Diversity in Clinical Trials: How Sponsors Can Help Close the Gap

Hi, everyone. My name is Cassandra Smith. I am the director of diversity and inclusion and trials for Janssen, and I'm honored and very privileged to lead the efforts. There are so many different lenses you could apply to diversity and inclusion.

In trials where we're starting is focusing on racial and ethnic diversity. I cannot stress enough how important intentional selection is to achieving diversity and inclusion in clinical trials, and so we'll talk through that throughout the presentation. So before we do that, I wanted to start with three things that I wanted to point out here that are considerations that typically drive down the volume of underrepresented or minority populations in trials. Access to care and competing demands cannot be underestimated.

Access is a really big barrier. People can't participate where they don't have access. And so from a industry perspective, we need to ensure that we're increasing access. Now, if you were to split access, there are a lot of different levels and layers to that as well.

But one thing that is pretty low hanging fruit that we're focusing our discussion on today is site selection and engaging the right sites to therefore provide additional access. Competing demands is really speaking more to some of the lifestyle factors and socioeconomic challenges that underrepresented groups may face. There are some things that we can do through the sites and clinical development operational practices to help with access. So a great example here is something like if you're dealing with a population.

And it's a working population, it may not be as easy for them to take off work or, you know, have vacation time to enroll into your study and participate might you consider as a site, you know, extending your hours or having some flexibility, that all really leads up to the access. The next thing that I wanted to address is the language and literacy barrier that we find sometimes in diverse populations. So language is key. You can't take away a person's ability to communicate.

And I think oftentimes we think about in terms of, you know, native tongue, english, Spanish or Russian, whatever that language is. But literacy also really feeds into this conversation because we can't assume that everybody has a high degree of health literacy in clinical research. We're talking about very complex science and, you know, operational concepts that people have difficulty understanding. And so we have to keep that lens, especially if we're talking about trying to enroll diverse populations where there are some known a lower literacy generally and specifically for health literacy.

So two really important areas as well that are considerations that again, sites certainly can help us sponsor, certainly can help with. And then the last one is around mistrust and misinformation. I would even maybe take it that next step further about clinical research or in clinical research, in health care and in the pharmacy industry, in society. I think that this also can't be underestimated.

But through engaging with the right sites and the right community organizations and maybe community ecosystems, mistrust is something that we can chip away at. There's a lot that we can discuss through each of these, you know, different considerations. But I'm going to focus on that. The chase for access, really, because that really ties into a nice conversation around, you know, access as related to asset selection.

I wanted to share a bit of data. And this is from our friends at Tufts. It's a look at underrepresentation in clinical trials and again, focusing on racial and ethnic minorities, and where do we stand as an industry? What does this actually look like?

And so you can look at the data here. It really speaks for itself. Black or African descent participants made up 5.4% Asian participants made up 8 8.6%

Hispanic, Latino 7.2. And then other race categories such as alaskan, native American, Indian, et cetera made up 3% So if you total all of that, that only comes to just under 25% of participants being, you know, racial or ethnic minorities. So the question is, which I think it's an obvious answer, what about the other, you know, essentially 75% that was made up of white participants. And so you can see it's not leveled up quite well.

And if we look through the next two columns disparity and number of therapeutic areas, what this is telling us is that, OK, they adjusted essentially for prevalence of disease in these particular populations to understand what does the disparity really look like? Because the column around trial, participation and isolation, it tells a piece of the story. But I think you really do need to layer on, well, what is the prevalence of, you know, disease burden in these groups? And given that, do the numbers improve or are they are they were?

So what does it look like? And so the middle column, looking across 18 therapeutic areas, you can see that the Black and African descent population was really underrepresented in. Local research by close to 54% That's huge. Looking the next level down for the Asian population, there's an over index of 118% So that's great to see that there's a healthy dose of participation in the Asian population.

But, you know, again, it's both kind of back down to a more grim story for the Hispanic Latino and then, you know, kind of the other category. We have some room and opportunity really to make improvements. And again, going back to the theme of our talk today around access, I think there's a really, you know, unique opportunity that we can push this along and really get some better, you know, improvement in the data. What role can sponsors play in this?

There's a lot that we can do. There are absolutely some things that we as sponsors cannot do or that it's very challenging. But there is still such a rich opportunity for us as sponsors to change the way we approach clinical development, the sites we select, how we interact, and really are we making diversity and inclusion and trials a priority? And so I just have here a few items that, you know, we can think about from a sponsor perspective and examine our remaining into this is their opportunity.

So they start with some of the things that are, I think, easiest are up to some of the more difficult or involved, I guess I'll say entities. So the first one around meeting patients where they are. So this again this is pretty simple that we can take data driven approaches to understand where patient burden is and we can start to look for sites in those areas. That's not always how industry has worked.

I know that there's a big move, you know, throughout our industry for data science and really taking more data driven decisions as it relates to site selection. So this is one that if we apply the diversity lens on what we're already doing around data driven decisions for site selection, it could be very powerful. Going another step further forward is connecting with community health care professionals, and this is something that we as sponsors can do directly. We could also engage with trial sites that have existing relationships or are willing to build relationships with other community health care professionals.

I think this is a really important one because there's a whole ecosystem of health care that people that patients navigate through. And it may not necessarily start or end really with the trial physician. So if the patient has an existing relationship with their community, health care professional, their general professional, maybe even their specialist, but it's somebody they know that they're familiar with. Imagine if we were to leverage, you know, those relationships to trial sites that are experienced that, you know, we do typically go to for our research and how powerful that connection could be, where patients now feel more comfortable because they know that the recommendation of referral is coming from a source that they're familiar with the next one, which again is an increasingly more difficult.

And what I mean by this is, you know, industry sometimes we know the sites that we know and we go to the sites that we go to. I think our lens of, you know, data science and applying that to site selection will greatly help here. But still, I think we should be intentional about finding sites that maybe we don't know, but who are out there and really ready to participate in research. So I'm not speaking about inexperienced sites in this particular case.

I'm really talking more about just the sites that we don't know. And therefore, you know, because we don't know them, we don't choose them. We have to change that thinking. And then finally and this is a heavier lift, I fully recognize it and understand that is so we talked about expanding the site pool, but is there opportunity for us, for us to actually help grow the site pool?

And this is where I'm speaking more about the usage of novel health care professionals to gain experience. Are there opportunities where, you know, we can partner up with health care professionals that have an interest in research, maybe don't have the infrastructure or know how to become sites, but with some help and guidance from us and from other colleagues that maybe are more experienced that we work with, we then, you know, kind of grow the number of sites that have access to the patients we're looking for research.