Just Ask: Increasing Diversity in Clinical Trials
Listen to the podcast to hear Dr. Barrett talk about:
why diversity in in clinical trials is so important
what the Just Ask program is and how it works
reactions to the program
her recommendations for people who want to be part of a clinical trial
Dr. Barrett is a medical sociologist, assistant professor of family medicine and community health at Duke University School of Medicine, founding director of the Office of Health Equity and Disparities at the Duke Cancer Institute, director of the Center for Equity in Research within the Duke Clinical and Translational Science Institute, Durham, NC.
— Last updated on August 24, 2022, 10:24 PM
This podcast episode is sponsored by Genentech, Bristol Myers Squibb, AstraZeneca, Novartis, Daiichi Sankyo, Seagen, and Eisai as part of the #BlackDataMatters When We Tri(al) movement.
This podcast is sponsored by Genentech, Bristol-Myers Squibb, AstraZeneca, and other sponsors of the Black Data Matters When We Tri(al) Movement.
Welcome to the Breastcancer.org podcast, the podcast that brings you the latest information on breast cancer research, treatments, side effects, and survivorship issues through expert interviews, as well as personal stories from people affected by breast cancer. Here’s your host, Breastcancer.org senior editor, Jamie DePolo.
Jamie DePolo: Hello, thanks for listening. We know that only about 9% of eligible people choose to participate in clinical trials for new medicines and other treatments, but this statistic is even worse for people of color. According to 2020 numbers from the American Cancer Society and the Centers for Disease Control and Prevention, 12% of new breast cancer cases were diagnosed in Black people, but Black patients made up only 3% of the participants in breast cancer clinical trials that led to Food and Drug Administration approvals between 2008 and 2018.
Dr. Nadine Barrett, Duke University Assistant Professor of Family Medicine and Community Health and director of the Duke CTSI Center for Equity in Research, joins us today to talk about Just Ask, a program she leads that aims to increase diversity in clinical trials by educating both patients and researchers. Dr. Barrett, welcome to the podcast.
Dr. Nadine Barrett: Hello. Thank you so much for having me. Thank you.
Jamie DePolo: Now, this answer may be a little bit obvious, but can you talk about why it’s so important to have diverse participation in clinical trials?
Dr. Nadine Barrett: Oh, absolutely. Again, thanks for having me here, and I think it’s really important that we’re having this discussion because there is such an important need to ensure that we have diversity in our trials.
There’s multiple reasons. One in particular is that we know that if we have the diversity we need, that the generalization of results — so when we actually look at the results from clinical trials — we should be able to say that these results are reflective of what we see in the general population, our community, our country. And in most clinical trials, in fact, we don’t see that, just as you highlighted in the data that you just shared. And so what we do know is that if we don’t have the representation that we need, therefore, we cannot really be able to ensure that everyone gets the appropriate services, care, and treatments. And to even have that treatment response is critical in terms of having that diversity. So diversity is important primarily because we want to make sure that it reflects the diversity of our population and we know exactly how it impacts that drug, that treatment impacts the entire population equally and equitably.
Jamie DePolo: Thank you. And I’ve also read some things that say just because a new drug is shown to be, say, this percent effective in a clinical trial, if the clinical trial’s makeup is all one gender or primarily one gender or primarily one race, we’re not sure that then those results apply to people of other genders and other races, right?
Dr. Nadine Barrett: Absolutely, and that’s exactly the point. Yes, we have to have that kind of diversity because the fact that reality is, is that if we don’t have the representation on that study that reflects our broader population, then, yes, we don’t know what's going to work for whom and when/at what point. So I think it really is important, and I know that it’s important that we have the appropriate diversity. And it’s an equity issue, also, right? So one is generalization, the other part is also equity.
In many cases — not all, but in some cases — people may very well be able to get access to potentially lifesaving or at least life-enhancing treatments while on a clinical trial. If they don’t get to participate, if they're not invited to participate or they don’t get access to that — and most clinical trials, as we know, are most certainly focused on addressing some of the most cutting-edge needs around cancer treatments. And again, if people are in clinical trials, this could actually create an opportunity for either prolonging their life or enhancing the quality of their life.
It also is important because we want to know how this drug works beyond the current patient, but also how do we really work toward finding a cure for these diseases for the long term?
So there’s multiple reasons why we want that diversity, all of those important generalizations so that we can make sure how it impacts a variety of populations and the diversity of our population; most certainly ensuring that people get access to cutting-edge treatment and care, equitably; and also, ensuring that we can work towards finding a cure if we have that diversity that allows us to make inferences or understand the results and know what those results mean for the broader population.
Jamie DePolo: Thank you. Could you summarize the Just Ask program for us? Tell me a little bit, when was it developed, how was it developed, how does it work?
Dr. Nadine Barrett: Sure. So, interestingly, the Just Ask program came about initially because I’m actually a medical sociologist in my training. So in my work, I’ve always looked at this concept of race and ethnicity and diversity and how that impacts people’s lived experiences, whether it be socioeconomic, whether it be related to housing, whether it be related to… particularly around healthcare and health outcomes. So it was an idea to really start thinking about how do we look at these differences and then recognize the role of inequities, discrimination, racism, bias, and how that plays out in healthcare.
We know that in research, historically, there’s been a lot of research that’s been done in other diseases that’s highlighted that there are biases that providers have that impacts the care that patients receive, assumptions that people may have, a perspective that people may have that may not necessarily reflect that patient or that person that they're working with. And so it just made sense that just as this happens in a patient/provider encounter during a hospital visit, there’s no reason why we would think it does not exist in the realm of cancer clinical trials, as well, because it's still a patient and a provider interacting, it’s still happening within a clinical setting, and it’s still about medical care, if you will — we would add the extra lane that this is also a clinical trial.
So essentially, what I wanted to do is start developing some training and skills to be able to help our research workforce — who are also providers, who are researchers, who are teams that are focusing on the administration side of a clinical trial — to really learn about their biases and start thinking more strategically about how they can be more effective. Because these biases are oftentimes like blind spots that people don’t even realize that they have their biases — that’s why they're unconscious bias or implicit bias. And so we really worked on helping them to understand that so that they can then become more intentional with the appropriate tools and strategies to be able to be more effective and being able to engage a diverse patient population regardless of their race or ethnicity. And also, in giving that serious consideration of the fact of race and ethnicity and how there’s a broader system that most certainly perpetuates inequities that people experience on a day-to-day basis, and when they come into our clinic to participate in a research study or they come to our clinic and we want to invite them, that we are aware of those factors and making sure that we are engaging patients in a way that’s really respectful and honors who they are and their lived experiences.
Jamie DePolo: Okay. So, could you tell me a little bit what actually happens, like I know you work with both researchers and with patients, educating them both. So if you could maybe give me a little example of how you might work with a researcher as well as how you might work with a patient?
Dr. Nadine Barrett: Yeah, absolutely. So, the Just Ask program was also co-developed with community members, community organizations, community leaders — like AME Zion Hill is one group that’s a group of faith-based churches, actually, across North Carolina, that partners with Duke to really address increasing diversity in clinical trials.
We also worked with patients to understand what were the challenges that they were experiencing and what would they like to see different in that experience and in that encounter and being asked to participate in a clinical trial. And as a result, Just Ask then came from both the training that we have, what we know about sociology, and what we know about implicit bias, and what we learned from our patients and our community to identify what would work.
So both community and providers highlighted that there were two needs. One was specifically around engaging the health system — those who were involved in providing care, the research team, as well as engaging our patients in knowing what they need to know about clinical research and trials, and what they need to know to be able to ask about participating. The biggest impetus for Just Ask is this: the number one reason why most people participate in clinical trials is because they were asked. Someone spoke with them, they were informed. The number one reason why most people don’t is because they weren’t informed, nobody asked them, no one talked to them about the possibility of exploring participating in a clinical trial. So hence, that’s where the name came from, Just Ask, and then it became a “just ask” where it was our patients who were saying that our providers need to ask. They also wanted to be empowered in their own way to be able to ask as well when they are dealing with a chronic disease such as being diagnosed with breast cancer or prostate cancer or kidney disease, for that matter. So again, that’s where it came from, and that was the focus.
So it’s a two-part training. One side is with the providers in the research space, and the other is working with our communities and community partners to be able to actually do the Just Ask training from a patient perspective. So those are the two key parts of it.
So when we meet with a patient… or actually, let me start with the research side. When we start working with researchers, what we tend to do is first, do the training. The training is multifaceted. We first find out what their needs are or they identify what their needs are. We look at where they currently are in terms of increasing diversity in clinical research and trials, we think about what barriers there are in place that we know nationally impact people in not being able to participate, and we work together to kind of identify ways to help remove those or alleviate those.
And then the actual training itself walks people through this process of where they first understand the importance of that diversity — so the questions that were asked earlier — they then learn about their own perspective and how their own bias may show up. And they go through some specific exercises in which they actually see their own bias shows up, and there’s just the kind of aha moment, if you will, where they say, “Wow, I didn’t even realize that I had that perspective,” or, “I don’t even know where that came from.” And it’s because our biases, especially implicit bias, comes from so many factors, whether society, things that we hear through the media, it comes from how we were raised, our communities, et cetera. So there’s all different ways that, as we go on our life journey, that we learn these messages. And these messages are oftentimes subliminal and as we learn them, we implement them, as they become stereotypes or assumptions of different groups or groups that are different from us.
So, essentially, they go through this training and then they learn more about that, then they understand equity and equality and learn the differences between those two terms — and what we’re really striving for is equity, and equity in clinical trials is critical — they learn about the lack of diversity in the trials, and then we start working specifically toward looking at their studies, their work, and what are the factors that’s stopping them from just asking, and then what do they need to do to go beyond the “just ask” to engage more diversity in the population.
Jamie DePolo: And on the patient’s side, how does that work?
Dr. Nadine Barrett: Yes, perfect. So, on the patient side, it’s interesting. So we kind of looked at this as both a patient side/community side. One of the visions that I’ve always had and the goal of this is to really get people to this point when our communities, where they hear about clinical trials and it is the norm to hear that, and it’s not like this strange concept or this weird, abstract thought about participating in a clinical trial.
Oftentimes, when people think about a clinical trial, they’ll think, “Oh, it’s this big, white, stainless steel, white, sterile room, with someone in a long, white coat with a needle ready to inject you. And so this is the picture that people typically have, and the reality is is that clinical trials happen in your regular clinic where people go and have their doctor’s appointments. And so that’s where we’re really trying to kind of help people to want to see that.
And then, also, understanding the benefits of clinical trials. And this is what we do in the patient and community training is that we help people to recognize that there’s benefits there. So one example is that I’ll ask questions — not to raise your hands — but for example, how many of you are taking metformin or know someone who is taking metformin for diabetes, or how many of you are or know someone taking medications for blood pressure, and they fill it at Walgreens, CVS, or any other local drugstore and take it without any questions. Why can you take it so readily without any question? Because clinical trials is what happened in order to make these drugs readily available. So these are common drugs, but it’s the same thing that happens in the cancer space, right, in breast cancer clinical trials as well. So one part where the community said and patients said is that the idea around what clinical trials are in our community needs to be normalized.
So that’s a key part of the training for us is helping people to understand what clinical trials are and what they're not, help to debunk some of the myths while also validating some of the atrocities and history that has happened that make some groups, particularly African Americans, less likely to want to participate. Because of the medical atrocities and research atrocities that have happened in the past, as well as current experiences with different social systems. So they really embedded that. So the training in that space is really helping our communities to understand and kind of see this whole idea from what it is. It’s a clinic. It’s not this sterile room that oftentimes you see on TV [laughs] that it perpetuates.
And then we go from there into the next part, where we really talk about why would they participate or why would it be important to ensure there’s diversity and what roles they can play.
And so what we end up with is a group of ambassadors, if you will, that goes through the trainings, and then they become people who either want to participate as a patient — some of them are patients that have already participated and want to learn more, they want to become ambassadors to help others. So we have men that have prostate cancer, some women that have breast cancer that all are now ambassadors who sit on research studies to help design and help think about putting the patient center in the development of a clinical trial all the way through to how do we make sure that patients, and particularly underrepresented race and ethnic groups and women, are invited to participate, and how can they help the teams to do that.
So the training on that side for the patient and community is supposed to help them ask, if they need to, as a patient who wants to learn more about a clinical trial or what might be available for them. It’s also for those who are patients and community members who want to become advocates of increasing diversity in clinical trials.
Jamie DePolo: That sounds amazing. I’m wondering what the reactions have been, are the reactions different between the two different groups, between the researchers and the community and patients?
Dr. Nadine Barrett: Yeah, you know, that’s really interesting. The community and our patients are really… patients tend to kind of say, “Why have I not been invited?” [laughs] That’s one question. “I’m a patient, I’m getting treated for breast cancer, how come no one’s ever spoken to me about the possibility of participating in a clinical trial for my disease?” And so that’s one response we get very often, and we really help people to both understand the why and then also arm them with the resources, information, and tools that they need to be able to ask those questions, so that the Just Ask can sometimes come from the patient, as well.
I personally subscribe to the idea that it really should be something that comes from the health system and from the researchers and those who are providing care primarily, and especially if it’s an institution where the research is already happening there, it only makes sense that part of that should be to let patients know all their possible options including participating in clinical trials.
So that’s one side. But I think the biggest thing that's highlighted is just that “aha” moment of recognizing their own implicit biases that have been well documented in the literature, and there’s research that’s shown this for years. And again, these implicit biases are not unique to researchers, research teams, and providers, we all have it. Every single one of us have it. If you're a human being, you have them. How they're shaped and how they impact how we interact with people is what makes the difference, right, whether we discriminate or we may not offer someone something because of the thoughts that we may have that they’ll say no because of things that may not be true, right? So we all have it, but they're more shocked about what they see, and then they become even more excited about wanting to make sure that they're giving the best patient care that they can.
So again, I think that those are the opportunities. And then some people are like, “I’m not sure about this implicit bias thing,” which certainly comes up as well, but for the most part we've seen — even in our outcomes, we've seen — a significant difference in terms of people’s understanding before and then their understanding after of their perceptions around patients, the assumptions that they may have had around patients and communities and groups that may be different from them, and then learning the strategies for them to kind of, if you will, try to… you can’t really unlearn what you’ve learned in terms of implicit bias, but become aware of it so that you can utilize those strategies to say, “How do I make sure that I’m recognizing the patient for who they are and asking them to participate and making it be something I ask every patient instead of being selective on what patients I ask,” at the forefront.
Of course, there’s other factors that play into actually being able to participate, but simply asking people if they're interested in learning if they could possibly be a part of a clinical trial or if there’s a clinical trial that’s right for them, making sure that conversation happens.
And so it’s an interesting response from both sides. The patients definitely get excited about it, and they ask why not, why have they not been asked, then they get fired up that they can be a part of it, potentially. And then the second is that the researchers tend to learn more about their biases and learn to adjust that.
And I’ll also add there’s a phenomenal study that came out from Raegan Durant and his colleagues, and that actually worked specifically around cancer, and it was asking research teams across comprehensive cancer centers what are the factors that impact lack of diversity in clinical trials and specifically around them engaging their patient population in that. One of the biggest findings that came from that was that there were assumptions that the research team members were making about particular patients, particularly in racial and ethnically minority patients, that led to them not asking them to participate in trials. They would assume that they may not adhere, they might not follow through with the study, they may say no anyway, they might not be interested. All these different assumptions that were made, and yet they were never grounded in anything other than just assumptions that people have about a variety of different racial and ethnic groups. So again, the Just Ask program is perfect because it really speaks to the points that came out in that study and particularly in cancer.
Jamie DePolo: Oh yeah, and it sounds like your program is helping both groups, patients and researchers, take steps forward to maybe help make trials more diverse. I believe the Just Ask program started as a pilot program, is that right?
Dr. Nadine Barrett: Yes, it did. It started as a pilot program in oncology here at Duke where we were able to see a significant difference in growth from before the training — the oncology staff, research staff team, 120 of them, went through the training, and before, they had a very low understanding of diversity, race, ethnicity, differences in terms of patient care. They also did not have an understanding of equity and equality and how being asked or what it means to be asked and what participation in clinical trials would mean. They also were not necessarily as clear about all the different benefits that come with participating in a clinical trial, particularly for our underrepresented race and ethnic groups and the diversity there that’s needed. And at the end of it, we saw a significant increase in their growth and understanding of all of those factors and in the strategies that they can implement toward being able to address that.
It’s not a one-off show, and I think it’s always important for me to say that — you don’t get one training and now you’ve got it. I believe that anything along these lines is always a journey, not a destination, and so it’s the ongoing learning. So there’s opportunities for people to do refreshers, other readings that people could do, other group meetings, group sessions, and also some practical application of looking at what patients in their cancer center that they could look to, to identify and participate regardless of their race, ethnicity, et cetera, but in fact, being very intentional, however, about recognizing Black/African American, Asian-Pacific Islander, and Latinx populations as well. So it’s really about them becoming more aware of it and then developing their own strategies to be able to be more intentional on asking, engaging, and being culturally respectful and responsive and humble to the diverse populations that are coming in for care.
Jamie DePolo: Well, it sounds like the program has done a lot of good work, so I’m wondering what is its status now, are you expanding to other institutions, is this something you’d like to grow nationwide, is it being presented to researchers as a tool that they can use when they're developing studies? How are you moving forward?
Dr. Nadine Barrett: Yes, actually there’s been an incredible amount of interest in Just Ask both nationally and across our region, for sure. And so there’s different versions of it, there’s actually one where I come and we do a talk that’s like an abbreviated talk for an hour-and-a-half to different research teams or to agencies and organizations that really helps to kind of start wetting the palate, if you will, around that space.
The actual trainings for a research team has turned into an LMS module that we actually now have done here at Duke across multiple cohorts, now, not just in cancer but all disease groups across the institution who are doing research, they all now are going through this training. We've had several cohorts that have gone through, and it’s part of a broader engagement recruitment and retention curriculum that we have here at Duke, now, and Just Ask is the framework in which that entire training is provided for clinical research teams.
That’s exciting because both the face-to-face and the LMS modules that people can do — which is a learning management system, LMS — allows them to be able to learn it both on the computer in their own time but also learn it in person, as they go through this interactive group sessions, breakout sessions, et cetera. So that’s been amazing, too, to see the outcomes from that process.
And now, as I said, nationally, we’re looking toward wanting to expand it most certainly across the country, and certainly across the region, as well, for cancer centers to be able to apply this in different spaces. So even if it’s a large comprehensive cancer center or a small community cancer center, either one will benefit from their teams getting this type of training and then being able to collaborate, partner, or work with patients to be able to increase diversity and increase access to clinical trials in their areas. That includes rural populations, urban populations that have a high representation of underrepresented race and ethnic groups, African Americans, Latinx, et cetera. So yes, it does allow for those kinds of types of opportunities, and we are looking to expand that now. And it is expanding.
Jamie DePolo: Oh, that’s very, very exciting. I’m wondering, finally, if there’s somebody out there who’s listening, what do you recommend people of color do if they want to be in a clinical trial, if they want more information, how do they figure out if they're eligible. What are some steps that they can do to start if maybe the Just Ask program isn’t in their area yet?
Dr. Nadine Barrett: Yeah, that’s a great question. So, I would think that… I will have to just give a special plug to several resources, but one in particular is Breastcancer.org, which has a great website that really highlights clinical trials and the importance of it, and even strategies. So, a special report was done by the group just earlier in this year really highlighting different resources and questions that you can ask your provider. When we talk about it from a very lay perspective, I think it’s very lay friendly, and it also recognizes the disparities that exist where African American women are more likely to die from breast cancer compared to their white counterparts, they speak to that. And then also that site allows you to understand clinical trials and what the possibilities are. They even talk about what barriers are there and potential ways to be able to work through that. So I would first and foremost encourage people to explore that website. And then that website also, in fact, has different ways for you to identify the FDA and other groups, the National Cancer Institute, they also have great resources, as well, to be able to learn more about cancer, what clinical trials are available to you, and how to navigate, how to ask questions around that.
The last one I would add is the American Cancer Society also has a great navigation program in that space. But for a first step, I would actually encourage your first lay step, as a patient, who’s just learning or wanted to learn more, I would mainly encourage people to look at the Breastcancer.org website, and be able to look at that and see what's available there.
Jamie DePolo: Oh, well, thank you so much for your kind words about our website, that’s very appreciated. And thank you so much for all this helpful information. It sounds like a wonderful, wonderful program, and I wish you much success with expanding across the country, it does sound like it’s needed everywhere.
Dr. Nadine Barrett: Oh, absolutely, absolutely. We also have information about Just Ask on the Duke Cancer Institute website and on the Duke Clinical & Translational Institute. And so if anyone just puts in Duke Just Ask in Google, it should probably pick up, and you'll certainly be able to connect to our office over here, who could help in any way possible to support that work.
Jamie DePolo: Great. Thank you so much, Dr. Barrett, this has been really informative.
Dr. Nadine Barrett: Thank you. It’s wonderful, and thanks for all the work you're doing, it’s really inspiring the work that you and Breastcancer.org does to really make sure that people have the information that they need in their hands in a practical and real way that they can act upon. So thanks for all the work that you do, as well.