Read the Full Video Transcript

Andrea Miyahira: Hi, everyone. Thank you for joining us today. I'm Andrea Miyahira with the Prostate Cancer Foundation. With me is Dr. Hala Borno, a medical oncologist at UCSF. She will be discussing Trial Library, an amazing, cool tool that she developed to help patients and doctors find and be navigated into clinical trials. Dr. Borno, thanks for joining us.

Hala Borno: Thanks for having me, Andrea. Thank you, Andrea and UroToday, for having me. My name is Dr. Hala Borno. And Trial Library is a technology-enabled research services organization that was spun out of the University of California, San Francisco.

And some of the formative evidence that we generated was really based off of some of the work I did as a Prostate Cancer Foundation Young Investigator. So very much part of the family with a commitment to advancing access to oncology trials. So Trial Library has an innovative software and services model that has changed the way we think about offering patients clinical research.

We function as an advocate, really to advance diversity in clinical trials, to advance representation in whom our trials are serving. And our metrics reflect this story. When you look at the patients that are being referred as a result of our approach, 69% of patients that are referred through a Trial Library platform are non-white, 29% of patients are on Medicaid, 38% have a household income less than $3,500, and 44% of referrals through our platform require transportation support. So a very broadly diverse, from a sociodemographic perspective, pool of patients are being offered clinical research opportunities, and that's critical.

We do this through a provider-first approach. We are working directly with community providers all around the United States. We're in contract with over 1,500 physicians in the United States. This comprises over 300 clinics from coast to coast. And we deploy technology integrated with technology-enabled services to really enable them to offer clinical research studies to their patients.

And the beauty is we are funded by the study sponsors. So we know that patients shouldn't be paying to be able to benefit from clinical research. They have enough on their plate.

Providers, as well as health systems and community-based settings, have a variety of priorities that may not necessarily mean the development or expansion of their research at any given time. They need support. And therefore, we leverage study sponsor funding to deploy this innovative model in a sustainable way across the United States and have accelerated our growth of our engaged community provider network.

What this means is we get an opportunity to support patients that are referred through our network to oncology trials. And we have supported numerous prostate cancer trials. And the patient experience is a delightful one.

We assign patients a non-clinical navigator. This navigator functions as an advocate to evaluate pragmatic needs that patients may have. They really apply what we call a social determinant of health framework. The social determinants of health are the conditions in which we work, live, grow, and play and fundamentally influence our health outcomes. These navigators will evaluate things like food security, travel, lodging, and provide counseling and resources to mitigate these risks so patients can arrive to a trial site and engage in a clinical research opportunity.

They also apply something that's very critical to support a patient, and that is the support of referral management. So when you think about patients that may be referred from one health system to another health system, there are some barriers that may exist. And these barriers include the need for prior authorization. We don't want patients to be navigated to be seen at a new health system without a prior authorization in place, if that's required, as that would place financial risk and burdens on the patients. So our navigators are that necessary touch, that intervention that can mitigate these types of risks for patients so they can truly arrive and discuss a clinical research opportunity.

And what we have shown is this is a delightful experience for patients. This type of intervention at a pre-consent level accelerates clinical trial recruitment overall. It has an impact across all phases of study, and we've demonstrated this through my research that you can have a significant impact on enrollment across all phases of study. We have seen a larger effect on late-phase studies; however, it's also beneficial to early-phase studies.

And here's just an example of what a navigation experience has looked like for a patient with prostate cancer. We had a patient named John, a 79-year-old male with a history of prostate cancer, who was referred to a biomarker-selected oncology clinical trial and required navigation support. The treating health care provider recognized that John would need additional support and referred him to Trial Library Ally Navigation Program.

John was able to make his first appointment due to Trial Library's high touch and technology-enabled navigation service model. Through individualized counseling, the Ally Navigator identified that John had limited social support and unreliable transportation. The Ally Navigator found and scheduled the appointment at the nearby trial site and identified one that could give the patient a timely appointment.

John was sent regular appointment reminders to ensure that he could attend the first visit. Food insecurity and lodging needs were also assessed, but no intervention was required for this patient. We have numerous examples of patients who do need these types of interventions. And private transportation was arranged for this patient.

For John, this was a very positive experience, stating that he had an efficient and timely navigation to the trial site. And it really serves as a testament to the impact of coordinated care and patient-centered support in the clinical trial landscape. It helps.

We have engaged in therapeutic prostate cancer trials as well as observational or registry-based studies. And a very important study that we're involved in, that's continuing to recruit patients, is called the PROMISE Registry. And what we did was community-based, decentralized referrals to this registry study.

We engaged community provider networks to prescreen patients for this study and to refer the patient to undergo a remote consent. Patients were assigned navigators to help them with that process of arriving to the remote platform. The model was well suited for an oncology prostate cancer study, and it really helped engage a broad denominator of patients, a highly diverse denominator of patients, to a genomic study.

And we all know that genomic research is biased, and we do need to engage in these innovative ways to drive more diverse patients to engage in genomic studies. So in a very short period of time, a few months, we were able to generate 264 referrals to this study. And 76% of referred patients indicated interest, and 193 actually enrolled into the study. So this demonstrates the way that you can activate community providers to offer research studies to patients in a very efficient way and making a big impact on health equity.

Another piece of what we do is generate other tools to support busy providers at the point of care. We have a trial search platform. It is live on our website at trial.library.com. It is meant to be provider facing so busy providers at the point of care place the attributes of the patient that they're seeing in front of them and generate a clinically relevant list of studies that are appropriate for their patient.

This list of studies is weighted based on the degree of clinical match. So if the attributes generate a high probability match, the provider sees that result at the top. For a subset of studies where Trial Library is funded to support navigation, there will be a navigation banner there showing that we can provide that high touch support.

But regardless of whether or not navigation is funded, we can provide visibility regarding slot availability. We can help the referring provider connect to the trial site PI. So this really demystifies the clinical trial landscape for busy providers so they can actually know, "Is this study available for my patient today?" before I refer my patient to that trial site and have them deal with the headache and the hassle of navigating another health system.

I will just add that today, the way providers find trials, they may search on certain tools, but they don't know if there are slots available at the trial site. And they really liken this as looking for a flight and not knowing if there are seats on the plane. Looking for a trial and not knowing if your patient can get enrolled can feel like an arduous task that, of course, providers don't want to do it if they can't be assured that their patient can participate.

So we deal with that knowledge gap by providing the necessary support through our technology to help support providers to offer patients trials. Providers need the tools to do this and to make sure that their patients can benefit. So with that, I'd love to hear what questions you have for me, Andrea.

Andrea Miyahira: Thank you so much, Dr. Borno, for sharing this. So what can our listeners do if they are patients or caregivers or providers or scientists?

Hala Borno: It's a great question. So for patients, I encourage you to ask your providers about Trial Library. And ask them, "Are you aware that this is a platform that could help you discover trials that may support me or my family member?" Really, it is a way to demystify the landscape of what opportunities may benefit them.

For study sponsors, I would say consider using Trial Library support to help you engage a more diverse patient population that is representative of the patients that have prostate cancer in the United States. Trial Library partners with study teams to help provide these capabilities in community-based settings to accelerate enrollment overall, but with a big focus on diverse enrollment, which is our key focus area. From a scientist perspective, we work closely with scientists at the level of study design to help you think about eligibility criteria that may be impacting your ability to have an inclusive research study, and then also directly work to help think about ways that we can structure our partnership to help you meet your enrollment goals. So very much designed to be a way that we are functioning as partners and collaborators with the entire research ecosystem, but really serving patients to make sure they have a high touch and supported experience in their journey.

Andrea Miyahira: That is so important, I'm sure very difficult for some patients to access that. So thank you for developing this tool. How long does it take to typically navigate a patient from start to actual trial enrollment?

Hala Borno: So Trial Library targets two weeks from referral to being seen at the trial site. And that's really a standard that we hold ourselves to. It can be faster if the referral is an internal referral. And what I mean by that is, a lot of health systems are multi-site, have several clinics, and so there may be a clinic that doesn't have a study, but its sister clinic does have the study, and that's an internal referral.

Those can happen rapidly because they typically don't require prior authorization. And some of the challenges that can come with health system dynamics. External referrals, however, we hold ourselves to that two-week standard to ensure that patients have the necessary authorizations and don't experience risk by being seen too quickly.

Andrea Miyahira: Thanks. Speaking of insurance, how does the patient insurance play into how the navigation works?

It's a great question. So navigation is funded by the study sponsor. So patients do not incur any costs. We really created Trial Library because we wanted to advance access.

And we recognize that patients shouldn't be paying for the innovation that's required to help them access what they need. We also don't believe that providers or health systems should be paying. We believe that it really is the study sponsor and the study team that needs to commit to deploying the technology and the innovation that's required to help change who gets offered research studies and to make it a better landscape.

Insurance does play a role, however, in clinical research overall. So when you think about participating in a clinical trial, for patients that are considering this, some aspects of a clinical trial protocol may be considered standard of care. So, for example, if you're on a prostate cancer study, it's a treatment study, and they need to monitor your PSA on the study to determine your response to the treatment.

That PSA test may be billed to your insurance because it may be considered a standard of care test. However, aspects of a clinical trial that are considered experimental or investigational are typically paid for by the study sponsor. So if you need a new imaging test as part of that study protocol, and that imaging test is testing out a new type of tracer, that would be paid for by the study team and not be billed to the patient's insurance or impact the patient's out-of-pocket spend.

Andrea Miyahira: Thank you. And aside from prostate cancer, what other cancer types are represented among the trials that are offered?

Hala Borno: So currently, trial search supports 51% of the oncology therapeutic areas, with colorectal, thoracic, prostate, and breast cancer. We're rapidly building out all the clinical indications, so we'll be a total solution across the oncology therapeutic area for trial search in 2025. As it relates to our services, however, that can support any disease area. So we're working on studies in malignant hematology currently and in other solid tumors that aren't currently available at trial search. Our services can support any study for any patient that needs it.

Andrea Miyahira: Thank you. I have to say, it's incredible to see how far this platform has been developed over just a few years. And I'm particularly impressed by the diversity of patients, which we know is important for trials due to the typical underrepresentation of minority groups in trials. So, do you have other plans for expansion that you want to highlight?

Hala Borno: Well, Trial Library is really designed to be a partner to help change the way we think about clinical research to make it so it's not hard for patients to participate. And we're doing this by supporting providers who are the gatekeepers. So 77% of patients that enroll in a trial do so because of a provider recommendation.

We've been partnering with community-based practices today. However, we are excitedly partnering as well with academic medical centers that are partnered with community specialty practices to really help with that integration, to make sure that you are able to engage providers even in a community specialty practice that is now part of an academic medical center. So that's a really nice and exciting direction that we're taking things, and it's a response to the needs that we've identified within the community.

Andrea Miyahira: Well, thank you so much, Dr. Borno, for sharing this with us today and for developing the tool.

Hala Borno: Thank you for your time.