Clinical Trials in the Community Setting Re-Envisioned

In this interview, Lindsay Kehoe, MS, CGC, from Duke University/Clinical Trial Transformation Initiative, details her session on clinical trials in the community setting. She participated in a session titled "Reimagining Clinical Trials in the Community Setting" at the 2023 Clinical Pathways Congress + Cancer Care Business Exchange.

Transcript:

Lindsay Kehoe: Yes, I am Lindsay Kehoe, I am Senior Project Manager at the Clinical Trial Transformation Initiative or CTTI.

How is reach and access to clinical trials becoming incorporated into the community setting?

Lindsay Kehoe: Yeah so we are certainly not there yet, we have always kind of had a lot of clinical research occurring in the big academic medical centers, though it is wonderful that we are thinking about expanding access and expanding reach for clinical trial participants, to try to meet them where they are. But, we know that it’s still an existing problem. We talked about during the panel that there was a systematic literature review that happened a couple of years ago, noting that 8% or less of cancer patients or participants actually participate in clinical trials and 50% would be willing to, and that’s a problem. That’s a problem of access, it’s a problem of as this paper noted, not having the time for providers to talk about clinical trials, not having the compensation to do so, there is sponsors who are re-aligning and always going back to the same sites, large academic medical centers. We find that there’s really misaligned incentives to be able to kind of broaden that reach and to try to support new sites who might be willing to incorporate research. I think we are making progress, we certainly have seen technology enable some support in progress, I think we are realizing in the clinical trial world how important it is to engage with various different stakeholders, to engage with the sites  early on, to understand site readiness, to engage with the regulators, to appreciate trial design, how it could be incorporated better into these various different settings but also how to simplify these trials. Are all the endpoints needed for example for us to capture and collect. I think we are also recognizing the importance of engaging patients early on in that trial design and the last thing I will say, as we continue kind of thinking about reaching access I think we need to consider ways to measure that reach and access, we want to think through where we headed, what are the metrics that we need to get there, and is progress really happening.

What are the challenges of bringing more clinical research into the community setting?

Lindsay Kehoe: Yeah so I think some of the challenges of bringing more trials into new and different locations out into the community, really exists because we have a fragmented research and data infrastructure. We a lot of times, EHR systems don’t talk to each other, so we have a lot of data, incompatibility, we have difficult study startups, that disincentivize new locations to really start studies up. We talked about misalignment earlier and incentives that are just not there for providers who always pick up and do research because it feels like an extra burden on their already heavy clinic load, and we certainly recognize too that there are challenges around if we’re going to use new approaches. We’re going to use new technology, does that increase burden in some ways? Are we expecting sites and providers to always pick up on a new app, a new technology, a new digital platform, and train and learn on it and expect that that’s going to happen seamlessly without a busy workload? We need to consider what that burden might be on the participants too, will every participant understand and have the same level of understanding with using new digital components? We need to understand whether or not they are interested in participating in research, if there’s any sort of confusion or value that they don’t see with the potential for clinical trials and what that can offer, so while I think clinical trials can certainly help improve patient care by providing more treatment optionality, there are definitely some challenges for us that I think we will have to overcome, to go beyond, beyond just kind of the main academical medical centers, but I think is also still persistent within these research sites as well.

And how are technologies and new models changing clinical research?

Lindsay Kehoe: So, technology has definitely been a critical and pivotal component to help increase access and help improve and streamline research processes, there is no doubt about that, but we know that technology has been helping to leverage the EHR, it’s really helping us to maximilate leverage of all available data. It’s real world data that is being captured through digital health technologies to better understand patients and their real-world settings. To collect data, during, outside of the clinical care component, we know that it is helping to identify patients through the EHR, we know that it is helping to streamline processes, I think technology has a lot of capabilities, that have yet to be known to us, as this advent of AI comes along, there are so many new doors that will probably be opened. To help reduce the burden that might be on participants or providers but also, to help streamline and make trials a little bit more efficient, I think the challenges though, and the things that we need to be cautious about are those biases that may happen when we’re incorporating technologies, we need to be considerate of how people adopt new technologies, if there are burdens that are placed on it, and we need to be considerate of evolving technologies and are we maintaining integrity, are we maintaining the safety of the patient, are we, are we keeping true to kind of how a clinical trial should be run? Certainly, I take this from trials that are intended for regulatory review, we need to be certain that that data is still of sufficient quality for regulatory approval.

Do you or your institution have any experience using AI?

Lindsay Kehoe: So at CTTI, we tackle a broad range of different types of projects and topics. We also are comprised of about 80 member organizations and it’s often our member organizations who tell us what projects to take on and AI as you can imagine is a hot topic right now and so it may be an area where CTTI kind of comes forth and does take on something around AI. The benefit of CTTI is that we bring stakeholders to the table and these are not just stakeholders, only industry stakeholders, or only patient stakeholders, we are bringing every sort of different stakeholder together and to the table to address these problems. So really what we need to think through now, is how do we get that multi-stakeholder, what problem can a multi-stakeholder collaboration really tackle in a pre-competitive space. So we are still exploring at CTTI, what is the right topic for us to take on for AI, is it understanding and appreciating all of the applications of AI in the clinical trial space? How it can improve the efficiency and quality of clinical trials? Is it better understanding what that looks like for regulators? There are a lot of different topics that we could potentially take on and we are still sifting through where and how.

Is there anything else you would like to expand on?

Lindsay Kehoe: Yeah, I think I made the point, in the session that there are incentives that I think we still need to work through that are misaligned and one thing that I do wish is that and I made the point during the panel that I hope care can better inform research and research can better inform care. We are at a place right now where it feels like research is very siloed from clinical practice and I hope that we get to a place where research is valued to the point where we feel like it is a part of the care continuum. It is contributing to that greater evidence generation, and we need to get therapies to patients faster, and it really does play a role within our healthcare system a bit more and I think if that value piece is driven then maybe there will be more uptake from providers that are not at these big medical centers and we really are hopeful to uptake more and more clinical trials in the future.