Increasing Diversity with the Integrated Research Model

ACT: What do you think are currently industry's greatest obstacles in achieving more diversity in trials?

Moultrie: I would say, one, being access. I think we have lots and lots of opportunities across our industry, but they're concentrated in pretty specific areas, and have been for a while. I think if we can solve the access problem, we would be doing a great service. I think one of the other things that once we—if and when we—get past the access problem, it's this idea of what I consider clinical trial education and awareness. We can have all the trials in all of the places, but if folks don't really understand the process—I'm a big proponent for informed consent can't start a screening visit. We have trials in all of the places. How are we making sure folks understand what they're really signing up for and what they're volunteering to do? I think one of the biggest ways we can combat that is through community engagement, education, awareness, and making sure once we've solved for access and we've got plenty of opportunities in lots of places, we also have folks who are ready to make informed decisions. So, making sure that we are out and engaging in communities and with potential patients and families of potential patients significantly early in the process and not waiting until we have a trial to start having those engagement conversations.

ACT: Can you explain the model of integrated research organizations (IROs)? How can they help increase diversity in trials?

Moultrie: The idea of the IRO is making sure that folks can get access to clinical trial opportunities where they're already receiving care. An IRO, like Javara—our entire goal is to essentially be the research infrastructure for a practicing physician, and in that way, our teams fully integrate within the practice or hospital setting—wherever the physician may be. We integrate into systems, so we become a part of the physician’s care team. I joke a lot when I worked in the clinic that sometimes folks didn't know if I was a Javara person, or if I worked Dr. ‘so and so.’ We do that very intentionally because we want folks to feel like we're an extension of their care, and not this, mystery piece and mystery folks who are just coming in to do this thing. I think our integration in that way, it sustains our longevity within the practices and institutions where we partner, and it gives potential patients and existing patients an opportunity to see it like that—we're committed, we're seeing this entire thing through. I think that's the biggest differentiator. People can get care where they're already going. They can get clinical trials where they're already receiving care, and they get that continuum of care with their care teams. We're an extension of that team.

I've had patients in my career—one of my favorites is that my patient said that they were only going to do it if they can see their usual phlebotomist, because they've been going to that practice for 20 years, and that's the one person who can do it right, and get it done quickly. Being integrated in that way allows us to give patients that flexibility. We make sure the entire care team is on board and they're aware of what's happening. Now, everyone can't do all of the things, but there's a level of familiarity there that I think makes patients much more comfortable in participating. One of the hurdles that I didn't mention earlier, as far as participation in clinical trials for marginalized communities is that there's a level of distrust with the health system as a whole, not necessarily just clinical research, but if I get to have my usual physician provide insights and suggest opportunities, for me, I am much more likely to trust them versus someone who I've never seen before—cold calls, and while I do understand in some places, cold call works, but when we're already fighting an uphill battle of improving and trying to turn the tide of our industry, it sort of missteps. Having that trusted partner, I think, is key in helping move some of that forward, because patients are there, relying on those physicians and those health professionals to give them guidance on all of their care, so why would a clinical trial be any different? I think that's something that we really hone in on with our investigators.