advance for your next steps toward normalizing diverse participation.
Lucy Pérez: I want to echo Dr. Nunez-Smith’s remarks that I hope we leave this conversation energized and with additional tools and insights to work with our respective organizations to accelerate clinical trial diversity. We have a distinguished set of panelists for this conversation. Thank you for joining us today. I suggest that we start having each of you share a brief note of your roles in advancing clinical trial diversity. Let’s start with you, Rear Admiral.
Richardae Araojo: Thank you, Lucy. It’s truly a pleasure to be here. I lead the FDA Office of Minority Health and Health Equity. We have a dedicated mission to protect and promote the health of diverse populations through research, outreach, and communication that work toward addressing health disparities.
And, of course, advancing health equity is central to that mission and the mission of the FDA. We have long worked to advance diversity in clinical trials. The FDA is committed to increasing enrollment of underrepresented populations in clinical trials, and we have done a lot of work for many years to continue to advance this effort. I’m very excited to be here today to continue the conversation on ways that we can continue to reach that goal.
Lucy Pérez: Thank you, Rear Admiral. Ms. Johnson, if I may turn to you.
Tesheia Johnson: Thank you very much. My role at Yale has been in clinical research operations and related to how we efficiently and effectively run our large clinical enterprise across our catchment area, but we pivoted about 15 years ago to focus much more on the importance of diversity in our clinical trials.
When we were at a critical point, around 2 percent of our total population identifying as people of color participated in trials. That’s when I partnered with the wonderful Rev. Dr. Leroy Perry and others in the community, and we cofounded the Cultural Ambassadors for Clinical Research. That partnership has changed the face of how we think about and do research at Yale.
Now, we’re really focused on partnering with you and others on this call in EQBMED, which is Equitable Breakthroughs in Medicine Development, a grant that’s funded by PhRMA [Pharmaceutical Research and Manufacturers of America] that we’ll talk about a little bit more and hopefully in this session. EQBMED is really focused on how we can change this and bring trials closer to communities where people live, work, and pray.
Lucy Pérez: Thank you. I know we’re all excited to learn more about what enabled those terrific outcomes that Dr. Nunez-Smith was talking about. Dr. Lewis-Hall, if I may turn to you.
Freda Lewis-Hall: Thank you to everyone here, who I know works tirelessly in this space around health equity and in leveraging diversity in clinical trials as a way of informing ourselves and others on what to do so that every person can be their healthiest self. When I was a medical student at Howard University in Washington, DC, I sat in front of a patient. I had done extensive research on the disease she had and the medication and treatments that we were providing. I started quoting things: “Well, only about 5 percent of people experience this and 2 percent of people experience that.”
I was running all the numbers. After a while, she looked over at me, touched my hands sweetly, and said, “Baby, if any of it happens to me, it’s 100 percent.” So I started looking at the data that I had quoted to her and realized that she was not at all represented. She was over 80 years old; no one her age had been in these trials. She was a Black woman; no one who looked like her had been in these trials. It started me on this quest to see how we might be able to match the data that we have with the people we serve. I’m excited to have been able to do that in a clinical setting and a research setting at the National Institutes of Mental Health as a researcher and academic, and then for the past 30 years as a member of the pharmaceutical industry and community.
Lucy Pérez: Thank you, Dr. Lewis-Hall, and thank you for sharing that story, because I am sure this panel has many stories of how personal this becomes. Rev. Dr. Perry, if I may turn to you now.
Leroy Perry: Thank you. I’m so excited about being a part of this panel. I’ve been a cultural ambassador for the past 15 years for YCCI. One of the great American theologians, Paul Taylor, said, “But the situation demands that theology gives.” By that I mean, when we look at health disparities, we have to consider the situation: the social determinants of health, the disparities, and the voicelessness of those who have a voice.
That voice is not being heard. And one of the things that we’ve done in our program at YCCI is to give power to that voice. In so doing, we’ve been able to make a collaborative effort to change outcomes with health disparity, increase knowledge of health research, bridge the gap between medical development and community needs, and cultivate trust by dispelling myths and negative perceptions. I think we are a model for what can be done and probably what should be done going forward.
Including inclusion from the beginning
Lucy Pérez: Dr. Lewis-Hall, clearly there is lots of activity and effort to support accelerating clinical trial diversity. From your experience in different settings, what is the most effective, and what are the areas that you see as critical to have greater investment in?
Freda Lewis-Hall: There are some things that I think are exceptionally effective, and I’ll put it under one heading, which is to include inclusion from the beginning. What is the epidemiology of the disease? Who’s affected by the condition? Who was affected? How were they affected? Are they affected differentially? This is across all differences and similarities that we’re aware of. I think this is very important. Also, social determinants have been included in this epidemiology, and these differences—everything from your zip code, to your income, to the bus route that you take, and everything in between—have demonstrated that they affect outcomes. So including that, and knowing whom you’re looking to include, becomes important.
There are some things that I think are exceptionally effective, and I’ll put it under one heading, which is to include inclusion from the beginning. What is the epidemiology of the disease? Who’s affected by the condition? Who was affected? How were they affected? Are they affected differentially?
The second is around partnership: coleading and codesigning. These partnerships need to be from the beginning, not when you have your protocol down and your sites chosen and now you’re in and trying to figure out how to include. From the very beginning.
I was on a panel once and I was, again, very full of myself. I kept saying, “Yes, patient engagement is very important.” On the third patient engagement, this incredible advocate said, “Honey, we’ve been engaged for years. It’s time for us to get married.”
So I started thinking of it as this deep, long commitment that you’re making to communities. They do not want us to helicopter in, tell us what they need, and then helicopter back out again. This is a true partnership.
The third is that operational protocols have to include input from patients and caregivers. I had a patient tell me once that for a child with muscular dystrophy, a six-minute walk test didn’t work for them, and that what they really needed was to know if he could maintain his dexterity and speed on his iPad. Who would have thought of that? She did, because she understood his circumstances.
We have to pay attention to inclusion and exclusion criteria, operational things. “I’m not taking my mother for five MRIs, I’m so sorry. We cannot participate.” So how do you get that kind of feedback from the very beginning?
Last but not least is a sharing plan. People want to know, what is it that is going to happen as a result of my participation? How is this important to me, to the people that I love, to my community, and to the world? We need to figure out how we’re going to talk to them about what they generated.
There are many other things that I think are important and have proven to be beneficial in increasing diversity. What do we need? First, how to scale that. Right now, everything is being done trial by trial, site by site, company by company, institution by institution. How do we get this to scale? The second is workforce. We have an opportunity to pay more attention to who’s involved in clinical trials within-shop. And then finally, to double down on the technical involvement. This comes from someone who can’t fully use a videoconference call and find the mute button, but understanding the importance of technology to turbocharge us and the effort of diversity I think is really important. So lots of best practices and opportunities and successes, but lots of needs as well.
Lucy Pérez: Certainly. I love these themes: partnership, commitment, engagement. And I love this story of going beyond engagement to “get married,” the importance of getting that right, and bringing those insights from the folks who live this day-to-day.
FDA’s efforts in clinical trial diversity
Lucy Pérez: Rear Admiral, there’s a lot of activity coming from your office in support of diversity in clinical trials. Can you shed more light on some of those activities and the impact that you’re beginning to see from the FDA’s efforts?
Richardae Araojo: Sure. I talked earlier about how this is a long-standing commitment for FDA. We have over the years hosted public meetings, and we’ve developed resources and tools. We’ve issued multiple guidance documents that are supportive of clinical trial diversity. There’s a lot happening right now across the agency.
I want to highlight a couple of the initiatives that we have within the Office of Minority Health and Health Equity, and probably something that is very well known: we have our ongoing multimedia public education and outreach campaign. We know how important it is to raise awareness and provide education on the need for and the importance of diverse participation in clinical trials. With this campaign, we’re really working to overcome barriers. We want to be able to educate on key issues, combat myths, provide positive messaging about participation in clinical trials.
Our resources and materials feature diverse spokespersons who have participated in clinical trials. They share their story and highlight why they think it’s important for us to have diverse participation in clinical trials and clinical research overall. And through our campaign, we have different mechanisms so that we can really extend our reach. We have public service announcements, we’ve hosted public meetings, we have videos, we have podcast conversations, we have both print and digital-health-education materials in multiple languages.
We engage in social media outreach and, across all of these tools and resources, we have a dedicated website so that you can access them. We want our resources to be used. We want them to be helpful. We welcome feedback on additional resources that are needed. We also have had community organizations reach out, so we will print and ship materials free of charge to support you and your efforts to educate on clinical trial diversity.
Another area for us is making sure that we have broad engagement. So we really work to make sure that we’re engaging very broadly across many organizations, institutions, and patient engagement groups. We also have ongoing research. Dr. Lewis-Hall said this, and I think it’s so important: we want to be able to understand what are the barriers and challenges and how we can overcome those.
When we’ve had listening sessions with many different patients who talked about the clinical trials that they participated in, we hear about making sure that we have patients at the table when these protocols are being developed and also making sure that you are listening to patients. One of the barriers that we hear all the time, and this is something that we’ve known for years, is about transportation and making sure that you can reimburse for transportation. That’s the one thing that keeps coming up in listening sessions: that transportation is not provided. So where we know about barriers and ways to reduce them, such as transportation, we need to make sure that we are listening to patients and overcoming those barriers.
We also have campaigns for specific diseases and conditions. Collaborations are critical to this work. We collaborated with the HHS Office of Minority Health, and we have our Let’s Take Charge campaign focused on advancing diversity across lupus clinical research. So that has been an important education effort for our office as well.
I also want to highlight an initiative that we were really excited about launching. Not only was it the first chance our offices had to put out a funding opportunity, through our Enhance EQUITY Initiative, but we have been able to issue multiple funding opportunities that have allowed us to engage with diverse researchers and scientists across various organizations and academic institutions. That works toward achieving three aims: enhancing equity in clinical trials through our efforts to advance diversity in clinical trials, equitable data efforts—we want to be able to fund research that increases data available on diverse populations—and most important, equity of voices. We want to continue to understand diverse patient perspectives, preferences, unmet needs to inform the work that we’re doing.
But we also want to be able to make sure that we give a very public voice to our equity of voices. We have worked to develop our first Equity of Voices video series, where we feature diverse individuals. They share their story about living with HIV and their experience with antiretroviral treatment. Throughout all of our campaign efforts, we ensure that we have diverse individuals highlighting their experiences so that you can hear directly from them. And I think that’s so important and reminds us about the work that we do every day.
And there’s so much work happening across the agency right now. I know many of you are aware of the multiple guidelines that our agency has issued that are supportive of clinical trial diversity. At FDA, we are working to implement the various clinical trial diversity provisions from the 2022 Food and Drug Omnibus Reform Act, or FDORA legislation.
Lucy Pérez: Thank you so much, Rear Admiral. I really appreciate how you also highlight that this is not just about the representation of patients in trials. It’s also about data availability and the diversity of the healthcare workforce as we think about who are those investigators and others involved in clinical trials.
Collaborating to scale
Lucy Pérez: I’m going to go back to a word that Dr. Lewis-Hall mentioned: scalability. Ms. Johnson, you’ve launched numerous initiatives to advance clinical trial diversity, including the most recent partnership on Equitable Breakthroughs in Medicine Development. Can you tell us more about this program and what you think is differentiating in that path to enabling the scale that Dr. Lewis-Hall mentioned earlier?
Tesheia Johnson: It was an opportunity that we applied for as network partners, which includes the Yale School of Medicine, the Morehouse School of Medicine, the Research Centers in Minority Institutions (RCMI) Coordinating Center at Morehouse, or RCMI, and Vanderbilt. As a group, what we’re focused on is exactly what Dr. Lewis-Hall and Rear Admiral Araojo just referenced, that we need scalable solutions.
This project is essentially an 18-month pilot for us to look at how we could bring sites that have traditionally not been as engaged in clinical research across all levels of maturity. Some sites have very little clinical trial experience, some have more clinical trial experience, providing peer mentorship, providing additional resources, and providing operational enhancements to be able to move toward this clinical trial journey.
But what’s really important and at the heart of what we’re doing is doing this with community, with providers, and making sure that it’s not just the considerations of the pharmaceutical industries that are important to the clinical trials ecosystem, issues related to data quality and other things that are imperative for registration trials. But also considering, what are those side aspirations? What do they want to achieve? What does their community want to do in a focus area of diseases that they care about?
How do we make sure that all of these things are coming together in a single journey, that we can document everything, that we can test some of these tools that are being put out, making sure that they’re really fit for purpose in this space, and then support a larger planning effort to make sure that those sites can be sustainable beyond this funding period?
It’s a really important effort for us, and it’s early days. We’ve selected some of the initial sites and we have some partners on board, but we have a lot of early lessons about how to do this and how to be more intentional.
We’re also thrilled to be one of the fund recipients of Rear Admiral Araojo’s FDA funding announcements. So we have a lot of our own work here at Yale, partnered with Rev. Dr. Leroy Perry and the Cultural Ambassadors, partnered with our technology companies, our EHR [electronic health record] vendors. We’re focused on how we can approach technical solutions. How can we do it in a way to ensure that we’re including all voices, that we maximize the participation of all of the individuals in our catchment area, and how can we modify culturally, linguistically, stylistically, and by method, to make sure we’re reaching those populations and getting the information to all of our patients in a way that they want to receive it?
We’re really excited about all of our efforts around scalability and how we think about this activity. There’s a lot more to come, especially on our Equitable Breakthroughs, as we begin to work with the sites and our partners and our community partners there.
Engaging the community
Lucy Pérez: Rev. Dr. Perry, we’ve been hearing a lot about the Cultural Ambassadors program, which you’ve been leading for over 12 years, as one of the hallmarks of distinctiveness in enabling diverse representation in clinical trials. What are some of those critical elements of an effective, community-centric approach to clinical trial diversity? And maybe bring to life what is the impact you’re seeing that have on the community?
Leroy Perry: This subject is dear to my heart. When we started 15 years ago with Yale and its efforts to recruit minorities, one of our chief reasons for not wanting to participate was a lack of faith and also the historical perspective of how Blacks were used throughout history. Medicine in America was built on the backs of Black people who were experimented on and used for the good of the health agencies in this land. So we were hesitant. What really changed this was Tesheia Johnson saying, “We don’t have enough minorities in our catchment area. What can we do? What do you think is the problem? I know the problem is a lack of trust, because you guys are trusted messengers. How can you help us change this?”
We looked at the disparities within our community and saw what folks have come to realize after COVID-19: that we were highly affected by these outcomes. Black men dying at twice the rate of their counterparts for prostate cancer, women with four times the incidence of breast cancer, child morbidity —it was just off the charts. So we said, what can we do? We need to work together.
One of the things that we asked of Tesheia and the school was that we get some training, because you have to have knowledge. Part of the reason that our community is behind the eight ball is because that knowledge has not really been shared. They’ve been looking at the myths and the misconceptions, but they have not been able to harness all of the recent developments that are lifesaving. So by giving us this heads-up, we were able to go back into the community and empower them with some knowledge.
I remember when a doctor was recruiting for COVID-19 vaccines, and he said some minority people needed to be involved. I was working as the director of the fatherhood program at this time, and I tried to get some of the dads from the program. One of the fathers said to me, “Doc, don’t do it. Don’t get the shot. Wait until everybody else gets the shot and see how they make out.” I said to him, “Brother, if I wait, I may not be around when the results come out.” Because of our participation and our work, I think we had a 30 or 40 percent recruitment in that particular study here in New Haven.
We have to listen, and in listening, also learn, and in learning, also do. One of the things we learned during COVID is that you have to be innovative. We were not able to reach the youth population during COVID, and our ambassadors wondered why. We looked at the average age of our ambassadors and said, “We need some young ambassadors.” So we went along with Tesheia, who helped us to provide them with 40 hours of training.
We have to listen, and in listening, also learn, and in learning, also do. One of the things we learned during COVID is that you have to be innovative.
We learned from them some things about social media and messaging that were beyond us. With their help we were able to reach another population. So it has to be innovative: what the situation demands, we have to be able to give.
Likewise, during the pandemic, when our seniors got locked out from church, from going out to eat, we had a pilot program where we took seniors aged 65 to 85 for two weeks of training on how to get on to the internet, how to access their health charts and to sign up for different health discoveries, how to do telemedicine, and go on video calls and social media so they could still attend church. That’s what we talk about when we say bringing medicine to where people are.
I think institutions are looking for us to come to them. They say, “We’re doing this to help you. Don’t worry about compensation. We want your genes and your genetic studies, but because we’re going to help you.” Well, you didn’t help Henrietta Lacks and you didn’t help so many others in the field with your plutonium studies and all these different studies that were done in the past.
So we have to find a way. I think that’s what we’re doing, finding new ways every day. We got a radio station, and we have a lot of innovative programs that we use to help recruit and to bring people. That is what has made us a leader in the research that we’re doing.
Considerations for implementing diverse clinical trials
Lucy Pérez: We’ve received several questions. People love hearing what is working, but there’s a sense that there are probably things happening that are not effective. There is some mix of things that could be helpful to advance clinical trial diversity, but do not work so well. I wonder if one of you has a perspective on this question, things that perhaps we do too much of that are not clear that are meaningful in moving the needle?
Freda Lewis-Hall: Rev. Dr. Perry mentioned this and it’s very important: we do a lot of talking and not as much listening as we need to do. We go with our agenda. We go with all the information that we have instead of saying, what do you need? How can we work together? How can I help answer your questions and meet your needs, not just this transaction?
Listening is number one. Number two is, there are some policy issues that we may have an opportunity to address that would help us with better data collection, so that we have data to start with when we go into communities. But also important are things like, how do you provide transportation and how do you provide some compensation, and what do you do about childcare? How do you keep a site open so that someone who’s working during the day doesn’t have to take off to do their work? There are a lot of logistics we haven’t quite addressed yet, because we’re used to doing things the way that we do them.
As much as progress has been made, I do think that there is a good, long to-do list, some of them very practical—you just have to do it—and some of them are larger and more philosophical. I want to give one of my favorite examples of listening instead of assuming, regarding age differences. We were talking with a group of young potential participants in clinical trials and asking them in a focus group setting why they didn’t participate. They gave a lot of different reasons, but they didn’t quite mention mistrust directly. So the facilitator asked, “Does Tuskegee keep you from participating?” And one of the young participants said, “The movie?!”
So we brought our biases and we brought in our concept of what the barriers were. And instead, we could have just asked and allowed them to answer. I think listening would be at the top of my to-do list. We’ve got a ways to go in getting that deep insight that we need to partner properly.
Lucy Pérez: This question is about how to collect race and ethnic data given the insufficiency of categories that are standard from NIH [National Institutes of Health], for example, to be inclusive and appropriately descriptive. Are there any best practices that you could share? Also, how do you think about participants who may be resistant to provide this information due to fear of profiling and/or discrimination?
Richardae Araojo: This is an area that we know is critically important. We want to be able to effectively capture race and ethnicity data, especially in a standardized way. Federal agencies follow the Office of Management and Budget Standards for collecting and reporting race and ethnicity data.
We know these are not perfect. OMB [Office of Management and Budget] has announced and published their initial set of recommendations that they’re seeking public input on. We are looking forward to what will come. We have current guidance that highlights it. FDA, of course, follows the Office of Management and Budget Standards for collecting and reporting race and ethnicity data, and we will continue to follow to determine and see if OMB officially puts out new revisions to those standards.
Another area is making sure that we can explore how race and ethnicity data is being captured within healthcare settings, especially when we think about real-world data. We funded a project, called Raise, with the Reagan-Udall Foundation that specifically looked at this. The foundation website has a summary of the work that we did.
Essentially, this was a real-world accelerator to improve the standard of collection and curation of race and ethnicity data in healthcare settings. Through Raise, we had several virtual multistakeholder conversations, and the importance of this was for us to hear from experts in healthcare settings.
We wanted to explore, what are the challenges with collecting race and ethnicity data? What are some opportunities to improve the collection and integration of race and ethnicity data, even understanding there might be patients who want to opt out, and potentially providing that data? What are our healthcare settings doing and what are different organizations doing to continue to find mechanisms and ways to collect and integrate this data within their organization?
If you go to the Reagan-Udall Foundation website, you can see a summary of the conversations that we had. This is work that we are continuing. We know how important it is to understand health outcomes, especially those that will help to inform ways that we can reduce disparities. Data is critically important. We continue to work with many stakeholders to find ways to improve, making sure that that data is coming to us in a standardized way so that we can most effectively analyze the data. Tesheia, I know that Yale has done a lot of work, when we actually get to talking with patients about collecting and reporting this type of information.
Tesheia Johnson: We have done a lot of specific work in this area about the collection of this data and our electronic health record system. To Dr. Lewis-Hall’s point, it’s so important to have that technical aspect of what we’re doing to try to speed up this activity. So, first of all, we’ve been working with the EHR vendor to make sure that this is a question that patients themselves can answer.
It wasn’t perfect because it did start with those broad categories that we all needed to collect for FDA and NIH purposes because, as Rear Admiral Araojo mentioned, this is the current regulatory standard that we’re collecting under. But what we’ve done is expanded those, so patients have the option to tell us more about how they would like to be characterized. And on the back end of the systems, those are then mapped to the current categories that can be changed if the regulation changes.
Thinking about that from a broadscale implementation standpoint, our EHR vendor happens to be one of the largest in the US, but is worldwide, so that gives this ability to sort of standardize this approach in a very different way. But it puts the activity in the hands of the patient so that it’s not the person at the front desk trying to guess what box to check for race or ethnicity. That’s a really important step forward—a leap forward—in this space. Hopefully, with the broader conversations that we’re having, we’ll see that expanded.
Another thing I’d like to mention is how we are trying to transition the workforce. How do we make sure that we’re really addressing pipeline issues? How do we ensure that children from communities of color know that you can be something other than a doctor or a nurse? You could be an investigational pharmacist, you can be a research administrator, you can be an IRB [institutional review board] specialist, you can be a patient advocate dealing with billing issues.
We started a high school and early college internship and have had over 1,500 applicants. We’re doing all we can to try to maximize the exposure in those cases, but also to bring awareness and partnership through our opportunity with Equitable Breakthroughs to all of the practice sites.
How can they integrate their pharmacy students and others so that we’re spreading knowledge about clinical and translational research positions in a way that’s helpful? And at the same time, ensure that young people know that these opportunities are available and how to access them? Then they also need the tools so that their resumes are reflective of what they need to apply for their first job, whether it be in industry or academia or with a regulatory agency.
Lucy Pérez: Rev. Dr. Perry, did you want to add something?
Leroy Perry: Yes, I think being able to gather data about social determinants of health is very important. One of the things that we’ve done with the YCCI group working with Tesheia is figure out, how do we get this information from our community without being intrusive and breaking any HIPAA [Health Insurance Portability and Accountability Act] laws and all of that?
We decided to do what some Community Action Agencies do when our members come in and talk to us. What are some basic questions that we can ask them? Because not only do we help them to look into MyChart or Epic and get their blood pressure and temperature checked, but we can also connect them with 2-1-1 [for essential community services]. We can ask them questions like, have you fallen in the past year? Do you have access to food or clothing? Do you have any health challenges that we might be able to help you with?
The data alone that we could bring from our communities can help us with policy making and with some of the hurdles of bringing medicine to where people are and to their needs specifically. For instance, are you employed? Are you dealing with mental health issues? It doesn’t have to be your name specifically. And we have an app that allows users to search, and as navigators, we can help them. That’s one of the ways to move the vehicle from one place to another. The “All of Us” study that deals with precision medicine, that’s one of their aims.
Tesheia Johnson spoke to a crowd of 2,000 at the AME Zion convention in New Orleans, and people were signing up left and right. We had a health fair with 32 Yale researchers coming to the community. That’s unheard of. They came with their information so that individuals could get firsthand resources about research and certain studies that were going on.
We also had a kiosk where people could look up things related to mental health for those trying to get a screening. We learned recently that if you have been a smoker for more than ten years, over age 40, and you may need a screening, Medicaid and Medicare will pay for that. Most of the people in our community didn’t know that. How many lives had we missed saving because of the lack of knowledge? So we have to learn the heartbeat of our community and meet them where they are if we are going to change these health outcomes.
Lucy Pérez: You made a comment that ties back to something mentioned earlier about payments for clinical trial participation. Dr. Lewis-Hall, we often think that payments give us a means to lower financial barriers to participate in clinical trials. But for some low-income communities, it may be perceived as a risk or a threat to eligibility for social-welfare benefits that they rely on, and this may hinder participation in clinical trials. Any thoughts about how to navigate this issue?
Freda Lewis-Hall: Well, we have some policy solutions that need to be put in place. In some cases, for example, payments may be seen as inducements, which would be a negative thing, right? You’re paying people who need money to do things that you know may be dangerous to themselves. So figuring out how to characterize and ensure that this is support for participating in the clinical trial and not inducements in a negative way.
And then, how do you characterize that for people for whom there are implications for income and taxes, eligibility for certain aid and support? So there is probably a list of these challenges that need to be addressed, and I’ll pitch to others to see if they are aware of some of the activities that are going on in the policy space to address these things.
Leroy Perry: There are so many questions. Some people who sign up for certain studies are afraid that it will impact their insurance, and they will not be eligible for insurance if they sign up for a particular study that labels them or suggests that they have a particular condition. How do we guard that and keep that safe for them?
Regarding compensation, one of the problems we have is that folks who are poor are not worried about their taxes. Folks are worried about missing work. How do I get childcare when I come in? How do I get rides back and forth? These are basic things that they’re concerned about. When will payments be given? At the end of the study? Will I be given the drug that’s being tested, or will I be given the placebo? Or, once they know that this drug works, will they be given the drug or will they have to pay for it?
These are some major questions that anyone going into the study must ask sometimes. So what we do as Cultural Ambassadors is try to walk through that with the researchers first and then with those who might be thinking about recruitment for the program, so that everybody has a right to know the risks and issues with compensation, insurance, taxes. That’s of no little significance.
Richardae Araojo: I’ll add to what Rev. Dr. Perry mentioned: FDA does have guidance on payment and reimbursement to research subjects. But to highlight what Rev. Dr. Perry said that I think is so important is making sure we have patients at the table, the Cultural Ambassadors working directly at the table as those protocols and things are being developed, so that you can think through some of the potential barriers. What are the areas that we should consider so that you can most effectively build that particular protocol, that particular clinical trial, to make sure you’re reducing those burdens where you were able?
Tesheia Johnson: One of the other things Dr. Lewis-Hall mentioned is making sure that this is not seen as an inducement and ensuring that we’re addressing barriers. One of the things our ambassadors have been able to do is work directly with the IRB to explain how they see patient burden, address those issues in a way that would allow for regulatory approval, and not have those seen as inducements but rather a way to address equity and access. I think that’s another important point.
Looking forward
Lucy Pérez: I would love to do a quick round-robin. What is one reflection or suggestion about what it will take to get to scale, to get to those marriages that Dr. Lewis-Hall mentioned at the beginning? To get from engagement to marriage and achieve that goal of equitable representation and equitable health outcomes as a result?
Richardae Araojo: I wish I had a magic wand. I’m excited about the visibility, the momentum, and hoping that will continue. I know that there are some major efforts underway—we just heard about EQBMED—that are really trying to go from diversity in clinical trial efforts to sustainable, long-term solutions. So what I hope for is that we continue to go beyond talking about some of our efforts in clinical trial diversity and really get into what we are doing daily for sustainable practice.
Leroy Perry: I think bringing to the table stakeholders who will not just be there for today but who will be there for the long run is important. Those who are respected in our community, who realize there is a thin line between faith and science. That they will all come together and that, somehow, if we are willing to work with and educate and empower our community, we will definitely have better outcomes.
Tesheia Johnson: One of the things we have been working hard on is mission and vision alignment with investment. It’s so important to think about. If clinical trials diversity is really a part of something you truly believe in, then it should align with the investments that you’re making. We should try to make sure that those investments, that collective impact, all of these individual investments are going toward sustainable solutions. So that if this moment passes, which we hope it doesn’t, that there’s something left behind for the community leaders to point to and say they didn’t helicopter in for this effort: this was really an intentional moment with sustainable activity that’s going to move the needle and drive impact not only in research but in health.
Freda Lewis-Hall: If what we’re looking for is scalability and sustainability, I have a friend who always says to me about healthcare in general, “Why do we call it a healthcare system? Because we ain’t healthy, nobody cares, and it sure ain’t no system.” I disagree with the middle part, because I think a lot of people care. I think what we need is a clear pathway to a system in clinical trial diversity. So what does that system look like? Can it be all-hands-on-deck and I can say, this is a gap, can you fill it?
And what are the redundancies? Can we reduce that? Because there’s never enough time, toil, or money to get a job like this done if you’re repeating yourself and making the same mistakes. If I had to think of one thing, it would be the plan, putting the ecosystem together in a landscape and a system for scaling and sustaining.
Lucy Pérez: Thank you for that. This has been an incredible discussion. A huge thanks to our panelists for bringing their insights and experience. We look forward to continuing the conversation on this topic.
