The Importance of Diversity in Breast Cancer Clinical Trials
Studies show that overall participation in cancer clinical trials is low, and participation by people of color is even lower. This is thought to be part of the reason that minority women — especially Black women — have worse breast cancer outcomes than white women.
One strategy to help reduce disparities in breast cancer outcomes is to make clinical trials more diverse.
Listen to the podcast to hear Dr. Lola Fayanju explain:
why diversity in clinical trials is important
some of the barriers that keep people of color from enrolling in clinical trials and how they can be overcome
how she talks to all her patients about clinical trials
Dr. Fayanju is the Helen O. Dickens Presidential Associate Professor and chief of breast surgery at Penn Medicine, the University of Pennsylvania Health System in Philadelphia, PA
— Last updated on February 11, 2022, 9:20 PM
Jamie DePolo: Hello, thanks for listening. Our guest today is Dr. Lola Fayanju, the Helen O. Dickens Presidential Associate Professor at the Perelman School of Medicine at the University of Pennsylvania, where she is also chief of breast surgery at Penn Medicine, as well as surgical director of the Rena Rowan Breast Center. Dr. Fayanju’s research focuses on health disparities, aggressive breast cancer variants, and improving value in oncology. Her research is supported by funding from the National Institutes of Health and has been published in a variety of journals, including Annals of Surgery, Cancer, and JAMA.
Studies show that overall participation in cancer clinical trials is low, and participation by people who identify as a race other than white is even lower. This is thought to be part of the reason that minority women, especially Black women, have worse breast cancer outcomes than white women. One strategy to help reduce disparities in breast cancer outcomes is to make clinical trials more diverse. Dr. Fayanju joins us today to talk about why diversity in clinical trials is important, as well as how some of the barriers that stop people from enrolling in clinical trials can be overcome.
Dr. Fayanju, welcome back to the podcast. It’s really nice to talk to you again, and I want to congratulate you on your new positions at UPenn.
Dr. Lola Fayanju: Thank you so much. I’m really glad to be here.
Jamie DePolo: So, let’s start. Can I ask you to explain why it’s really important to have more diverse participation in breast cancer clinical trials?
Dr. Lola Fayanju: Well, as we develop clinical trials and the devices and/or medications that we are testing in those trials, we want to make sure that the results of our trials, that is the conclusions that we learn from the trials, are as applicable to as many people in the population as possible. And we can ensure that by making sure that to as great an extent as possible, the cohort in our trials reflect our population of patients. The less that they do that, the more concern there may be that for various reasons we can’t necessarily rely on having the same results in people from different backgrounds not represented in the trials.
This is because, for example, there are sometimes certain subtypes of disease that are, let’s say, more common in certain groups. And so, we also know that the pathways or the mechanisms to which that disease develops may also be more common in those groups. So, if the intervention we’re testing doesn’t specifically address that pathway then it’s possible that people who are part of the groups in which that pathway is more common are less likely to benefit from this generalized intervention.
In addition, we learn a lot more about the pathophysiology of cancer and other diseases if we have diverse participation. Because if we make sure we have adequate representation of individuals in whom a particularly aggressive variant is more common, we learn more about how that disease evolves in general. We’ve learned lessons in this way from prostate cancer, where more aggressive variants of prostate cancer are more common in men of African ancestry. Doing research on those variants has shed light on the pathophysiology of prostate cancer in general, allowing us to target SNPs, or single-nucleotide polymorphism, that may
be more common in those variants and may be potential targets for treatment. So, that’s the second reason why participation is important.
And then third, diversity begets diversity. That is, if you have more diverse trials, individuals who might be interested in participating in a trial are therefore more likely to trust the trials will include and treat well people who look like them.
So, for all those reasons — that is, in order to improve generalized ability of trial results, in order to learn more about the pathophysiology of aggressive variants that might be more common in diverse populations, and, finally, to ensure trustworthiness in the medical establishment with regards to trials, thereby encouraging diverse participants to want to join trials because they see people who look like them are already in trials. All of those are reasons why it’s important to have diverse participation in clinical trials in general and particularly in breast cancer clinical trials.
Jamie DePolo: Okay, thank you. Thank you, that was very informative. Now, I want to talk about some of the barriers that I’ve read about that stop people from being in clinical trials. So, what I’d like to do is bring up a barrier, and then maybe you could explain why it’s a barrier or how it developed and how you think strategies are being put in place to overcome it. So, the first one is one you mentioned in your answer to the first question, which is mistrust of the medical system or fear that somebody is going to be exploited. I’ve heard that or have seen that, rather, in several studies.
Dr. Lola Fayanju: You know, that is something that is cited regularly not only to explain why there is less diversity in clinical trials, but why people of color might also be more reluctant to take advantage of innovations in medicine including the COVID-19 vaccine. And what I would argue is that we need to flip the script when talking about patient mistrust and think more about system trustworthiness. That is, what has the medical system done to justify the trust, to earn the trust of populations that have historically been exploited? People often cite the Tuskegee experiment, which many people may not know. What that involved was where individual Black men who were known to have syphilis were left untreated for their syphilis for years in order for the researchers to observe a natural history of syphilis, despite the fact that at the time, a known antibiotic treatment was available.
And it was really one of those things where, “Let’s just see what can happen so we can.” And so these individuals suffered secondary and tertiary syphilis, which many people may not know involves incredibly debilitating and painful neurocognitive deficit that these men went on to suffer and die from, as a result of deliberate nontreatment of a condition that was treatable.
So, Tuskegee gets cited as a reason for why people are afraid of clinical trials, but people need to realize that people’s mistrust of clinical trials is not so much because of Tuskegee, even though that’s cited, it’s because how people are being treated right now. The truth of the matter is, there is still systemic racism throughout the medical profession that is recognized and unrecognized.
Patients are aware of when they are not being treated equitably. They know when they’re less likely to be offered certain types of treatment because their nonadherence is presumed. And so, yes, there is some level of medical mistrust amongst patients of color that is justified not
only by historical events, but also by current events and the current way in which many of them are treated. And so, we need to work not so much on disabusing them of that trust, but more working to ensure that we have earned the right for them to trust us.
Jamie DePolo: Thank you for that. Now, another one I’ve read a lot about is lack of awareness. And there was just, I think, a study that came out — now, I thought it was recently but maybe it was just that I read it recently — where doctors are less likely to suggest a clinical trial for their patients of color.
Dr. Lola Fayanju: So, yes, that is a very important point. So, lack of awareness versus deliberate nondisclosure about trials is kind of a confusing issue. So, one, I have to emphasize that many physicians themselves may not be aware of the trials in which their patients are eligible. So, often, if a patient is not connected with a trial, it’s not because of a deliberate willingness of a provider not to connect someone with a trial for which they could potentially benefit. It’s often because the oncologist or more likely the primary care physician may not know that a trial exists. So, that is something that we need to work on, is awareness amongst
clinicians about making trials available to their patients and becoming aware of those trials in the first place.
On the part of patients, there may be a lack of awareness of which trials are available to them as well, because patients of color or patients from low socioeconomic status may be less likely to go in search of trials. They may be less likely to Google or ask their friends about trials that they might be eligible for. And so, what I have found working at academic medical centers is not infrequently, more well resourced individuals will come to our medical centers in search of a trial they think that they might want to participate in. And that type of autonomy is not something that we may see as much in certain communities. So, I think we need to work on lack of awareness both among providers and also among patients who are potentially less resourced and also less connected to the medical community in general.
Jamie DePolo: Okay. Okay, thank you. And I will say, just as an aside on that, I know many, many groups have tried to make clinical trial searching less confusing. But there are just so many parameters and so many different things that are allowed and not allowed that even for somebody who is really gung-ho, it could be very confusing to figure out which trials are appropriate.
Dr. Lola Fayanju: Absolutely. I will tell you that I am a mother of two boys, and I was very keen to get them involved in a COVID-19 vaccine trial. And even I, as a clinician, had a very hard time finding which sites might be open and would be available to them for their age group and in our region. So, finding a trial that is something that you’re eligible for is actually really challenging, and we found that even with regards to testing the COVID-19 vaccine. It’s been really difficult to ensure diversity in these trials at some level, especially in the early-phase trials, because it was a privileged few who had the time, the leisure, opportunity, and the ability to access the trial registration site.
Jamie DePolo: Okay, thank you. Now, one other thing I’ve read, too, is just basic logistics. Somebody lives too far away from a site. Somebody maybe can’t get there as often as needed. To me, that seems like a really tough one to overcome, because a lot of the trials are done at academic medical centers.
Dr. Lola Fayanju: Yes. So, I think that one of the challenges of clinical trials is that the protocols are not maybe always — though that’s something that we do strive to do — are not always drafted with the comfort and ease of the patient in mind. Now, I will say that’s something that we’ve increasingly worked on, because we really want to make sure that
whatever we’re trialing actually will be able to be used in phase IV real world circumstances. So, it’s to our benefit, you know, in order to ensure ultimate uptick of whatever we’re trialing. We need to make sure that the circumstances in which it’s used are actually amenable to
patients’ everyday lives and clinical experience.
In terms of logistics, which is a matter of — you know, many people of color actually live in areas that are not geographically far from these types of academic centers that often have clinical trials. And as we know, geographic proximity and experiential proximity are not the same. So, even if you live quite close to a place that has a trial and you can technically get there for registration, the question is, is the trial happening or the things you have to do, are they happening at times of day when you can actually go? If you are someone who works a shift job, you may not have the flexibility to step away for a middle-of-the-day appointment. You may not be able to take phone calls from clinical research coordinators during the day. So, what can we do to make clinical trials work for the patients they serve?
One, we need to make sure that protocols are developed keeping in mind the broad array of individuals and the careers that they may have, as well as challenges associated with clinical trial participation, including access to childcare and transportation.
Two, we need to work to make sure that clinical trials are in as many types of hospitals as possible. And that just means not only urban academic centers as well as community hospitals in rural and suburban sites, but also specifically at community hospitals that serve
underrepresented groups. So, in particular, working with sites that may be stationed at hospitals or federally qualified health clinics. Places where you’re more likely to see individuals for whom those represent the true kind of primary care home sites of trust as opposed to the academic center at which those trials might originate from.
So, with regards to logistics, we need to think about timing, we need to think about access, and we need to think about making, again, geographic proximity translate into experiential proximity.
Jamie DePolo: Okay. Now, these next few they kind of go together, in a sense: financial cost of being in a trial as well as insurance issues. Because I know some people have had trouble, depending on which arm of the trial they were in, was insurance going to pay for that treatment if it was standard of care? Were they going to have to take time off work and not
get reimbursed for being in the trial? Was insurance not going to cover anything? Those also seem to me to be very tough issues to overcome.
Dr. Lola Fayanju: Agreed. And you know, I think one of the things that is really challenging about the finances of healthcare in the United States is, frankly, that we have a lot of hidden costs both in the direct payment for the treatment we receive, but also the costs that are invisible to the health system but that are experienced by the patient, such as, as you said, missed time for work when you have to go to appointments and have procedures and gets labs, et cetera, as well as the costs associated with paying for parking or paying for ad hoc childcare or paying for additional transportation, as well as the costs associated with your driver also missing work.
And so, with regards to clinical trials, we’re trying to strike a balance between providing incentivization that is not potentially exploitative, that is the type of incentive that would encourage someone who has fewer means to potentially engage in something that might be
not optimal for them, it may be riskier than is really ideal, but also addressing needs that I described before. And that is the hidden and known financial costs associated with trial participation. I think increasingly when we budget for trials and we apply for grants for trials, we think very hard about how we can account for these invisible costs. Either providing direct payment to patients to address these costs as part of their participation or providing in-kind resources that minimize the extent to which patients have to pay for these issues themselves.
Jamie DePolo: Okay. And then the last one that I have read about is a lack of diversity among research and clinical professionals. And that’s kind of what you talked about in the beginning: if I don’t see anybody that looks like me running this trial, why would I want to be a part of it?
And I know that this is another one that there's no quick solution there.
Dr. Lola Fayanju: That’s exactly right. So, you know, I think that the issue of diversity amongst research and clinical professionals is an important one. With regards to seeing diversity amongst the people who are consenting you for a trial, I think what we don’t appreciate is that there are many types of individuals who encounter a patient over the course of their
visit to a clinic. There is the front desk staff. There are the medical assistants to get their vitals. There is the nurse who checks them in and goes over their medications. There may be the advanced practice provider who does the initial evaluation, and then also the physician who ultimately provides the counseling and treatment information that can lead to shared decision-making. And there’s also, in people who are potentially eligible for trials, the role of a clinical research coordinator. So, at every step, every single individual in that process
represents a point of access for understanding what kind of clinical trial could be available for a patient.
And so, often there is more diversity amongst front desk staff and medical assistants and nurses as well as, potentially, clinical research coordinators than there is among advanced practice providers and physicians. So, one thing we can do is make sure to engage all of the
individuals along the pathway from check-in to discharge in the process of consenting or making patients aware of clinical trials. One thing you can do is have a universal consent, which is where at the beginning, when someone checks in, someone can say, “You know, we conduct clinical trials, we’re an academic medical center, would you consent to being
approached for a clinical trial if you are deemed to be eligible?” And that person can therefore plant the seed that begins to encourage people to think about whether or not they’d be open to a specific trial or be approached about one.
In addition, we obviously need to work on improving diversity amongst the physicians and investigators who run the trials. And that is something that I know the [National Institutes of Health] is working on actively as well as various professional organizations. I know that the
NCI has actually asked for input from various professional organizations, including one of mine, the Society of Surgical Oncology, as to how to diversify the scientist population, including clinician scientists, and therefore all the people who would be involved in
clinical trial development.
Another thing that could be really important is making sure that the diverse physicians and investigators and clinical research coordinators we do have are actively involved in outreach. Which would mean having them go to churches, go to community events, speak on webinars about what clinical trials involve. We think that if those who are watching see diverse individuals talking about clinical trials and explaining and kind of demystifying what they’re all about, then they might be more likely, again, to both be proactive in seeking out trials and also be receptive to trials when they are introduced to them.
So, there are many ways in which we can address the lack of diversity. One, as I mentioned, by making sure that we have those in the medical force who are more likely to be diverse aware of clinical trials themselves, make them part of the familiarization classes for patients.
Two, making sure that we do work on diversifying the individuals who are involved in clinical trial development, that is investigators and physicians. And then, three, having diverse individuals from all of those ranks be part of outreach efforts to make clinical trials more
transparent and feel more accessible to the community. So, those are all things that we can do to address the diversity issue.
Jamie DePolo: Okay, those all sound hopefully doable. Now, are there other barriers that you’ve identified in your research that we haven’t talked about yet?
Dr. Lola Fayanju: So, one thing that’s actually really important is the role that patient advocates can play in clinical trials. So, several of the oncology cooperative groups around the country have strong and robust patient advocacy groups who attend our meetings, who participate in trial development, who provide feedback on protocols, on assessments of side
effects. And those patient advocates have been an incredibly important part about making clinical trials more patient-centered.
I will say though that the patient advocates tend to be a relatively privileged and well-resourced group, overwhelmingly white, and that’s not surprising because it’s typically an unpaid role where people are taking it upon themselves to fly, in the past, to these cooperative group meetings or log on from home to attend them virtually, to devote time during the day and sometimes on their leisure time to be part of these protocols. And so, cooperate with investigators — that is time that people who are working other jobs often will not have and will not have the resources to attend these meetings. And so, I think one thing
we really need to work on is diversifying the cadre of patient advocates. I think that’s another way in which we can promote diversity in research.
Jamie DePolo: Okay, that makes good sense. Now, do you think one or more of the barriers that we’ve talked about is more powerful in keeping people out of trials? I guess, in other words, if we could fix or overcome one or two of the barriers, would that help a lot?
Dr. Lola Fayanju: I think the most important thing is the kind of tandem issues of awareness of trials both by providers and patients, and earning trustworthiness in the system. You know we, one, need to make patients aware of trials and then, two, need to make them feel that they trust us to participate in them. And I think that those two things together are really important.
The truth of the matter is, as you mentioned early on, many patients are just never approached about trials, and we know that disproportionately people of color are even less likely to be approached. And part of that reflects, often, the bias of clinicians who may assume that adherence might be difficult or that interest in the trial is not there, and that’s something that we really need to address. We need to address why us clinicians advise that someone is “a good trial candidate” and someone else is not. What biases are we bringing to the table when we make those decisions?
I think after that we also need to work with diverse providers to make sure they are as aware of as many trials as possible. I think once we do that, part of what will be involved in earning the trustworthiness of patients will be also using the right kind of language to explain what
trials are. I know that many patients have expressed concern about the process of randomization. Because unfortunately, the word “randomization” has the root “random,” and it makes patients feel like they’re being experimented on rather than being part of an experiment. It makes them feel that you are kind of playing Russian roulette with their life and that there’s no real thoughtfulness being used in deciding to which arm of the trial they might be allotted. And so, one of the things I’d have to work on in terms of working on developing a language for a clinical trial and as well as in communication, verbal communication, is to demystify the randomization process and explain why we engage in randomization.
And the purpose of randomization is not just a, you know, “cover your eyes and see what happens” approach. The reason for randomization is to create balanced groups that are so balanced, that have so much in common, are so similar, that we can isolate the effect of the
intervention in question. The reason we randomize is to make sure that ultimately there’s someone just like you getting the other treatment, and therefore if we see a difference between the two of you we can be fairly sure that difference is because of the intervention we’re testing.
So, I think one of the things we really need to work on is making sure we’re using the right language to counsel patients about what clinical trials involve and that we arm clinicians with that language, so they can also be an effective communicator about clinical trials.
Jamie DePolo: That makes a lot of sense. I do have to say, I’ve read a lot about this issue coming up to this podcast, and it seems like there are a lot of strategies out there, and they’ve been out there for a while, trying to make clinical trials more diverse. But it doesn’t seem like they’re really working, because it seems like this problem has been talked about for a long time — decades. So, I guess I’m wondering what your take is on that, and do you think there are some strategies out there that are working?
Dr. Lola Fayanju: So, I think that we are at a watershed moment in American medicine. You
know, I think that language about health disparities has obviously been around for 20, 30, 40 years. But I would say in the past couple of years in many ways, highlighted by the disproportionate effect the COVID-19 pandemic has had on communities of color, people are now really speaking into common discourse about health disparities, about systemic racism,
and the way in which the latter contributes to the former.
I actually did a search of the New England Journal of Medicine, and prior to about July of 2020, you would’ve been very hard-pressed to ever hear or see the phrase “systemic racism” published in the New England Journal of Medicine. And there has been an exponential uptick in the use of those words in the research that’s being published in one of the premiere journals in the world. And I think it reflects the fact that there now is momentum behind trying to address those barriers that have long existed, but have often been in the shadows.
I think that we’re also going to see the parallel strategies that I’ve discussed finally coming together to help each other in a way that is synergistic. You know, we are gradually making more progress in diversifying the healthcare workers. As I said, we are gradually naming
systemic bias and trying to address that not just in the individuals, but in the system. How are there ways in which we’re perpetuating who gets excluded from certain types of clinical care and clinical opportunity? We are actively thinking now about how to diversify patient advocates, how to make clinical trials more patient-centered. And there are successful programs such as Just Ask, which is a program that was launched at Duke, my former institution, under the leadership of Nadine Barrett, who is a medical sociologist and a professor at Duke who has worked on a program that really brings clinical trials to the patients and to the people. Allowing for greater outreach information provided to community members about clinical trials and developing literature that is very palatable to different diverse types of individuals.
So, I think Dr. Barrett’s program is one that really represents success and has really helped improve clinical trial involvement in the Duke Health system and is an example of how that can be done at other academic sites. But again, I think that we’re in an important moment in
healthcare where there is enough interest and enough parallel strategies happening that I hope that we will see significant change in the next decade.
Jamie DePolo: Okay. Now, you conduct clinical trials, so as a final question I’d like to ask you how you talk to your patients about clinical trials? You very eloquently talked about the word "randomization" and how that can be a problem. Are there other things that you think need to be explained better to patients, or I guess I’m just wondering, how do you approach your patients about clinical trials?
Dr. Lola Fayanju: So, in addition to the language about randomization that I used earlier, I also try to explain to patients what the purpose of trials is. That is, we come into trials at equipoise, which means that we have a suspicion, we have a hope, a hypothesis that there is an alternative that is better than what we currently have right now, but we don’t know that. And if we absolutely knew that, we wouldn’t need to do a trial. And so I really have to emphasize to patients that they are contributing to the larger good by participating in clinical trials. That they are making it more likely that women or men like them, people who are
children now or have yet to be born, will benefit from their participation. So, I emphasize, one, you know I explain equipoise, I explain what their contribution is. I do try and emphasize that this is not an opportunity that historically has been made available or was afforded people of color and that we can change that. We can make trials work better for us going forward.
There’s that, there’s language and randomization. And then I speak quite candidly about helping them personify who is good for that trial and whether, if I had their condition or my mother had that condition, I would feel comfortable participating in the trial and having my mother participate in the trial. And I speak very honestly about that. I also do engage diverse personnel to talk with patients about trials. I have had the privilege of working with excellent clinical research coordinators who are able to speak a language that patients understand. And I will often have them do part of the counseling, because I think that they can have a huge impact in helping patients understand trials and ultimately agree to be part of them. One thing I also advise the patients is that you have the opportunity to walk away at any time and
also that many trials have an opportunity for different levels of engagement.
So, there are patients who say, “Well, how does one randomize something that I absolutely do not want to do?” I always tell them, “Look, you have the opportunity to walk away at any time. This is not a jail sentence, and we don’t want it to be. We want active and committed
participation, and if you choose to walk away there are other ways in which you can still contribute. We may still track you. We may still send you questionnaires. That, too, will contribute to science.” And so, I emphasize that there are ways in which to be more or less involved in trials and that there’s always the option to walk away. Empowering people to know that there is choice at any time in the process has also been very important and something I really emphasize.
Jamie DePolo: Oh, that’s all very, very good information. Dr. Fayanju, thank you so much. This has been really, really helpful, and I hope it opens a lot of people’s eyes to the value of being in a clinical trial.
Dr. Lola Fayanju: Thank you so much.