Expanding Clinical Trial Access Amid DEI Challenges

The ongoing call for research and studies to better reflect a real-world population has never been more important, with experts from across the medical community—from the psoriatic arthritis and prostate cancer spaces to patient navigation experts—sounding the alarm on enhancing diversity in clinical trials and for research to more accurately represent who will receive a treatment.

The current political climate has only served to heighten this awareness, with the FDA’s decision to remove draft guidance on clinical trial diversity from its website sparking controversy almost immediately, as well as diversity, equity, and inclusion (DEI) rollbacks happening at an increasingly fast pace since a January 21 executive order from President Donald Trump.

In this interview, Karen Winkfield, MD, PhD, the Ingram Professor of Cancer Research at Vanderbilt Ingram Cancer Center, professor of medicine at Meharry Medical College, and executive director of the Meharry-Vanderbilt Alliance, speaks to the challenges to getting any patients to participate in clinical trials. She also addresses the importance of inclusive participation, of meeting patients where they are, and of “educating and ensuring that we are doing everything we can to help them from the prevention side.”

This transcript has been edited for clarity; captions were auto-generated.

Transcript

What are the biggest challenges in ensuring more patients participate in clinical trials, and how can we address them?

The clinical trials piece, let's talk about that. That's where being more inclusive is really important. Yes, we need to include voices—patient voices, caregiver voices—in the way that we actually design research, but let me tell you something. We know that, first of all, not enough people are participating in clinical trials. You would think, “Oh my goodness, I have cancer. I'm going to do whatever I can,” but oftentimes the No. 1 reason people don't enter into clinical trials is because there's not one available. The amazing thing is, right here at Vanderbilt, we have tons of clinical trials that are open.

The second most common reason why people don't enter into clinical trials [is] they're not asked. Part of what we try to do at Vanderbilt is create a culture where clinical trials are part of the fabric. It's not something different or extra; it's part of the offerings. That's the beauty of having a National Cancer Institute, an NCI-designated, comprehensive cancer center. Comprehensiveness means there are studies that may help to advance cancer care in the future, but also may have direct benefit for you. That’s part of the thing: We've got to do a better job of creating an environment where every single patient [who] walks through the door who's eligible is actually offered a clinical trial. This is where AI [artificial intelligence] can come in.

It's really hard when you have a lot of patients walking through the door to screen every single patient for eligibility. As much as we'd like to, as clinicians, if we get behind just a little bit, our schedules can be so jammed, it might not be something we think about, honestly. This is where having something where AI can potentially kind of look at people's records in advance and say, “Oh, this person may be eligible for this”—matching people with trials would really be a help.

I know some cancer centers are already starting to kind of look at some of these pathways, etc. A lot of it is a challenge because of natural language processing, but I think [with] the technology now, the technological advances, this is going to be something that'll make things a lot easier.

One of the things I'm very happy about at Vanderbilt, there are faculty members, there are departments and divisions within the comprehensive cancer center that are really doing an amazing job at doing that inclusive participation, asking every single patient. But we also need to make sure that we have access and getting people in the doors. This is where the community engagement piece also helps, with respect to getting the word out about the different types of clinical research that are available to them and making sure that they know that it's safe and all the safeguards that are put in place. All those things are really important to communicate to our communities.

How is your work with the Meharry-Vanderbilt Alliance helping advance these efforts?

The Meharry-Vanderbilt Alliance is a pretty unique partnership between Meharry Medical College, which is one of our historically Black institutions. There are only 4 HBCUs [historically Black colleges and universities] that have a medical school attached to them right now, and Meharry is one of them.

Vanderbilt University Medical Center actually partnered with Meharry 25 years ago to really help to improve training across institutions, but also to do the work of community engagement. We do have 2 clinical research coordinators that do help support enrolling patients on clinical trials, but that's not our primary goal. That whole education component, the conversations we need to have with communities, the need to build trust; institutions need to build trust in communities. That's the work of the Meharry-Vanderbilt Alliance.

From my perspective, it goes beyond whether or not somebody walks into the door of a cancer center or not. It's about meeting people where they are, educating and ensuring that we are doing everything we can to help them from the prevention side, to give them the knowledge that they need, to do the health education, to really help to point people in the right direction.

Say they do come, they have a cancer diagnosis and they have a need. What are the organizations locally that can help support that patient and their family? That's the type of work that the Meharry-Vanderbilt Alliance does. And we do it cross institutionally because again, there are so many amazing things that each institution has to offer. And we can do so much more when we actually work together.