ACT: What areas of trial design should stakeholders be focusing on the most to increase diversity within their studies?
Moultrie: Once we account for access, education, and awareness and I think once we’ve got patients in our clinics and we want them to have an equitable experience, I think one of the things we have to look at, for starters, is our inclusion eligibility, and that the ways in which we may unintentionally be excluding patients before they’ve even gotten through that first screening visit. I know the idea that all women of childbearing potential have to take a pregnancy test. Well, for some women of childbearing potential, that should be optional considering lifestyle, gender identity, and sexual orientation when you’re thinking about more disease state-specific things, and this idea of certain patients are more prone to and have a higher risk in certain comorbidities. If you’re looking at kidney disease, for example, when you’re going to set a requirement—inclusion or exclusion requirement around chronic kidney disease—you have to consider that different portions of our population suffer from kidney disease in different ways. There is more prevalence among certain communities, which leads to higher and varying EGFRs, certain kidney disease markers, and traits that don’t exist potentially in other communities or are significantly lower in other communities. Those are things we have to consider when we’re writing inclusion criteria and thinking about when you’re writing these things, who may we be unintentionally excluding and we’re not even meaning to? How can we make sure that everyone we want to have an opportunity to participate here is able to, from the get-go, when reviewing those inclusion/exclusion criteria.
ACT: How important is industry collaboration when it comes to achieving greater diversity in clinical research?
Moultrie: I think it’s a must. I don’t think we can do it if we can’t do it together. On the site side of things, I’ve got patients in the room, and I’m ready, and I’m noticing things are not really panning out the way we plan them, because the best laid plans on paper—you put them in a clinic, you think you know if something’s going to happen, it’s going to happen inside of a clinic, but to be able to share those best practices back to our sponsors and CRO partners, but then also some of our tech vendors to say, “Hey, I know you meant for this to be easily accessible to all patients, but this demographic of my patients is really struggling. Can we consider doing something a little bit different with the technology? This particular assessment—if you thought it was going to take 20 minutes, is actually taking about two hours. How can we refine this process, still getting the necessary information, but to do a bit more so in a way that’s more conducive to the patient experience?” We can only do that if we all are willing to sit at the table and have the conversation around the patient experience and making sure our patients have that that, what we call, white glove service, and making sure that they want to come back and they want to participate, but we all have to be willing to sit at the table, so to speak, to have that conversation around what we can do better, to collaborate.