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Minority representation in clinical trials [PODCAST]

The Podcast by KevinMD
Podcast
June 25, 2024
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Subscribe to The Podcast by KevinMD. Watch on YouTube. Catch up on old episodes!

Join Ananth Ravi, a health care executive dedicated to democratizing health care through innovative image-guided therapeutics. In this episode, we delve into the persistent issue of racial disparities in breast cancer outcomes, exploring how women of color are disproportionately affected by later-stage diagnoses and poorer prognoses. Ananth shares his research on the role of clinical trials in addressing these disparities and the importance of minority representation. We discuss strategies to improve trust in the medical community, the challenges of increasing trial participation among Hispanic Americans, and the need for large-scale efforts to understand and eliminate health care inequities.

Ananth Ravi is a health care executive.

He discusses the KevinMD article, “Why minorities need more representation in breast cancer research.”

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast, and get CME for this episode by clicking on the CME link in the show notes. Today we welcome Ananth Ravi. He’s a health care executive, and today’s KevinMD article is “Why minorities need more representation in breast cancer research.” Ananth, welcome to the show.

Ananth Ravi: Thank you very much, thanks for having me.

Kevin Pho: So let’s start by briefly sharing your story and journey.

Ananth Ravi: Sure. I’m a medical physicist by trade. I started my career in the radiation oncology space, really taking care of patients and innovating in that space. And one of my principal ideas kind of became very attractive outside the health care institution that I worked at, at Sunnybrook Hospital in Toronto, Ontario. And we decided to go ahead and commercialize, and very recently have now expanded across the globe. And our whole premise is to democratize care and improve the patient experience of breast conserving surgery.

So yeah, I think that’s where it starts. And as a background, I’ve kind of had evolutions where I grew up in Africa, then came to Canada as an immigrant, and have kind of evolved in that I’ve seen multiple health care systems. So very topical in terms of my interest of what we’re talking about today.

Kevin Pho: All right. So in your article you mentioned that term, democratized care. So what exactly does that mean to you?

Ananth Ravi: Yeah, and that stems from just an early experience with access. I grew up in Africa, at the time I had one of my best friends succumb to cancer, and my grandmother, in short order. And it was very apparent, even at that young age, that had we lived somewhere else there would have been better access to facilities and more cutting edge health care.

And that access is restricted by a lot of factors, primarily socioeconomic status and where you live. And that is within the US and Canada, but also applies globally now that we have a global scope, and I see how care is delivered in various countries. And it can’t be more real now. So I think that’s how it was influenced, and it’s about really just making sure that we can make access equitable around the world.

Kevin Pho: All right. So in your KevinMD article you expand on that theme, increasing that net for clinical research. Your KevinMD article is titled “Why minorities need more representation in breast cancer research.” For those who didn’t get a chance to read your article, tell us what it’s about.

Ananth Ravi: This was stemming from early on, I was doing a lot of research in the breast cancer space before we started to commercialize MOLLI. And we were also guilty of it at the time. Granted, we lived in Toronto and we have a very diverse diaspora of patients, however we weren’t paying attention when we were recruiting on clinical trials and ensuring that we cover the spectrum of patients we see.

And so the big impetus was where we noticed that 40 percent of the US population is a visible minority, but their representation in trials is on the order of 10 percent. So really our trial data is not representative of the patients that we treat.

And there are now profound implications of that, where we see that while breast cancer deaths for white women in the US are decreasing in all 50 states, for African American women it increased in a couple of states, and they were kind of flat in 24, and only decreased in 11 of the states.

So there is, because we’re not actually factoring them into how we study and research breast cancer care and therapies, I think we’re missing a lot of knowledge. And in the article we talk about, perhaps, we don’t pretend that there are definitive solutions, but perhaps there’s a little bit more thought required on how we tackle this much larger problem.

Kevin Pho: So what are some of the reasons why there is a disproportionately less inclusion of minorities in these cancer trials?

Ananth Ravi: It’s multifactorial, and then it comes down to a number of factors. I mean, there is generally cultural sensitivities and socioeconomic sensitivities around this, and typically patient education and outreach are done through mediums that might not even be talking to the patient populations that are being underserved at the moment.

And so making sure that the outreach and education are culturally sensitive and contextual is paramount. And I think we’ve historically not done a good job of that. There’s been really no patient navigation that’s dedicated to the 40 percent, if you will.

And I think people are now paying attention, and I’m hopeful that there are now strategies, and in granting agencies they ask you these questions and force you to look at these parameters. But I think generally everybody’s pretty aware and are trying to do better. So I’m very encouraged as of where we’re headed, but it’s useful to understand where we were, and there’s a lot of work to be done.

Kevin Pho: And in terms of that disproportionately less inclusion of minorities, does that cut across the majority of cancer research that you’re seeing, whether it’s chemotherapeutics, whether it’s surgical treatments or procedural treatments? Is it pretty much the same across the board?

Ananth Ravi: It’s the same across the board. I mean, if you think about the propensity of triple-negative disease for Black women is much higher than it is for the rest of the population, but because they’re not enrolling in studies, our knowledge and the treatment options for this type of disease is, I would argue, less than for the others that have been much more comprehensively studied.

So there is a huge opportunity to do better in this field. And I think one is just awareness, and starting to measure and understand how far off we are, and then having targeted strategies to try and improve this paucity of information.

Kevin Pho: So talk more about how patients are recruited for these studies, and the barriers that may be obstacles for them to participate.

Ananth Ravi: Yeah. I’ll talk historically. Patients will come to your facility and you approach them with, there’s an available open trial, and you ask for the consent to join a study. And it’s just kind of chronological, whoever walks through the door that’s eligible and meets the criteria of the study is offered, and if they accept they go on trial.

Historically, different communities are distrusting of clinical studies and testing on patients, and so there’s a little bit of stigma around clinical trials being like, you’re just experimenting on people. And different communities look at that separately, and partly because patient awareness and patient education campaigns have really not targeted some of these visible minorities. So you find there’s a level of distrust. So that’s the one part, when you approach for consent.

Another historical piece was, there was inadequate translation. Just simple things like language was a huge barrier, to get consent, being able to speak in the patient’s local dialect so they fully comprehend the value of joining a clinical trial.

And then you mentioned this, the economic impact. I mean, cancer care in general is financially burdensome already, but to be on a trial, it requires multiple visits and appointments. And it’s a study, and there may be multiple time points that they have to be engaged, to really understand what the impact of a therapy or some monitoring or whatever the test may be, or hypothesis that’s being evaluated. And that is problematic for those that need to be at work and have a family to support. To take time off to do something is incredibly restrictive.

And so those are the historical challenges that we faced, where these populations just would never have access to clinical trials. And my hope is now, as we kind of are aware of the challenges, that we have strategies that target these various issues. And I know for a fact that there are now translators available that are culturally sensitive. There is, I think, a lot more that needs to be done in building trust in what clinical trials are and what they’re meant to do in terms of addressing the needs of these populations. And then finally, I think there has to be strategies for those that are financially impacted by clinical trials, making it a non-factor, so that they can participate without fear of putting food on the table.

Kevin Pho: In your article you cited a couple of studies, one from Duke University, one from the University of Illinois, that highlighted a success of targeted programs. So briefly talk about that approach, and what kind of lessons can we take from those studies to apply more broadly?

Ananth Ravi: Yeah, and I think these targeted strategies are really around focusing on the patient population, the specific needs and the cultural sensitivities of the patients that you want to recruit. And these studies were very, very effective in making sure they had representation that was accepted by the communities that they were trying to enroll in their studies.

And I think that is by far the biggest component, because then you fully understand what the limitations are, what are the trust issues that are available, and are able to provide education tools that are relevant versus kind of what we think should be appropriate, and they really miss the mark.

And they found that both studies were incredibly effective at increasing recruitment. So even socioeconomic populations that were depressed were still enrolling at high numbers with some of the strategies that they deployed.

Kevin Pho: And in terms of deploying these targeted strategies, why aren’t more clinical investigators using these targeted strategies? Is it a time issue, is it a cost issue? What are some of the barriers that prevent more widespread adoption?

Ananth Ravi: I think a lot of it is, and this is where the hope comes in part, we’re in a period of transition, where we used to do these in a big way, there was not a lot of focus. There’s been a lot of attention placed on how little we know and how kind of uneven and unbalanced our research evidence base is, or our clinical evidence base is.

So now that we’re working towards it, I think it’s a matter of time before everybody starts to consider these strategies and deploys them. So that’s the hopeful side of things, and that we are actively right now in this transitionary period.

But yeah, a lot of it comes from, I think even from the clinician side, a little bit of unawareness that this is a challenge, and we do need to factor these things in how we, and even when we look at clinical data from these massive trials, there is now a piece where you think, does this truly apply to my patient if they are in a minority that’s not represented in the actual demographics of the study? That is an important question that we need to be asking.

Kevin Pho: So let’s talk about paths forward. What do you see in the foreseeable future when it comes to enrolling more subjects in clinical trials? What do you see as some trends that we could look forward to?

Ananth Ravi: So I think a lot of trends that would be, and certain trends that are happening already, is kind of regionalization, and having patient navigators that are able to speak to the context of the individual, so that they understand their concerns and are able to adequately respond, in the sense that, if the concerns are legitimate, so forth. But at least it’s an informed decision, versus, we just haven’t in the past been able to communicate effectively.

So I think that is going to be a dramatic improvement in terms of clinical trial recruitment, versus, you have your standard clinical trial assistant that goes around and does that. You’ll have much more, you’ll have a team that perhaps on various trials will be deployed depending on the patient that walks through the door, and you’re able to have a really full conversation so that they understand the value of the trial. And in most instances, I know people will participate.

And then the other piece, I think, is just how we structure funds for trials. I do think there will be allocations afforded such that socioeconomic status and funding and some level of remuneration is available, to make it so that it’s not as burdensome.

And I think if those two things are kind of implemented on a broader scale, we’ll see representative inclusion on trials. So I’d love to at some point in the future see 40 percent of all trial populations are represented by visible minorities, and we have a really nice representative mix of the patients that we serve in each region.

Kevin Pho: We’re talking to Ananth Ravi. He’s a health care executive. Today’s KevinMD article is “Why minorities need more representation in breast cancer research.” Ananth, we’ll end with some of your take-home messages that you want to leave with the KevinMD audience.

Ananth Ravi: Yeah, I think my take-home message really comes around, we’re in this period of transition, and that people should be aware that historically all of our trial data did not necessarily focus on these demographic measures. And as we move forward, it’s incumbent on the clinical community to do better and pay attention to these, and I know everyone is.

And publicize the strategies that work, because I think people are asking these questions, and even I’m trying to struggle with them. There are some that have worked, and publicizing what works will allow us to incorporate best practice as we kind of evolve through this transitionary phase.

Kevin Pho: Thank you so much for sharing your perspective and insight, and thanks again for coming on the show.

Ananth Ravi: All right, thank you so much.

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