Garth Sundem   00:00

Welcome to this episode of the Medical Affairs Professional Society podcast series: “Elevate”. I’m your host, Garth Sundem, Communications Director at MAPS. And today we’re speaking about Augmenting Diversity in Clinical Trials with Stacey Rivkin, Vice President of Client Solutions and Strategy at H1. This episode is sponsored by H1, whose platform helps life sciences companies, hospitals, academic medical centers and health systems, connect with providers, find clinical research, locate industry experts, and benchmark their organizations. So, Stacey, Medical Affairs teams help to optimize the use of new drugs in the real world. But clinical trials don’t always represent the real-world, do they?

Stacey Rivkin   00:53

No, not always.

Garth Sundem   00:56

And so, let’s, let’s talk about that. So why do what why do we lack diversity in clinical trials? And what is the danger in not representing the population? You know, fully in clinical trials?

Stacey Rivkin   01:13

I mean, I think that’s such a huge question, right? There’s so many different aspects of why, right, of why clinical trials have traditionally lacked diversity, there’s historical barriers, there have been access barriers, there are awareness barriers and prioritization barriers that the pharmaceutical companies haven’t necessarily always acknowledge. One of the I think one of the impacts of the FDA’s new guidance on requiring diversity in clinical trials is what’s really finally, bringing this to the forefront. People have known this has been an issue for a long time. But it took the FDA guidance to really make the industry act more than anything.

Garth Sundem   02:05

Okay. And so why does the FDA require diversity in clinical trials? What is the need for diversity in clinical trials?

Stacey Rivkin   02:12

Well, I think everybody can understand that if we want to be able to have the right treatments go to patients, we need to make sure that we’re studying them within those patient populations, the opportunities to get patients into clinical trials is always vast. And in all honesty, there are places and organizations that are just completely dedicated to running clinical trials, who can recruit quickly, and, you know, really get you those patients that you need. But that doesn’t mean they’re getting you the right patients. And what are the implications after that, if we don’t get the right patients into trials, we know what the FDA might say. But even if we were able to get previously through the barrier of the FDA, it still left us with the barrier of the providers and the patients, right? Providers were like, well, I don’t see my patient population represented in the studies that you did. And so, it’s going to be harder for me to understand what the, what the efficacy of these treatments could be or what the side effects could be within those patient populations. There’s so many different problems we have, you know, I’ve experienced with, when one of the companies that I was working with, that really conducted most of their trials outside the United States, and that was a huge impact on them when they went to market in the US, not just because of diversity, but also because of experience. If you don’t have the right patients, and you don’t have the right providers, you’re not going to get those experienced providers who can really understand how your treatment’s going to affect their patient population.

Garth Sundem   03:59

Well, so is diversity in clinical trials, mostly to provide peace of mind and training and understanding to providers? Or do we really see differences in efficacy across geographies and across populations?

Stacey Rivkin   04:21

I think that’s a really great question. It’s so hard to know before you’re going into a, trial, right? We know that there are definitely differences based on different populations and how their disease progresses. Right? That’s those are established epidemiological science that we have in a variety of diseases, whether it’s gender-based or race-based or age-based, there’s definitely a lot of information that we know is going to impact those patient populations. And, you know, the FDA makes, the FDA makes calculated decisions right, based on what it understands the benefits and risk ratios always are, and they want to have the most information. And in turn, you know, going back to what you first said, we want to have the most information in Medical Affairs as a pharmaceutical company, we want to make sure that we can take that information and share it with providers that actually informs their treatment decisions.

Garth Sundem   05:26

Well, and so is the traditional model that, you know, you have your study inclusion criteria, and they’re very narrow, and you’re looking for the drugs signal, and this is your best way to get it. And then you get your approval and you take your drug out into the real world. And then hasn’t it been the role of Medical Affairs to look at how that drug works with expanded patient populations? Sort of in that setting? Is it just that we’re trying to move up to the RCT? You know, so that we said that we know about efficacy across populations earlier?

Stacey Rivkin   06:03

I don’t think that that’s, you know, I think if that was the only reason it wouldn’t be as compelling as it is right now, where we understand that there are so many different things we’re looking for when we’re trying to kind of go into a clinical trial, right, we want to find motivated investigators who have the right patient populations, who can work with us when we get to market to help amplify our outreach. Right? And so, all of those factors really mean selecting the right providers, selecting the right investigators and the right patient population. I think that the FDA recognized that there was both a gap in the trial population, which could affect the downstream understanding of efficacy and side effects. And understood that we’re not serving medicine, well, if we’re not testing and trialing with the right patients.

Garth Sundem   07:06

Okay. So now, I mean, so that’s the background, there is a need for diversity in clinical trials. And a lot of times, it’s hard to get. So how do we get it? And, you know, you talked about all of these factors that have historically led to lack of diversity in clinical trials. Do we need to work on each of those piecemeal or? Or is there another solution to diversity in clinical trials?

Stacey Rivkin   07:35

It’s so gratifying, I guess, that it’s been brought to the forefront and that everybody is addressing it. There’s been a huge effort in every area in both, you know, in the pharmaceutical world and the patient advocacy world to really start to amplify these messages. But I think that if we think about how we’re going to find the right people, and how we’re going to find the right patients, there’s so many different ways. There’s definitely a Venn diagram, right? There’s a Venn diagram that gives you your sweet spot, there always is a Venn diagram in you know, strategy. But you know, you’re looking for that sweet spot you want to find, obviously, you want to find the right patient population. So, you need to understand where those patients are, you want to find providers who have the patients that you’re looking for who maybe or maybe not match the patient, match that criteria that you’re looking for. So, are they you know, are they part of the same patient population you’re trying to inform and recruit from, but also, you have to make sure that you’ve got people who care about these things. There are tons of investigators out there who have not made this a personal priority, right? And there are, there are people out there who are talking about this. So, where does that Venn diagram really connect? Where do you find those motivated investigators who understand that disparities and equity are important to, are an important factor we need to be talking about more medicine. So, you’ve got a whole academic approach of people who care about things like that, you’ve got a whole patient centered approach about where are those patients. And then finally, it’s about who are the people who can help amplify those messages to the right populations. And so, that Venn diagram, you know, it may have three circles, it may have four or five, but making sure that you can kind of look for that sweet spot is going to really help enhance your efforts in recruiting a diverse trial.

Garth Sundem   09:44

Oh, I love, I love looking at that as a Venn diagram, because you could add in additional factors, which would be another bubble in your Venn diagram. And then all of a sudden, you know, I imagine you’re getting smaller and smaller areas of overlap. But you’re also drilling down on, so sorry, are you drilling down on providers at that point? Or are you drilling down? Not on patient advocacy groups, or patients? Or, you know, who are you? Who are you finding? What is our way in here?

Stacey Rivkin   10:19

Right? It’s such a, it’s such an interesting funnel question like, do you start with people who care? Do you start with people who have clinical experience? And you can approach, and like you said, the bubbles? I mean, I can think of three, four, maybe even five different bubbles, and we’re not going to get that, you know, small little pinpoint in the middle, but where can we find the intersections? Right? Where can we find those people who have experience in clinical trials and have the right patient population? That’s, you know, that’s a starting point that we haven’t necessarily considered usually, we start with the experience and clinical trials, and never necessarily ask the follow up question to do they have a diverse population. But even if they have a diverse population, do they care enough to want to make sure they’re recruiting within that diverse population? So, we can bundle it in so many different ways.

Garth Sundem   11:18

Well, that seems tricky. You know, I can, I can imagine finding the people who’ve published or people who’ve been trialists, and, you know, maybe then filtering for the people who are likely working with a diverse population, but how do you figure out who cares?

Stacey Rivkin   11:34

That’s a great question. There are so many different ways right now we can look at people who are publishing on healthcare disparities, who are talking about, you know, healthcare equity, who are part of organizations that are speaking about these things, you really, you know, I always love when I was involved in putting together the PIs for a trial and that push and pull between clinical development and clinical operations and the Medical Affairs teams, right? There’s a, there’s a natural tension that exists there where the clinical development and operations team, they know their objectives, right? They’re looking for people, you know, they’re looking for places that have central IRBs that can recruit quickly have experience, right? They’ve got, you know, and that’s the extreme right? They’re kind of focused on how fast can we get this trial done. And the Medical Affairs team is really focused on who are the people I want to be involved in this trial. And so, what we really need to do is make sure that we’re balancing those two objectives, right, and making sure that both hands understand the priorities of the other, and why they matter. Right, so that the Medical Affairs team really understands that where the clinical development and operations team is coming from when they talk about central IRBs, and how much experience these investigators have or if they’ve worked with them before, and things like that. And the operations team needs to understand why it matters to have people who care in these clinical trials, even if they might not be the best recruiters, even if they might not have the patient population, or you know, exactly match what you’re looking for, because they’re going to be able to provide an amplification to the right people that you need to have. So, it’s a partnership there between both people who are prioritizing diversity, those people who are publishing on it speaking on platforms about it, those people who are part of organizations that focus on it, and finding those people is as important as finding people who have central IRBs and can recruit quickly, right, like that balance has to be on both sides of the Medical Affairs organization.

Garth Sundem   14:09

Well, so, in terms of clinical development, and operations, is it that they tend to look at things through a quantitative lens, they’re seeing where they’re going to get the most patients quickly and be able to get trial results, right. And, you know, Medical Affairs can bring a more qualitative influence and say, you know, here’s why. Here’s, here’s the, the, here’s people who care, you know, and sort of look at the quality of a trial rather than the quantity of a trial.

Stacey Rivkin   14:51

I think it’s, you know, if we think that where we’re looking at, including diversity and inclusion as part of a trial, we’re really trying to be much more patient-centric. And I think that that’s where both parties really need to meet in the middle. It’s, you know, that quantitative approach that the clinical development and operations team is going to take. And that qualitative approach that the Medical Affairs team is looking for really meets in the middle with patient centricity. It’s really about those patients and both teams have a vested interest in making sure that the trial is successful and successful has to be measured on a lot of different metrics. One of my experiences was post-trial, right, I was involved in a, in the launch of a product that had just finished a trial and having not had been involved eight years earlier when the trial started and when PIs were recruited, I was asked to start searching through the PI list for people who would make good speakers, people who could, who were trialists who could then be people who were either going to speak on behalf of us in disease awareness programs are who were going to be part of our speaker’s bureau. And, unfortunately, they were much fewer and further between than I expected to find. And so, I think when we talk about the successful execution of a trial, we need to think about all of those factors. To me, where diversity fits in there is that if we don’t have the right providers, who can talk to those patient populations involved in those trials early on, we’re going to be losing out on the other side, once we get to market to start to really have those patients have trusted advocates who can speak to the benefits and efficacy of the, of these products. So, a lot of you know what, I hate to kind of look at it as a quantitative or qualitative approach. But it’s really about defining the expectations of a successful trial. And so long, diversity wasn’t included in that definition. And now that it is, we’re seeing all of the benefits that can be had downstream, as well as obviously, the benefits to the right patients who are going to benefit from the, from the treatments.

Garth Sundem   17:34

And you’re not talking about layering diversity on to an approved product. You know, later, you’re talking about Medical Affairs involvement in designing trials for diversity very early. I mean, it would have been better if you had been eight years earlier in choosing the PIs. So, is that an adjustment for a lot of Medical Affairs teams and being involved much earlier in the development process?

Stacey Rivkin   18:01

I definitely think it is, there’s always been, in my experience, an opportunity for Medical Affairs teams to nominate PIs that participate in trials. But I think that the lens has been focused on maybe one or two areas, maybe it’s been focused on expertise, maybe it’s been focused on relationships, and where we knew we had opportunity for people to be incorporated into our programs. But it was never holistically approached from a strategic perspective of how do we use the information that we have to identify people who are going to have bigger impacts on our trials later on? How can we find people who serve those populations? Because we know that when we come to market, we’re going to need to talk to those populations? How do we find people that care about the diversity and the impact that it has on underserved populations, because we know that they’re going to be important when we talk to the FDA? All of those things, you know, too often we start clinical development. And we think of things like Medical Affairs gets involved when we get to phase three, when really we need to be, you know, getting involved in phase two in earlier on to really make sure we’re a part of those discussions, where we know the priorities are going to be for the organization when we come to launch.

Garth Sundem   19:39

Well, and you’re talking about a holistic view of involving people in clinical trial diversity, and you’re not just talking about getting diverse patients into earlier clinical trials. You’re actually talking about stakeholder engagement and creating advocates within the health care community who are, who are also going to be communicating your message of diversity moving forward. So, communication seems like a big piece of this puzzle as well.

Stacey Rivkin   20:19

I definitely think it is there are, there are easy opportunities to find people who are passionate about these issues. Right? And maybe they’ve never even considered being a part of clinical trials before. Maybe that hasn’t been their focus, can we work with them to show them what some of the value of being a part of this clinical trial might be? And on the other side, can we use people who care to impact and influence the people who are PIs in our trials? So, if you do have the right patient population, how do we talk to you and make you and help you understand why this matters? Why it matters more? Right? So, there are so many, you know, whether we’re talking about Southeast Asians, whether we’re talking about black, whether we’re talking about you know, gender or age, right, all the different diversity signals that we’re looking for. Finding those providers, you know, it’s always going to be about finding that intersection. And when they don’t intersect, can we find networks? Can we find ways of impacting networks? I loved, one of my favorite programs that one of my teams ran was a trial awareness program, right, where they would have a PI invite their networks in and talk about the trial so that they could help recruit or maybe even refer patients to the PI for that trial. But the concept of understanding provider networks is really so much more than that. I think, when you only think about it in terms of a recruitment strategy, you’re missing the mark, right? You need to think about it in terms of a communication strategy, you need to think about it in terms of a diversity strategy, maybe even a digital strategy, right? Understanding what those, understanding what those networks look like. There’s, whenever we talk about and think about things in a silo, we miss out on bigger opportunities. And so, my, you know, my favorite thing about information is how you can make those connections right, you can understand somebody not only as a investigator, not only as an expert, not only as a provider who has the right patience, but where you can start to make those connections.

Garth Sundem   22:50

It’s interesting that, it’s interesting that you, you know, the mechanics is to drill down to an ever-narrowing overlap in this Venn diagram. But the goal almost is to expand the takeaways of a trial to be more universal, to cover more people in understanding that is generated by the, by the clinical trial and make it an applicable to all populations by drilling down, which seems a little counterintuitive. But Stacey, I think we need to leave it there for today. And I’m glad you brought up these networks and digital and aligning with strategy because now we have our next five podcast episodes. But thank you very much for joining us today. And to learn more about how your organization can partner with H1 to unlock key insights and opportunities for industry engagement to create a healthier future, visit H1.co.  MAPS Members don’t forget to subscribe. And we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series: “Elevate”.