Episode 19: How Can Clinical Trials Better Reflect Society’s Diversity?
Clinical trials are crucial to the development of new drugs, medical treatments, and therapeutics. The knowledge gained from these trials helps ensure that treatments are safe and effective. Trials are also sometimes the only way for patients to access the most cutting-edge therapies for a disease. However, wide swaths of the American population, including Black and Latino Americans who often face the greatest health challenges, are not adequately represented in the clinical trials and do not benefit equitably from this research.
On this episode, host Sara Frueh is joined by Gloria Coronado, an epidemiologist with the Kaiser Permanente Center for Health Research, and Jason Resendez, president of the National Alliance for Caregiving, to discuss the causes and consequences of this underrepresentation, and steps researchers and policymakers should take to remedy it.
- Read the May 2022 consensus report from the National Academies, Improving Representation in Clinical Trials and Research: Building Equity for Women and Underrepresented Groups.
Sara Frueh: Welcome to The Ongoing Transformation, a podcast from Issues in Science and Technology. Issues is a quarterly journal published by the National Academies of Sciences, Engineering, and Medicine and Arizona State University. From new cancer fighting drugs to the COVID-19 vaccines, clinical trials are essential to developing new medical treatments and ultimately improving people’s health, but large swaths of the US population, including Black and Latino Americans and other minority population groups, are not adequately represented in clinical research studies. What are the impacts of this underrepresentation, and what’s driving it? And what can we do to solve it?
I’m Sara Frueh, an editor for Issues, and I’m joined today by Gloria Coronado and Jason Resendez. Gloria is an epidemiologist at the Kaiser Permanente Center for Health Research, and Jason is the president and CEO of the National Alliance for Caregiving. They’ve both spent their careers creating solutions for health disparities and empowering marginalized communities, and both of them are among the authors of a May 2022 National Academies report titled Improving Representation in Clinical Trials and Research. Welcome, Gloria and Jason.
Gloria Coronado: Happy to be here.
Jason Resendez: Thanks for having me.
Frueh: For listeners who are relatively new to this issue, why does the lack of diversity in clinical trials matter? What are the consequences for people in underrepresented groups and for the country overall?
Resendez: I think it’s pretty simple. It’s about ensuring that everyone benefits equally from innovations in drug development and scientific research. It’s really important that we have adequate representation and inclusion in research because a lack of inclusion compromises generalizability of clinical research. What that means is that many groups underrepresented and excluded in clinical research can have distinct disease presentations or health circumstances that affect how they will respond to a drug or therapy.
So inclusion matters from an efficacy of drugs and therapies. And there are lots of examples of that. We highlight some of those examples in the report. For example, the blood thinner Warfarin is a good cautionary tale that we highlight. This is a blood thinner that was developed using study participants that were predominantly white with European ancestry, so when the drug and its dosing requirements were released, they were based on this subset of the population. And it turns out that Warfarin dose requirements vary across ethnic groups, even when adjusted for confounding factors, which suggests that genetic variation contributes to variability when it comes to dosing. And incorrect dosing can lead to increased risk of bleeding, hospitalization, even death. It’s a great example of using real world evidence why inclusion and representation of the individuals that could benefit from a drug be included from the research in the very beginning. The stakes are high. The stakes are life and death in a lot of instances.
Coronado: Yeah, I think I would just echo what Jason said. I think what our report showed is that there are some substantial financial costs to having underrepresentation of population subgroups and clinical trials and research. I think what’s also important is that I think there’s a high social cost, and that cost comes in having findings that don’t represent the population at large, findings that aren’t generalizable, which means that when certain patients go to their doctor, the doctor may say, “I don’t know. I don’t know if this drug is going to work on you or what the side effects might be for you or members of your community.”
I think that the other potential social cost is that it can undermine the scientific enterprise, and it can result in limited access to really those therapies and the benefits of science that we work so hard to create. It can stymie innovation, it can lead to research trials that don’t reach their goals for accrual. And I think both of those things can really undermine the scientific enterprise and undermine trust that patients might have in getting care from their physician.
Frueh: How severe is the underrepresentation for various racial and ethnic groups and for women?
Coronado: As part of the report, there’s a lot of data that was collected from NIH as well as FDA on the representation of participants in clinical trials and research. The representation of Latino patients in 2018, for example, was only 8.5% in the clinical trials that are funded by NIH, and yet the population percentage of Latinos is 18%. And so you can see that for that particular group, the underrepresentation is quite stark.
Resendez: And I think this also highlights, another important issue that we found in the development of the report is just how fragmented the data is around inclusion of underrepresented communities in research. Gloria highlighted some data from NIH. There’s some data from FDA. FDA has a snapshots initiative where it publishes data on approved drugs in terms of representation, but there’s a whole category of research funded by industry that is extremely fragmented.
This is 2022, and what we’re finding is that even when it comes to something as basic as understanding what the level of inclusion and exclusion is, that it’s really hard to do. I think that’s another important finding of the report is that we have a long way to go just when it comes to establishing baselines for inclusion and representation. And as Gloria highlighted what we see from an NIH perspective across the board is low representation.
One of the issues that I focus on in my career has been the impact of Alzheimer’s on communities of color. Alzheimer’s is a progressive brain disease. And when you look at federally funded research for Alzheimer’s, less than 10% are made up of Black and Latino individuals, even though Black and Latino Americans are two to one and a half times more likely to develop Alzheimer’s, respectively, than whites. There’s a high risk yet an underrepresentation of those groups within federally funded research.
And I emphasize federally funded for a reason. Those are tax dollars. Me, as a Latino American, those are my tax dollars going into advancing research for a disease that disproportionately impacts me and my family, yet we’re not being included in the research that could lead to lifesaving therapies that could disproportionately, and should disproportionately, benefit people like me, given the higher risk.
Frueh: Thank you for saying that. That’s an important point, Jason. These issues are societal, but they’re also personal, and lives are at stake. And it sounds like it’s also an example of tax dollars not doing what they should be doing in terms of working for the benefit of the whole population. How did these issues play out during the pandemic when it came to research on the vaccines and therapeutics? Were those trials more representative, or was it more of the same?
Coronado: Yeah, I would say that during the pandemic, I think that we were all made aware of the fact that certain populations were more highly burdened by COVID. And so Latino populations, African American populations had higher infection rates and were much more likely to be hospitalized because of a COVID infection. And yet in the beginning parts of a lot of the vaccine trials, we saw that recruitment was happening business-as-usual where there was an overrepresentation of not Hispanic whites in the vaccine trials. And I think what we saw for one of the first times in our history is that one of the pharmaceutical companies that was leading a trial, sponsoring a trial, actually suspended it in order to make sure that there was greater representation of the populations that had the greatest burden of COVID.
Resendez: And I would add on to that that I think COVID also demonstrated what we can do and what we can achieve when there’s greater visibility and greater accountability. Gloria gave an example of how things started, but they didn’t end up that way. There was more visibility around the lack of inclusion. There was a lot of national conversation given the disparities that we saw in COVID infection and mortality. And that resulted in changes being made by companies developing these drugs, including trials that were geared specifically towards individuals Black and Latino American.
Genentech, for example, had a trial specific to those communities when it came to their COVID drug. And I think that’s a result of that national conversation. It’s also a result of scrutiny. You saw policymakers really putting and dragging industry’s feet through the fire around issues of inclusion and diversity and trials for COVID. They were hearing Sarah Menendez send a letter to all the leading developers of COVID therapeutics asking about the steps that we’re taking to ensure equity in their trials. I think it’s a combination of that national visibility and awareness of the disparate impact of COVID, but also a combination of that awareness with accountability measures being put in place by policymakers.
Coronado: I think COVID showed us how quickly changes can happen if you have the right level of accountability and the right level of public will. And being from the research perspective, I absolutely saw that there was infrastructure that was created—really for the first time—around, hey, we need a registry. We need to figure out how to partner with community organizations so that we can do a better job of recruiting the Latino patients or recruiting the African American patients into these vaccine trials.
Frueh: I’m wondering if you can say a little bit more about that. It sounds like there were lessons that could be learned from the COVID experience about how to expand representation. And you mentioned a couple of specific things, but I’m wondering if you can say a little bit more about specific approaches that these companies used when pressed to have more representative trials. And could those be scaled and used more commonly going forward?
Coronado: Yeah, absolutely. I think one example is Kaiser Washington, that was one of the first sites to lead one of the vaccine trials. And I think they pretty quickly developed the registry of patients who were Latino, who were African American, and they worked with the community organizations to identify individuals who would be willing to participate in vaccine trials. And so I think really establishing that infrastructure for the vaccine trial was creating something that they can use in the future as well as other vaccines were to be tested or other types of research could take place at their site.
Resendez: Yeah, and I would add onto that. I think we also saw innovation in how sites were selected. I think a big issue that we see when it comes to inclusion of underrepresented communities are structural issues; where actual research sites are located.
When I think about Alzheimer’s, as an example, we know from research that Alzheimer’s Disease Research Centers, the marquee centers for federally funded research, are located in areas that are the most advantaged in terms of zip codes. There’s literally a physical access issue in terms of proximity in being able to make it to a research site.
And when we saw COVID, you saw a lot of emphasis on partnering with communities and also non-traditional research sites, engaging federally qualified health centers, for example, as part of research teams and doing that recruitment. I think that’s an example of how we need to expand our conceptualization of what research infrastructure looks like. That’s another big recommendation that we outline in the report that we saw work well in COVID and should continue to be adopted.
I think the same thing with setting goals. A lot of COVID studies set goals for the representation of communities that were at higher risk of COVID. Some of the things that they did were if you were in a site that had recruited its target for non-white Americans but had not done so for other communities, you stopped recruiting, you started turning away people who weren’t helping you achieve your goal. I think there are examples of goal setting and how you adjust study protocols to advance that goal setting that also can be adopted and continue to be utilized to drive equity.
Frueh: Jason, you mentioned that one of the things that makes a difference to participation in clinical trials is the location where participants need to go for appointments, which seems like it should be a very basic thing for researchers to consider when setting up trials, but it sounds like it doesn’t happen as often as it should. How much of a role do practical issues like that, like whether a person is able to find childcare or get time off work or have health insurance play in participation rates?
Resendez: I think they play a really big role in influencing who is able to participate. Just look at the current makeup of who are in clinical trials: predominantly well-educated individuals with high incomes who are getting recommended into a trial because of their provider recommending a trial or because they have the time to be advocates for themselves and look and research clinical research opportunities. I think there are a lot of structural inequities that contribute and serve as barriers to individuals participating in trial.
Site location is one. I think it’s a really important one that we’re able to fix. I’ve been in too many conversations where researchers have said, “Oh, that’s outside the purview of industry or us being able to fix that.” And it’s like, no, that literally is you’re selecting where you’re going to stand up a site. That is totally adjustable if you’re willing to invest in the long game of building infrastructure in communities.
And I think that’s something that we highlight in the report, that the research enterprise right now is very cyclical. The way the marketplace for research is very focused on three-year, five-year—these research cycles that really de-incentivize long term investments in building community partnerships and infrastructure for research. We have to keep that in mind and rethink what that looks like and highlighting incentives, for example, and different ways of funding research infrastructure. I think you see certain movement towards that with the work of PCORI and others really looking at funding community participatory-based research. And so I think that site selection and infrastructure is really critical.
But I also think awareness. Part of infrastructure and site selection means expanding what researchers look like. That word of mouth through your provider, especially if you’re going to something like a federally qualified health center or safety net provider, so that those providers are aware of research opportunities and are part of research teams, and so they can recommend to their patients trial opportunities.
We know from research that Black, Latino, Asian American, American Indian individuals are just as likely, if not more likely than non-Hispanic white Americans to express a willingness to participate in research if they’re asked, if they knew that it was a possibility and opportunity for them. And a lot of that comes down to those issues that you talked about: provider awareness, access to health insurance. I think it’s a lot of factors that influence whether or not someone is able to participate in research that too often are put under the rug and re-conceptualize research participation and put it all on the shoulders of the participant, and not recognizing the role that the ecosystem and the research enterprises has to play in addressing those structural barriers.
Coronado: I think that in the report, what we really demonstrated is that it’s a really multi-level issue. At the individual level, I think that individuals may not be aware that there’s a clinical trial that they could participate in. There could be differential awareness. And I think, as Jason mentioned, there certainly is differential invitation, and that can be because study materials aren’t translated into the language that people speak, that could be because the requirements or the criteria for inclusion in a study may be restrictive. It may require that the participants go in on a Wednesday at 10:00, but the patient can’t get time off work or needs childcare or has a number of other logistical challenges in meeting the study requirements. And then I think, as you mentioned earlier, there certainly are often some cost implications. And I know that the report focused on reducing the barriers to patients really getting that additional care that they might need as part of a research study.
Resendez: I think that Gloria brings up two really important points, one around language accessibility. How are we enabling folks that prefer to receive health information in a language other than English to access research? When we looked at clinicaltrials.gov, for example, which is the number one repository for federally funded research in this country, what we found was it’s 1) really difficult to navigate and get updated information, but 2) that there’s no way to search for trials by language, which I think is really unfortunate because we know that lots of individuals are non-English speakers or preferred to receive health information in a language other than English, yet we see the majority of trials in the Alzheimer’s community, for example, the majority of trials require participants to be English speakers. And if you don’t speak English, then you’re out of luck when it comes to accessing Alzheimer’s research, for the most part.
And it’s actually built into inclusion criteria. You’re excluded if you don’t meet that language requirement. However, there are many trials, and COVID was a good example, as one of the innovations of COVID where they were intentional about ensuring that non-English speakers were able to participate in research. That means study protocols were translated and developed, you had site coordinators and researchers that were able to communicate with folks in a language other than English. But that’s not the norm, that’s the exception. So you really have to look at language accessibility as part of this as well.
I think the other issue was all the connected issues around childcare, these issues of taking time from work, issues that are more common in low-income, working-class communities, especially in a country that doesn’t have a national paid family and medical leave policy. What are these issues that are not traditionally talked about when it comes to research participation, childcare, medical leave? These issues that a lot of researchers don’t really talk about or engage in are influencing the ability of individuals from minorized communities to beef up participants in this really important research.
Coronado: The other thing that we touched on just a little bit is really workforce and thinking about who are our scientists that are going out in the community? What does the workforce look like? Who is doing this recruitment? And is there a way that we can diversify the workforce so that we can be more successful at recruiting the communities that represent the US population and represent the proportion of individuals who are impacted by the disease that’s under study?
Frueh: The questions you raise about who scientists are makes me think about the issue of trust. And we can’t talk about underrepresented communities and clinical trials without also acknowledging the history of abuses suffered by those communities and research like the Tuskegee syphilis study. And I think many people assume that that history and distrust engendered by it plays a big role in keeping people from participating in research. But from your report, it sounds like trust is a really complex issue, that it’s important, but also that distrust isn’t the main thing keeping people away from clinical trials and that people will participate if they’re asked. I’m hoping you can talk a little bit about trust and unpack that complexity for us.
Resendez: Yeah, I think trust is complicated. I think it is absolutely a really important element when it comes to building equity within research. We have to focus on trust in addition to a number of other factors. But I think what happens, and at least in my experience, is that institutions and individual researchers often use trust as a crutch: “This is something that is beyond my ability to control; Tuskegee has created a barrier that’s going to be too hard for us to overcome.”
I’ve heard this from sites in working on research programs, and I think what it does is doesn’t recognize that trust is something you build. Every action you take is an opportunity to build or lose trust. It’s not just something that’s a historical reality, it’s something that is happening every day. And I think too often, researchers don’t conceptualize trust in that way, and institutions don’t conceptualize trust in that way.
And so I think one of the things we do in the report is put an emphasis on trustworthiness. What are institutions and researchers doing to actively build trust? Take, for example, study protocols. Really walking through your study protocol design and thinking about how this impacts the individual, I think, is an opportunity to build trust. Am I translating this into Spanish? Is my program accessible in other languages?—is another way of building trust. Gloria mentioned before, workforce, having folks that look like the participants you’re trying to recruit is another way, I think, of building trust. I think it’s important for the enterprise to re-conceptualize what it means to build trust and to recognize that trust and medical mistrust and research mistrust isn’t something that’s in the past, it’s something that’s continuing to happen today in the way that institutions are seen as exploiting communities. And recognizing being open about that, but not using it as a crutch but embracing ways of building trust, I think, is a really important way of moving forward and building equity in research.
Coronado: I think the last several years has really taught us the importance of trust in our public health system and what that can mean for our country and how it’s related to national security. I think with COVID, for example, we saw that there was an erosion of trust in the public health system, and that led to greater vaccine hesitancy, more difficulty in getting people to follow really basic precautions that would protect themselves as well as their neighbors and their communities from an infection with a virus that was killing people.
And so I think that from the perspective of how can we be trustworthy so that we can recruit for trials so that we have information that from these studies that represents the population at large so that that can also then build greater trust. And so I see it as a cycle of you need to start somewhere, and you can add to it at all these different points, but I think that we can’t underscore enough how important it is to work on trust, to really think about how we’re engaging communities and science.
And in some of the early work that I did in my career, I was focusing on pesticide exposure in an agricultural community in eastern Washington, very close to where I grew up. And my dad used to be a farmworker when he immigrated from Mexico. And so I grew up with a dad who had a fourth grade education, and so I recognize how important it would be for medical establishment to engage somebody with his level of education.
And so I also think that there’s a way to build trust that is about focusing on the issues that matter to the community. And so to do research on pesticides in an agricultural community was really powerful because this is work that mattered. And it was easy for us to then engage interns, engage high school students, college students at all levels to do work that really mattered to them and that would affect their community. And so that was also a way of building trust.
But I think it’s very cyclical because the more that we can get to the point where we can say, “Hey, did you know that this therapy is X times more effective in African Americans? Or did you know that American Indians also benefit equally from X, Y, or Z therapy?” That that’s also going to build trust when that patient goes to their doctor and actually gets data on how a given medication works in their community I think is a really powerful way that we can build trust. And that’s how this contributes to the larger cycle.
Resendez: I absolutely love the way that Gloria framed that. And I think it reminds us about a big part of the report that recognize is that there’s a power imbalance in the current way that we conduct research in this country where the power is all concentrated within institutions and within researchers and doesn’t recognize the vital importance of the role of the participant and the importance of re-centering research in communities and from the patient and caregiver perspective. And if we do that work, centering communities, the centering the patient and the caregiver and designing research to meet their priorities with them, I think a lot of these other things fall into place.
When you think about the example that Gloria gave with her father who had a fourth grade education, well, if you are building a research program and a research question that matters to someone like Gloria’s father, what are the other things you’re going to have to do to ensure that someone like that is included in research? You’re going to have to develop a consent form that is accessible to someone with a fourth grade education, that’s accessible to someone who speaks a language other than English, probably. And so really thinking about, well, what are the things that need to fall into place when I decide how it’s important to center communities? That is an example of how you build trust over time and how we can shift that balance of power to be more, I think, equal and mutually beneficial to communities.
Frueh: Thank you. That’s great. And I’d like to, along these lines, keep going and keep discussing solutions to the problem, one of which sounds like all of these steps to both address the practicalities of it and build trust and keep patients at the center of this experience and help them frame the research. But I guess it sounds like it’s a multilayered solution that lots of parts of the research ecosystem have to act in order for this problem to really be addressed. And I’d like to start at the ground level with researchers. And I’m going to ask you, Gloria, because you actually have served as a principal investigator or co-investigator on dozens of research trials. From a researcher’s perspective, how do you, practically speaking, approach this issue when you’re starting a research study? And what insights have you gotten from that experience?
Coronado: Yeah, really good question. One of the things I advocate for as a researcher is oftentimes in your research, you get an opportunity to do some piloting of your recruitment approach, your piloting of an intervention that you might be trying. And oftentimes what I see happen is that an organization or an institution might say, “Okay, well we’re going to start with the mainstream population, and then if we have time and money and inclination, at the end, we’ll figure out how we then tailor that to serve population subgroups.”
And what I encourage people to do is to turn that on its head because if you can start by thinking about any tailoring that you need to do to make sure that the patient with fourth grade education who doesn’t speak English as a first language or the African American patient who maybe lives 100 miles from the site where you’re recruiting, if you can think about those things up front, then your whole trial is going to be more successful at the end of the day.
And oftentimes, if you delay, delay, delay, then you often end up saying, “Well, we don’t have the resources, we don’t have the expertise, we don’t have the this or that or the other to actually accomplish that. Why don’t we just keep putting more water in the stream? Or just let’s just keep going with business as usual.” And so that’s the one piece of advice that I have is think about it up front and think about this as a priority not just for you and your institution, but for the greater social good. It’s not just that, “Hey, I need to succeed in my trial”—the decision to do this should be about how I’m contributing to the body of evidence, how, when that patient goes to their doctor, they can be told, “Yes, this therapy is going to work for your population or for patients like you.”
What we find in the work I do on colorectal cancer screening is that African American patients, when we look at tested messages, they love to hear, “Did you know that colorectal cancer is the second leading cause of cancer death in African Americans?” And so it’s really interesting how it’s so important to personalize those messages, and yet we lack so much of the data that would allow us to personalize those messages for the innovations and the new therapies that are coming out for a whole variety of diseases. That’s one aspect is to think about i upfront.
And then I think the other thing that is emphasized in the report is the importance of being really flexible in your approach. There’s a segment on remuneration and how we are compensating patients for the burden or the indirect cost of participating in a trial. And so for somebody who maybe is retired and lives really close to the center that’s conducting the research, they may not experience that much of a cost to participation, but that person who lives 60 miles away and works at a job that doesn’t have paid medical leave or has a bunch of other obligations, there is a greater financial burden for that particular patient. And so really thinking about what might be the burden for different population subgroups and what you might do to make your approach more flexible to really help those patients overcome the barriers that they face is also important.
Resendez: Yeah, and I would just add to that. I think Gloria’s done a great job of describing what we call designing for inclusion in the report. We need the research enterprise to embrace this concept of designing for inclusion. If you’re going to set a goal of greater representation in your study, making sure that from the very beginning you’re thinking about, “What are the steps that then I need to take to ensure success in reaching that representation?” If you’re doing that from the very beginning, as Gloria has mentioned, you’re going to make different decisions than if you thought about that at phase three in a trial when it comes to recruitment. You’re going to really think through your study protocol design, for example, and really think about, “OK, well how does this requirement that my study be an English only speaker affect my goal of inclusion? How does my requirement of the patient having a caregiver impact the success of adhering to my study protocol? How does my requirement of eight study visits in a month impact long-term success of my trial?”
There are, I think, a number of things that you’ll think about differently if you set that goal at the very beginning of the process and design for inclusion even before phase one. I think Gloria made a really good point earlier that connects to this about how we’re developing research that centers the interests and priorities of the community. Even before you’re thinking about recruitment, how have you incorporated the perspective of diverse participants and participants just generally in the development of research questions that matter to communities? If those questions are of interest to those communities and align with their needs, we cite in the report research that shows that you’re going to have greater chance and success at including in recruiting those communities over the term of your trial. I think there’s a number of things we need to do to center inclusion from the very beginning of the process, as Gloria has mentioned. I thought that was a really important recommendation from the report.
Frueh: It actually sounds like there’s a lot that individual researchers and institutions can do to improve representation. I’m wondering if we could also talk before we sign off about the policy level. What about federal agencies that fund or oversee this research? For NIH, FDA, improving diversity in clinical trials has been their priority for decades, but it hasn’t led to much progress. What should they be doing differently to support individual researchers and institutions in diversifying trials?
Resendez: I think that’s such an important point. I think you also highlight this idea that there’s a lot that researchers and institutions could do, but the reality is they’re not doing it. And I think that really underscores the importance of the ecosystem’s role and the role of accountability in driving some of the changes that we’re talking about. I think what we found is that there’s really a weak system of accountability. When it comes to even adhering to existing law, there’s very limited accountability for institutions and for researchers.
And I think, as we highlighted earlier in the discussion, how that level of accountability and scrutiny was one of the reasons why we saw COVID buck the trend when it comes to equity and inclusion of underrepresented communities in research. There’s a lot that agencies and the federal government and funders of research can be doing. I think one is reporting. We talked about just how fragmented the data is around inclusion and exclusion of groups across different therapeutic areas and more generally.
I think there should be, and we highlight ways that the federal government and industry can improve in terms of just giving us better data and even making existing data more accessible to patients and communities and to stakeholders, so that when we tell, for example, industry or a researcher, “Oh, you should set a goal of disease prevalence or integrate disease prevalence statistics across subgroups as a factor in setting recruitment goals,” that that data is easily accessible, is one example.
I think the other is looking at incentives. The report outlines some opportunities for introducing incentives to help particularly industry increase inclusion of underrepresented communities. Looking at not just sticks but also carrots including ways that [Centers for Medicare and Medicaid Services] CMS can incentivize inclusion of underrepresented communities, the way FDA looks at accelerated approval. How are we integrating equity into the accelerated approval process is another thing to explore. But I think overall, there just needs to be a greater focus on accountability and scrutiny and providing data to make better decisions and holding stakeholders accountable.
Coronado: I absolutely agree. And I think that, as we mentioned earlier, I think COVID really showed us, A) that accountability is a really important lever when it comes to equity in representation in clinical trials and research. And we also saw that I think change can happen quite quickly if there’s political will for that change to occur. And so what the report, I think, really nicely does is lay out all the different possible levers and what policies can be changed and what reporting and accountability can be put in place. I think, in addition to what Jason said about the need for greater reporting and potential carrots that we can create in terms of incentives, I think there’s also the possibility of policy that can really support the flexible remuneration of participants in clinical trials so that they can really get compensated for the extra transportation costs or the time away from work or what have you. And then also just policies at the institutional level around how you’re building your workforce and how you’re making sure that you have a diversified workforce and a diversified set of scientists who are thinking of the questions that matter to individuals from different communities and they’re thinking about ways that they can really build trust in communities so that we can have a very successful research enterprise that is built on greater public trust for the public health and the medical system as well.
Frueh: Thank you, Gloria. You made the point that change can happen quickly. And I want to wrap up with one question that gets at the likelihood and the potential for that. When you two think about fixing this issue, what timeframe do you think is possible? A year, three years, 20 years. If everybody takes the steps they should, how long will it take? And how likely do you think that is?
Coronado: Well, I think none of us have a crystal ball, and what I think of change is it can happen quickly, but I think that obviously typically the way change happens is it’s chipped away over time. But I think that in these moments when there is political will to change and there’s great acknowledgement and accountability and a desire to make sure that the vaccines that are being put through FDA as quickly as possible so that we can avert a public health crisis, that there’s great representation in who’s participating because we know that there’s differences in the burden. We know that certain communities are facing a higher death rate, higher hospitalization rate. And when you have a situation where there’s a short-term crisis, what you see is a lot of political will to make change happen.
And I think that what I get to see in the work I do is that that can have a ripple effect. And so the decisions that were made during COVID to change the infrastructure that might exist at some of the places where patients are being enrolled into these trials, that that infrastructure will be lasting and it will result in long-term changes where that infrastructure can be used for a variety of other purposes and conversations that are had because of COVID when trials are suspended because they don’t have sufficient representation, that those conversations can also play into other trials and the other recruitment decisions. And so that’s the type of change that I feel like I’m already seeing on the ground, but I think that it’s probably going to take another three to five years for some of the policy changes to be implemented in alignment with the recommendations of the report.
Resendez: I think it’s clear that we’re in a moment where change is possible. COVID set the stage for the art of the possible. And I hate talking about COVID that way. COVID was a public health crisis, a disaster that I’m sure many of us felt personally, I know that I did, but yet it’s changed the game and showed what we can do when the political will and accountability is there when it comes to advancing equity in research. That’s created a moment. It’s created a moment of not just here are the possible, but about visibility and a national dialogue around the importance of equity, not just from for the greater good perspective but also from a scientific and medical imperative perspective in a way that I don’t think has been to the level that it is today. And so I think there’s momentum that we haven’t seen before. I think we’re seeing the results of that momentum even impacting current decisions and issues.
I’ll give you an example of the Alzheimer’s drug Aduhelm, which came up for FDA approval, was approved. And then CMS made a very limited coverage decision for a number of reasons including because there wasn’t adequate representation of people of color in the underlying trials for a helm. And so I think there’s this not just visibility and awareness, but also actions being taken related to equity when it comes to drug approval and coverage that we haven’t seen before.
I think there’s momentum. I totally agree with Gloria that the only way we’ll continue to turn that momentum into action and to see improvement is if we sustain focus and accountability. I think there are some things that are moving us in that direction; this report, the National Academy’s taking this issue on helps move us in that direction. But I think it’s going to be at least a 5- to 10-year frame to actually see a lot of the, I think, bigger systemic issues.
We talk about low-hanging fruit opportunities, data reporting, but we also call out in the epilogue, for example, this more systemic shift that we need to see within the enterprise around recognizing the role that research and institutions and researchers play in contributing to inequities in this country, needing to reframe how research is conceptualized in order to really, truly embrace equity. That’s not something that can be legislated, that is a culture shift that needs to take place within the enterprise. I think that we have momentum around some of the short-term solutions, but we need to keep plugging away and not lose sight of some of these larger cultural shifts that need to happen in order to advance equity.
Frueh: Thank you so much, Jason and Gloria. I think that’s all the time we have for this episode. And I just want to thank you again for joining us, for sharing your insights with issues readers and listeners.
Resendez: Thanks for having me.
Coronado: Thank you.
Frueh: For a more in-depth look at this issue, read the consensus study report, Improving Representation in Clinical Trials and Research. A link can be found in our show notes. Subscribe to The Ongoing Transformation wherever you get your podcasts. You can email us at [email protected] with any comments or suggestions. And if you enjoy conversations like this one, go to issues.org where you can also subscribe to our print magazine. Thanks to our podcast producer Kimberly Quach and audio engineer Shannon Lynch. I’m Sarah Frueh, an editor for Issues. Thank you for joining us.