Overcoming Mistrust in Clinical Trials

Geralyn Warfield (00:20) 

Welcome to today’s episode where we are going to be taking a deep dive into the history of mistrust in clinical trials and strategies that we might be able to utilize to overcome that mistrust. Today I’m joined by Martinien Cho, who is a nurse practitioner and entrepreneur, and Dr. Bumi Ogungbe. Dr. Ogungbe, would you please introduce yourself to our audience? 

Bunmi Ogungbe (00:42) 

Absolutely, it’s such a delight to be here. My name is Bunmi Ogungbe I’m an Assistant Professor at Johns Hopkins University in the School of Nursing and the Bloomberg School of Public Health. And my background is in nursing and cardiovascular epidemiology. I do research primarily. A lot of my research focuses on lifestyle interventions to prevent and better manage cardiovascular disease. I’ve also worked on a lot of strategies, interventions, ways to really improve diversity and representation in clinical trials. 

Geralyn Warfield (01:16) 

Well, I’m definitely looking forward to our conversation. Marty, could you introduce yourself, please? 

Martinien (Marty) Cho (01:21) 

Absolutely. So I’m Martinien Cho I’m a nurse practitioner with a specialty in cardiology. I’m also the CEO and co-founder of Mechi, which is a software company building a mobile application that connects people to be more active to promote cardiovascular health and really looking at heart disease from a bird’s eye view, then a react, reactionary. And really saying, okay, we know that physical activity is important. We know that 30 minutes is important, but how do we really make people access that? And so that’s why we’re coming in. And so really delighted to be here and offer any words of advice or knowledge as far as research is concerned and diversity and really kind of leveling the playing field. 

Geralyn Warfield (02:08) 

Wonderful. Well, thank you so very much for being willing to be here on our episode today. And let’s go ahead and get our conversation started talking about the current state of representation. And Bunmi, would you be willing to start us off talking a little bit more about that topic? 

Bunmi Ogungbe (02:22) 

Absolutely. you know, something that immediately comes to mind is, where do we even begin? We’ve made some progress. I generally like to acknowledge that, but we still have a long way to go. And your question is, where are we? We may not be doing as good as we think we are in terms of representation in clinical trials, especially cardiovascular or cardiometabolic trials. 

Some numbers that my colleague and I have reported in publications based on our analysis are, for instance, black adults are only represented by 4%. So representation for black adults, and this is looking at cardiometabolic drug trials in particular that has been, that has really, okay, I’m going to start that again. This is looking at cardiovascular or cardiometabolic drug trials that have informed some of the new drugs that we’re beginning to see this day. So for black adults 4% , Hispanic adults and 11% of participants were Hispanic. So that’s one. Another key data that I should point out is that over the past 20 years, colleagues and I looked at cardiovascular studies. These are NIH-funded studies. And only one NIH-funded cardiovascular trial met its recruitment goal for black adults. Just saying again, we’ve made some progress, but we’re not doing so well. And there was a report from the National Academies of Science, Engineering and Medicine that came out I think last year. And some of the reports that they gave just in terms of how much this is costing us, they did say that if we are able to improve representation in clinical trials, we would be saving this country $60 billion just for cardiovascular disease alone. Now, think about oncology studies and other kinds of studies and just how much you will be saving if we’re ensuring that we have proper and adequate representation. 

Geralyn Warfield (04:27) 

So there’s a cost to not having representation and it’s not just financial. There are other costs to that. Marty, did you want to maybe just talk a little bit about what those other costs might be? 

Martinien (Marty) Cho (04:42) 

Yeah, certainly, you know, there’s the cost of just time commitment, right? Cost, institutional cost, where you’d rather have your nurses be at the bedside than be doing research. Because again, I don’t know the exact insights of this, but nurses to a hospital, for example, are viewed as like cost and not actually revenue generating providers. 

And so I can also understand from an organization’s perspective where they want to control their costs and actually use their nurses to provide services versus doing research that they don’t really truly know what the future is going to hold or the outcomes of that research is going to be and what’s the benefits going to be for them directly. At the end of the day, they’re just running a business. And then to touch on a point that Bunmi mentioned about, you know, and like just relating back to the question that you asked, like, how, what do we think the state of research is and diversity and representation? I actually think this is it is like, yeah, we’re making progress and one telltale sign is we are having this conversation now. Right? Like looking at us doing this podcast, right here, right now, I’m confident that when she released this, somebody else that looks like me sees this podcast or hears this podcast, they’re going to go, actually, yeah, wow maybe I can, you know, start to trust when a nurse or a nurse practitioner or physician assistant or even a doctor that comes now and tries to recruit me to do research. 

Geralyn Warfield (06:21) 

I that’s great. And I think one of the other considerations for what PCNA is interested in is definitely increasing the diversity in clinical trials. But we’re also interested in increasing the diversity of individuals who are running those trials, who are acting as principal investigators, who are acting like care coordinators. For these studies that are happening across the country and across the globe, I think sometimes nurses don’t see themselves maybe in that role. And so sometimes that’s a barrier in terms of making sure that we have adequate diversity in terms of those people that are involved and engaged in the actual doing of the research. So, Bunmi, I’m curious what this cost is, not just in terms of financial gain, but what would it cost in terms of if we were able to eliminate disparities for some of these populations, what would that look like in terms of lives saved, for example, or a similar type of statistic? 

Bunmi Ogungbe (07:17) 

Excellent question. Now you’re really, I’m thinking of a research question. That’s really a research question. Just being able to analyze the quality of life, the quality and the life saved. There may be some publications on that, but really it’s going to be substantial. And the reason is a simple analogy is the more people we are able to recruit, the more diverse the sample is, it’s likely that those people would benefit more from the devices, from the drugs, from the new model of care that this clinical trial is providing effectiveness or efficacy data on. So it’s really literally saving lives.  

Increasing diversity in trials is saving a lot of people a lot of lives. I would… This is something that I think is a little personal to this person, and I’m sure she’s okay with me mentioning her name, Dr. Bibbins-Domingo, who is the JAMA, Journal of American Medical Association editor-in-chief. She did share in one, in I think the introduction or the prologue to the NASEM report I mentioned earlier, the National Academics of Science, Engineering, and Math’s report on this topic. And something she did share was the story of her father, as an example, who passed from prostate cancer and she did share how she recognized and it really home for her that when a father was, when they were looking for treatment and trying to see trials they could join. For some reason and for various reasons that we know and reasons that we did not know, there was just that very high barrier. Eventually they did, obviously, she didn’t share some of the details, but just saying that there are people who are black, there are people who are brown who may not even know that there are ongoing trials that may be effective or that could help whatever this condition to, maybe they may have a diagnosis they may have. So there is that problem of awareness. There’s the problem of by the time people are made aware of some of these trials, the progression is you know, there’s very little progression is long gone.  

So really to answer your question would literally be saving lives, a lot of lives, we would be improving the quality of life, we would be improving the quality of care that we give, and would be reducing costs, costs to the health system, to people, to families, if we work hard, if we do the hard work now of increasing representation in trials. 

Geralyn Warfield (09:58) 

So let’s really think about historically why many people don’t appreciate the value of a clinical trial and don’t see themselves involved or engaged in a clinical trial. And in many ways, it’s a visceral reaction to historical wrongs that have occurred. 

And Bumi, I’m wondering if you could just cover some of that historical mistrust that we have nurtured over time with some of these populations. 

Bunmi Ogungbe (10:25) 

Yes, I can, and I could mention some well-known ones and some lesser-known instances. Unfortunately, we continue to, well, we know of historical events that contribute to mistrust in biomedical research. There are ongoing ones as well that we really should be questioning and continue to bring forth to light. So people, some people may be familiar with the Tuskegee syphilis study 1932 to 1972, which is a long time, I should say. And something that maybe a few people may not be aware of is that nurses were actually involved in that particular study and there are several reports in several books and I think even movies have been made based on that people somehow trusted the nurse who was going to work with men.  

I should probably take a step back. I’m operating under the assumption that people actually know what the Tuskegee syphilis study was. So I should probably say that this was a study which, like I said, happened between 1932 to 1972. And a lot of black men in Tuskegee, Alabama, who had syphilis, were being recruited into this observational study. There was treatment for syphilis at the time or there was some form of management, but they were basically denied that. And it’s a sort of like a natural history experiment of some sort. They wanted to see what the outcomes were. And so these men were basically denied treatment for years and years and years. And actually, I think in some of the reports, it was called bad blood. So the men thought they had bad blood. That’s why they had this condition that no one at the time it seemed like there was no treatment for.  

And so the point about nurses, was sadly, there were some people who were part of that trial, there were nurses who the men trusted and I think there are debates on whether the nurses actually knew what was going on or not. But all of that to say that that is one common instance, historical event that people would cite and yeah, it did happen. It did happen. Even after treatment was available, they were not provided to them. And so people just did not trust researchers, did not trust biomedical research.  

There is the Guatemala STD or STI experiments between 1946 and 1948. This was almost, this was on an international scope of just unethical research. And this was discovered really late. And I think the US government had to formally apologize for that. 

There’s the Puerto Rico birth control trials. And for that, I think to an extent, there is still ongoing investigation in that. And there were women who reported being sterilized without their knowledge. So those are examples. There are other examples like the prison studies that have been conducted. And that’s why in research these days, we have people who are termed vulnerable populations. And there’s extra layer of safety for people who may be institutionalized, who may be being recruited into clinical trials and they are in vulnerable states of their life at the time. So these are some instances, but they are also ongoing ones. They are ongoing ones of people sometimes talking about cohesion or that the study was described to them in a way that doesn’t quite fit the study activities that they were eventually asked to do. So these are some reasons. There’s Henrietta Lacks. 

So these are some reasons or some instances, historical events that have happened which contribute to mistrust in trials and research. 

Geralyn Warfield (14:19) 

I really appreciate you taking us on a historical perspective of some of the reasons that people have mistrust around trials. Marty, I know that you have a different perspective about clinical trials and I’d love for you to share that with us if you would please. 

Martinien (Marty) Cho (14:33) 

Yeah, absolutely. And I think Bunmi just touched very lightly on the her, like Henrietta Lacks cells, which to me, that’s something that when I, when I watched the documentary and that kind of triggered me to go down the rabbit hole and actually read the story and the history behind it. And I think from a researcher, even a research participant’s perspective, educating ourselves, I would say that’s something that is really shaping the way diversity in research is moving and growing. But there’s also definitely like, again, Bunmi said earlier, we haven’t done enough. We definitely haven’t gone far enough, that we still have a long way to go. And this is even as early as 2020 or 2021 when I had volunteered to basically be a part of an early study during the COVID pandemic. And in my mind, you know, this is a reputable organization. I’m not gonna disclose the name here for privacy and lawsuits reasons, but this is a reputable organization. I was a frontline employee at the time. We were the first ones that were getting the first vaccines that were coming. We needed to stay out and working. And there was a study being done by the institution and obviously they reached out to me and say, hey, know, we’re looking for people of color to really help and we know we have faced challenges to try and record… I’m like, absolutely, sign me up. Like, I understand this. I know how difficult it can be as a researcher. However, what I ask in return is that, you know, you just kind of keep me updated. Right? As you can imagine, this is in middle of the pandemic. People were living in the land of the unknown. Nobody really understands the virus. Nobody really knows what’s going on. So to me, it was just to have some sense of like grounding in research that’s being actively developed. So I felt encouraged to go back to work and take care of patients. So when patients had that look of panic, I could somehow give them the hope that there was research that was being done. 

Unfortunately that was not the case. And of course I’ve come to learn that there’s other logistical challenges that go into research, but at the time I did not know that. Right. At the time I, and this is, I’m someone that’s educated. I was plugged into the institution both as an employee and wanted to volunteer for research. And I could have easily just fallen, I fell to the cracks and I’m not going to lie that definitely challenged my trust and like well, if you’re going to try and recruit me again next time for research, why should I do it? You know what I mean? 

Geralyn Warfield (17:29) 

I really appreciate you sharing that more recent perspective, Marty. That was really important for us to hear. And, Bunmi, I think you’ve been really supportive of that through our conversation right now, too, that this is not just something that happened in the distant past. This is something that we need to address even now. And we have an obligation to our patients. We have an obligation to research, to make sure that we are dotting all the I’s and crossing all the T’s, as they say, to make sure that we’re doing things in an ethical way to make sure that we are as inclusive as possible so that the science stands on its own, whatever those results are. And I know that that can be a difficulty for somebody who is perhaps in an academic setting and needs to do some publication. And of course, we all want to be successful. We all want these things to go well. We want the outcomes to be as delightful as we want them to at the outset. But I think that honesty, both from the start to the finish. From the start in terms of here’s what our expectations are to the end of we met our endpoints, we didn’t meet our endpoints, what can we learn from that? I think that’s a longitudinal thing that we all face each and every day. So I appreciate you sharing that personal perspective. Can’t get those words out today. Bunmi, I know that you have some resources that people might turn towards. Would you be willing to share those for us? 

Bunmi Ogungbe (18:51) 

Yes, absolutely. I’ll start by saying that we’ve moved, and this is relevant to healthcare delivery as well, we’ve moved more towards patient-centered care, really ensuring that patients are centered in the care that we provide. Similarly for clinical trials and for research, we are more and more talking and advocating and ensuring that there is a shared understanding that participants should be centered, it is really participants in community-centered research. It depends on the kind of research, some in the community, some are just really in-patients or clinical, but even for those, it should be centered around the participants. So I do want to say that and say that a lot of the resources or tools that I can share are some tools that take that into consideration. That truly understand and truly outline how that can be done in terms of early engagement and sharing before we even submit the proposal for funding, right? How are we engaging people who would, could participate?  

So one of the trials that our study, that I’m leading through the American Heart Association, it’s a food is medicine initiative, food is medicine for hypertension, it’s called THRIVE, but what we did in the beginning was human centered design, human centered approach. We actually just held a series of meetings with people who could participate, people who looked exactly like the participants we were trying to recruit. And we gave them, this is what we’re doing, this is what we’re trying to do. Can you co-design this intervention with us? Can you tell us what would work, what would not work, what would you like to see? So that’s one resource I would say I will point out to. And we can, if it’s possible, to share links. 

But using things like Human-Centered Design approach, which may not be part of originally be within the research enterprise, but these are theories and approaches that have been developed and that could really facilitate that community engagement, so participants engagement process. There is the NASEM reports that I have been mentioning in the National Academies of Science, Engineering and Maths. They have this really nice report that I like because it is thoughtfully written, in my opinion. And there are lots of strategies and what can be done even for people who are not primarily researchers. I encourage people to read that report. The NIH has some guidance in the FDA as well and some of these have been updated recently and these are guidance to researchers for instance and exactly how to set a target for recruiting people from specific backgrounds into their research ensuring that the are careful and thoughtful in that process. But also for people who are potential participants, people who are just interested in how research is conducted, I refer them to some of this guidance. And I can get the specific name if people just want to Google it. I should be able to find that before the end of this podcast. So there’s the one from NIH, there’s a recent one from the FDA. These are resources in terms of things that people can read, that is being put forward to ensure that we continue to move this conversation forward. But not just that, but that we have actionable strategies that people can incorporate into their work. 

Geralyn Warfield (22:26) 

And I just want to make sure that our audience knows to look in the show notes for this particular episode. We’ll have those links available so you can find them just in case the Googling doesn’t work for you or maybe you’re in the car or wherever. We’ll make sure we have those available. 

Martinien (Marty) Cho (22:39) 

If I may also just chime in as far as resources are concerned, think certainly want to highlight tools to people that are actually going to be performing their research themselves. And again, want to highlight that, yeah, we want more nurses to be involved. Let’s actually use nurses. Nurses are a tremendous resource. Specifically, culturally competent nurses. I know that was definitely a class that we took in nursing school because basically from what I was trained is nurses are the ones that are plugged in into the community. We’re the ones that are seeing the patients day in and day out. It’s much easier for them to trust us. And so naturally you want to deploy someone that is culturally competent to go and perform this research for us. 

And certainly patient advocacy and listening to patients. I think that goes without saying that nurses are built to do that. It’s literally in their DNA. And then suddenly fostering long-term relationships. So don’t recruit a nurse that has just, maybe is doing a home visit or has started seeing a patient for a home visit and will try and recruit that patient for research. Well, maybe not the first week that she’s seeing that patient, or he is seeing that patient, or they are seeing that patient, right? We maybe go after the nurse that has a patient pool that they’ve been seeing consistently for like three or four months. Someone that’s already established a relationship. I think those are all really strategies or tools that we can actually leverage when we are thinking about nurses and research. 

Bunmi Ogungbe (24:26) 

You know, that actually brings to mind for me, I think, and I know for instance, PCNA has the leadership series and recently there was one on this topic of diversity in clinical trials in particular. I wonder if in addition to that part of the resources that we could maybe create and then the people may be able to access is some of those certification programs, in-service training so that people understand research. Marty, to your point, I think in a way it breaks my heart. I do wish that a lot more nurses are involved, are trialists, are leading research and also part of research teams, but also even have the fundamental understanding of what research is. To the example you gave, ensuring that there is that trust, there is that therapeutics that has been established first before talking to people about joining a particular trial. So I know there are, and this could be some of the links that will be provided as well. There are some free classes that people can take, like online courses that people can take on just introduction, introduction to research. What is an institutional review board? What did they do? What is a consent form? How do you approach people about research? What terms are cohesive? Which ones are not, which how do we message research?  

So I will give an example, for instance, as a PI, I can’t put a message about a research without putting the word research study in it, regardless. And this is something that is, it’s such an interesting tussle between our community partners and IRB. IRB insists that if it’s a Facebook post, a TikTok, whatever it is, it needs to have the word research in it, because it’s part of transparency. People don’t feel like it’s just a marketing survey, but it’s actual research, right? And people, community partners, they go, people will, that’s a signal. It’s like a mistrust signal. People don’t want to see the word research in there. So if you, how about, program, right? Program is a little bit more ambiguous. People would not think too much to it. So just as an example of, obviously our team will come back and say yes, we understand and we really hear you. We can’t really do that because we have this oversight board, the IRB. So these are things that, for instance, nurses may be able to access, if we come up with that and learn some of this, just the inner workings of trials. 

Geralyn Warfield (27:06) 

We have been covering a lot of complex topics when it comes to diversity in clinical trials. We are going to take a quick break and we will be right back. 

Geralyn Warfield  Welcome back to our audience and to our guests, Martinien Cho and Dr. Bunmi Ogungbe. We have covered a lot of ground already talking about that diversity and some mistrust and some of the barriers that we have. But I’d like for us to pivot just a little bit and talk about some more potential solutions for increasing involvement in clinical trials and how we might go about that. If we think particularly about patients in rural areas, which is not necessarily  

a group of people that researchers are focused on for a variety of reasons. Let’s talk about what kind of barriers there are there and how we might overcome those. Bunmi, do you have some ideas for us? 

Bunmi Ogungbe (27:55) 

Thank you very much. That’s such an excellent question. And I think in order for us to talk about solutions or strategies, we really need to talk about the barriers instead of like being able to define a solution, a problem so we can prefer solutions to it. So under-representation in clinical trials seem to be a complex problem to some people, to some other people, maybe it’s a little bit more of a simple problem in the sense that as long as we’re able to identify those various levels of barriers, we can prefer simple solutions to each of them. I think of this as like multi-level, because we have barriers at different places. We started to talk about hidden costs earlier, and I would say in addition to some of the barriers associated with hidden costs that Marty had mentioned, there are other things that have to do with hidden costs to patients or participants. 

For instance, sometimes in research studies, people are asked to come in during the week for study visits. Now, people have jobs, and as we know, people are different socioeconomic levels in this country, and that could mean people are working multiple jobs and they barely have time to actually come in for study visits. Thinking about things like that, thinking about not having childcare, not even having transportation to go to the medical centers. So that’s a possible barrier and perhaps a solution could be that studies being a bit more flexible. There are some studies that are beginning to incorporate things like providing onsite childcare or as the pandemic taught us, a lot of things can be virtual. Some things can actually be online. There are some really nice  

ideas which we’re beginning to use in some of my own research. It’s like sample collection can be done at home. There are some at home sample collection kits. We just send people a kit and say, can you please put the sample and teach people how to use it and people send it back and that eliminates a couple hours of actually coming in for study visits.  

Another one, especially that impacts people who live in rural communities are just access, access to academic research centers. The way the research enterprise is currently set up, which I think really needs to be evaluated, reimagined. need to think differently about how the conduct of research through specific academic centers. A lot of academic centers are situated in urban areas. A lot of people who live in rural areas have to, even when people need advanced or tertiary level care, they have to travel to places where the academic centers exist. And those academic centers are also places where research and clinical trials tend to happen. So ensuring that there is that opportunity. Would it mean having a network or network of hospitals and academic centers that cover specific research rural areas? Is it having satellite centers that can easily be done? Could it be solutions like mobile vans? There are mobile vans that we now know can provide a wide range of care, comprehensive primary care. And I do know some colleagues who are doing this kind of work, like the mobile van has been equipped to provide primary care, but also research related or research grid care or research study activities, study visits, research visits.  

So that’s another example, if you want me to keep going, other things are just in terms of awareness and knowledge barriers, right? There are specific ways, like I shared earlier, that research is communicated or marketed. That may not actually be, you know, it may not actually be done in ways that people can engage.  

I’ll tell a simple story. I was talking to my hairstylist, actually this past week. (32:04) 

We have this idea that we are testing out and I can talk about that later, but I was asking her what would make research more, what would make you want to, why would you want to participate in research if you’re considering? And she said, well first of all I don’t think I will and then she goes, the reason is it’s not interesting to me whenever someone comes to talk to me about heart health or heart health research I’m like really? It’s just so boring. I don’t want to listen to it and oftentimes I’m like it’s okay.. Well, maybe in a couple years or maybe in 10 years or so, I’ll worry about that. And then I followed up and was like, okay, if we were to make this a bit more engaging, do you have ideas? She said, it has to be fun. It has to be a lot of fun was what she kept saying. So these are feedback that we could probably incorporate. We have social media, we have TikTok. How about we get on those platforms and actually engage people and speak the non-scientific jargon, right? Actually speak language, everyday language, that would make sense to people.  

I work with the Institute of Clinical Research at Hopkins. I do some work with them and they have a recruitment innovation unit. And I cannot tell you how many studies come to us to consult when they’re having some issues with recruitment. And the first thing we ask is where is the flyer? And nine times out of 10, it’s like just this heavy text, just really badly constructed flyer. And I’m like, if I was going to a store and someone hands me this flyer… I don’t want to look at it. So do we need to consult with marketing experts? The people who this is all they do. They’ve started, they know exactly the exact fonts, the photos, the whatever messaging would work and be engaging and be fun. Do we need to bring them to be part of research enterprise? Should they be helping us craft this research to increase awareness and to ensure that people who should know, and people who live in rural areas who should know about research increasingly know about it. Those are some barriers and some solutions. I’ve got more, but we can talk about them later. 

Martinien (Marty) Cho (34:08) 

I can certainly chime in a few that I have to just, you know, listening to Bumi I’m like, yes, I agree with that. Yes, I agree with that. I know from just a personal experience of launching our company, the first thing and this is going out of the, you know, research design or, you know, innovation design where I had a hypothesis and I needed to go out and test a hypothesis.  

My hypothesis was do people even engage in moderate intensity activities? And do they even know what activities qualify as those? And one of the questions that we came up on our survey was, you know, active hobbies. Most people probably went to high school, they played baseball, they played soccer, they played… What’s keeping them from doing those things now? So the initial survey questions we’re going to give out had like 15 questions on them. And I presented it to my team and they all laughed. They were like… no one is going to be reading 15 questions. So we had to literally bring it down to a point where we ended up with six questions. And with the six questions, no one’s going to click an email to open it and go read it. So we had to be even more innovative and say, okay, let’s make it in a nice flyer, put a QR code on there. So basically all I did was went to like parks where people played soccer went to parks with people played tennis. And when they walked by, I’m like, hey, I’m doing a study about blah, blah, blah. Do you mind just participating? Literally to the point, like I could not make it any easier than this for you to participate. 

But I will say most people were like, yeah, actually, yeah. Because it was easy, they could scan the QR code, they scanned and they literally were filling it and already on their phones anyway. So they just fill it with five, six questions, boom, submitted. The first pass through when we did doing like handout and sending a link, response rate was probably like 25%. When you went to the QR code method, response was like 70%. So I think that certainly leveraged one, using technology to our advantage, right? Technology is here to stay, it’s not going anywhere.  

One thing I would like to highlight though is definitely the economic status and how that directly links to research participation. And I think Bunmi already kind of highlight on this is like, yo, you could have a single dad or single mom who works two jobs. Okay. And she has to take two buses to get to a place. Yes. Granted, she gets sick, she comes into the hospital and we’re like, my God, you have a rare disease. Let’s recruit you for a study. And that moment, she’s going to sign up, right? Because she’s probably panicking and she’s like, you know what, they’ll figure it out. 

But then the moment she leaves and now you have to do follow up studies, you have to do follow up questions by two weeks, three weeks, that becomes less of a priority for her. Right? And so where I’m really going with this is we cannot try and solve for the diversity in research without addressing some fundamental things like poverty, education, just education status. Where we know that people that have a high school diploma or people that have a bachelor’s degree, pardon me, are more likely to be healthier. That’s just a simple fact because they’re a little bit more educated about their health and their condition. So definitely addressing it from an education perspective, I think addresses a barrier. It’s also definitely important to, again, encourage more people of color to go into healthcare professions or even research. Definitely leveraging the community centers that already exist as a gateway to recruit more participants. I cannot understate that. I am much more likely to trust somebody that I sit next to in church to be like, oh yeah, by the way, I, you know, I’m a nurse at St. blah, blah, blah hospital. We’re doing a study. Do you want to participate? Right? Much more likely that person is going to participate than me, even if I look like them and I show up to the church and I’m not a member of that church. Do you think they’re going to trust me? Absolutely not. Right. So yeah, so this is just a few pointers. I wanted to really highlight that because I know it affected me personally and certainly for someone that’s looking to do research and get into research should definitely use some of those tools. 

Bunmi Ogungbe (38:48) 

You know, you make such an excellent point. What you said just now, we’ve heard, that and I personally have heard that repeatedly and also recently in the community, people went, you are answering this question and I’m responding to you and talking to you about research because I know you. And because I kind of trust you. If someone else came who doesn’t look like me was the word you use, and asks me this question, I will not give them the time of the day because I would be like, what do you want to use that information for? So really bringing in mistrust and how it’s important that we work, it’s maybe hard work to earn trust. Trust needs to be earned and starting in the community, like you said, faith-based organizations and churches and the mosques and the trust spaces, there’s some programs that my colleague and I are hoping to start, we’re calling it trust spaces. It’s trust, but really working in trust spaces, barbershops and nail salons and beauty salons. People are coming in, people tend to go to those places. They tend to really talk a lot about even personal issues in those spaces and maybe to an extent, they trust their hairstylist. They trust someone that they’re interacting with and someone sitting beside them. Like you said, Marty, at church says, hey, you know, I’m a community research ambassador, I have been trained. We have this study, might you be willing to participate?  

So those are some innovative ideas that colleagues and I are beginning to come up with. Another one I should mention is this is actually a company called Mizizi that a group of black women, three black women are starting. And all they are doing is what we’re talking about, really going into community training, people in community that is part of capacity building, is part of increasing awareness, part of increasing just education, like you said. So training people as ambassadors in the community and mainly focusing on black and brown communities and increasing their participation in trials, especially in clinical drug trials where there’s just the numbers like we said in the beginning is just really bad and abysmal. So really wanted to put that in because that’s such a fundamental point that a lot of people, trialists, can miss. It’s very easy to miss. 

Martinien (Marty) Cho (41:21) 

I think one thing that you also touched very briefly on as far as like, you know, how do you get people in rural areas to become more involved in research when most teaching centers, right? Like highly funded hospitals, they rarely exist in rural areas. Most of the times those patients have to travel sometimes an hour, two hours, even three hours to get to those facilities to get that level of care. Now, when it comes to something, I think you can maybe talk a little bit more to this, Bunmi, since you’re much more of a researcher and you’re on the ground doing the research, I’m just a consumer of research and I judge it.  

Bunmi Ogungbe (42:03) 

Thank you for judging. That’s important. 

Martinien (Marty) Cho And so what I’m really trying to highlight is I feel like when it comes to research, the template hasn’t really adapted, right? And what I mean by that is, 

You cannot use the same template to recruit your participants in a major metropolitan area like you would in a rural area. So that’s one. Secondly, when you do apply for a grant, and I know a lot of times you get a grant, like the grant funding organization, they want to know every dime and every penny accounted for, right? And I feel like again, some of these templates already exist where you just say, okay, I’m going to get a grand for you know, $100,000, 50% is going to go to us this well, maybe that same template doesn’t apply to like a rural community. and like good ‘ol Alabama, right? So maybe in that community, wait, maybe we need to flip the script and say, you know what? No, let’s forget about like, you know, paying for this and paying for that. Let’s try and see if we can partner with Apple or Google to get these people cell phones, refurbished cell phones for a much cheaper price so they can actually participate in these studies. 

Now you push it in further and say, what does the people that live in a rural community, do they have wifi? They don’t always have reliable wifi, right? And so again, you have to be adaptable. And I was like, what are some of the barriers outside, like really think outside of the box that you are likely to face as a researcher based on your target audience? In the tech world, we call it product market fit. Who are you trying to solve a problem for? And have you gone and actually talked to them and figured out what the pain points are? I think really leveraging that approach to research in healthcare would really change the landscape and actually would really go and would give us the diversity and what we’re really trying to accomplish. 

Geralyn Warfield (44:08) 

I would say that one of the things that both of you have touched on that I just want to reinforce with our audience is that it takes a concerted effort and it’s a longitudinal effort. It’s a long-term effort. You don’t just show up at somebody’s door and expect them to participate when they don’t know you. So I think a lot of organizations are actually more engaged with the community on a long-term basis. They might be doing community outreach events on a regular basis. They might be hosting blood pressure screenings at churches, for example, on a regular basis. So that they’re present and it’s not just transactional for the people that are involved. It’s really that we’re all in this together and we’re trying to make life better for all of us, but particularly those of you that for a lot of reasons haven’t been as engaged in the process. So I think that’s what goes a long way towards making these processes work for researchers, processes work for the patients that we’re trying to recruit. 

Bunmi Ogungbe (45:03) 

Okay, I was going to extend what you just which is that the investment in community needs to be long-term. One of the examples that we’ve provided to some of our commercial funders is if we are trying to, and this is in a cardiovascular space, if we’re trying to increase physical activity as an example, if a company with their brand that is known comes and fixes a park in the neighborhood, people would remember that. People would remember that and if people come back and say, we are looking to engage with you, we want to partner with you long term, there’s probably a higher likelihood of receptiveness to that. So yes, there’s a lot of that community engagement, community screening going on. In addition to that, there’s just got to be this deep investment in community. The social determinants of health, we talk about that a lot. 

And this has happened in community settings where people, would present about a project we’re trying to do and people are like, yeah, it’s good, but it looks like putting a bandaid on it, we really truly need you to do something a bit more substantial. And then sometimes I’ve gone, you know, we really don’t have the funds, the expertise to completely transform the neighborhood, we really would want to do that. So those are things that we should probably advocate for a bit more. Especially for companies or enterprises that are able to do this, but also policy-wise, there’s a lot of advocacy opportunity here. How can we craft policies that really invest in communities and really center ensuring that those hidden costs that we talked about, these barriers, do not continue to persist? And one other thing I would say to something Marty was saying earlier, there’s this concept of, on integrating technology or leveraging technology. There’s a concept of reciprocal innovation. And this concept is that there are some low fidelity, low tech devices or technology that can be leveraged. In some of my work, I do some global health work. And in some of my work, we’ve actually taken some technology that has worked in what we call low and middle income country, jury is out on continued use of that term. But there’s some devices, some technology that has worked. We can collect data offline. People don’t have to be connected to Wi-Fi all the time. We could have syncing, you know, syncing the specific devices with their blood pressure monitors, and this is like Bluetooth enabled. So they really don’t have to have the high tech to do that. And we take some of those ideas and some of this technology and we try to implement them in rural areas in the United States for instance, where there is just that similarity in terms of access. And some of these things have worked. We don’t have to always go back to the drawing board. There continues to be, we’re in a fantastic time, technology-wise, and we should really leverage those. 

There is the partnership that we call it community, academia, government, and industry partnership. That really needs to happen. Maybe this is part of reimagining how we do research. Everybody has got to be involved. shouldn’t just leave it to the academia and government alone. really should see the role, industry plays a lot of role, ensuring we’re strengthening that partnership, doing something that is going well technology-wise, how can we integrate that and leverage that in research? 

Martinien (Marty) Cho (48:27) 

Well said. 

Geralyn Warfield (48:28) 

All right, my final question for both of you, we have again covered a lot of different topics related to diversity in clinical trials. And if you could have one takeaway for our audience, what would that be from our conversation? And Marty, I’m going to start with you. 

Martinien (Marty) Cho (48:44) 

Yeah, I think A is the realization that, you know, it’s a continuous effort. And we have to approach it with a very clear fresh set of eyes is the way I want to look at it. And really realizing that this is not just a pinpoint issue. It’s a systemic issue and needs to be approached as such. And start young. Let’s target people when they’re still in high school, middle school, get them excited about doing research, reward them for doing research. Make it be comfortable, make it be fun. So then when they graduate high school, they go to college, they are the future researchers, right? And so then that kind of spreads around the community. I’m a very big advocate for grassroots movements, you know, start from the ground up, right? And then hopefully the tree becomes a healthy forest one day. 

Geralyn Warfield (49:35) 

Bunmi, how about you? What are your final words for us? 

Bunmi Ogungbe (49:38) 

I’ve got two Rs. I was looking for thinking of a third one. My first is reimagining how we run trials, reimagining the participation of underrepresented minoritized groups in trials, reimagining participation of nurses in research as trialists, as research managers, as search coordinators, as essential to this process. So that’s my first R, reimagining this. We can transform a lot of things if we just imagine, we think outside the box as we’ve sort of talked about, as we’ve mentioned previously.  

And then my second R is rebuilding trust. We have a lot of work to do and we need to rebuild trust with communities, with patients, even as we deliver care, ensuring that people do not continue to see hospitals and academic centers and researchers as places where they have to go only because they, well, yeah, people have to be there only because they have to be there, but there is just that lack of trust that has fed that for a long time. And just really doing the work of rebuilding that trust, I think would really have a lasting impact and would bring us towards health equity, which is what a lot of people are aiming for these days. 

Geralyn Warfield (51:04) 

We are so grateful to both of you, Martinien Cho and Dr. Bunmi Ogungbe, for being with us today and helping us understand both historical and current issues that are addressing diversity in clinical trials and how we might be part of the solution that is so sorely needed. Thank you so very much for all of your nuggets of information that you’ve shared. We’d also like to thank Cytokinetics, Incorporated and Novartis Pharmaceuticals for their support for this particular podcast episode. 

And as we mentioned earlier, you can find the links that we’ve described to these resources and maybe some even other ones that we will put in the show notes. So you’ll want to check those out. This is your host, Geralyn Warfield, and we will see you next time.