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Why Clinical Trials Keep Missing the Patients They Are Supposed to Help, with Lisa Sonneborn · The Clinical Realist

• 0:01
  SPEAKER_02: So every drug you've ever prescribed and every device you've ever implanted got to you through a clinical trial.
• 0:08
  SPEAKER_02: Somebody enrolled, somebody showed up for a visit, and then another visit.
• 0:12
  SPEAKER_02: And here's the part almost nobody in health tech thinks about.
• 0:15
  SPEAKER_02: Whether that trial ever reaches the patients who actually have the disease depends less on the science than on decisions made in a protocol document, written by people who may have never run a research site.
• 0:27
  SPEAKER_02: So my guest today has spent over 15 years on the receiving end of those documents.
• 0:32
  SPEAKER_02: So Lisa Sonoborn founded the first standalone clinical trial facility in upstate New York, focused on Alzheimer's and Nash, and was named Healthcare Innovator of the Year by the Central New York Business Journal in 2019.
• 0:43
  SPEAKER_02: She built that business, sold it, and then did the thing most founders say they'll never do.
• 0:48
  SPEAKER_02: She started again.
• 0:50
  SPEAKER_02: So in 2024, she co-founded iCorp Research in Syracuse, building diagnostic research infrastructure for cancer, neurodegenerative diseases, metabolic conditions, Alzheimer's, you name it.
• 1:02
  SPEAKER_02: She's also a licensed mental health counselor, which gives her a view of what research participation actually asks of the patient that very few site operators have.
• 1:10
  SPEAKER_02: So Lisa, welcome to the clinical realist.
• 1:13
  SPEAKER_00: Thank you.
• 1:13
  SPEAKER_00: It's good to be here.
• 1:15
  SPEAKER_02: So I wanted to start at the beginning because the beginning is probably a place where most people have never been.
• 1:22
  SPEAKER_02: So you built the first standalone clinical trial site in upstate New York specifically for things like Alzheimer's.
• 1:29
  SPEAKER_00: Yeah.
• 1:29
  SPEAKER_02: What did the market look like when you started?
• 1:31
  SPEAKER_02: And what was the thing you assumed would be easy that turned out to not be easy at all?
• 1:36
  SPEAKER_00: All of it.
• 1:37
  SPEAKER_00: Let's just say all of it.
• 1:38
  SPEAKER_00: But um so starting the first ever clinic is just like I think anyone who's trying something new felt like a really big leap into kind of an abyss of questions um and mysteries.
• 1:51
  SPEAKER_00: And it proved to be a lot of that as I worked through kind of piece at a time.
• 1:55
  SPEAKER_00: But um Syracuse was both kind of a a lucky find and also um turned out to be the right thing in the end.
• 2:02
  SPEAKER_00: So I was born and raised in Syracuse, my hometown.
• 2:05
  SPEAKER_00: Um and coming back was one of those things that happened just because kind of life pushed me in that direction.
• 2:11
  SPEAKER_00: Um, wanted to have a family near where you know parents and in-laws were.
• 2:16
  SPEAKER_00: But when I looked around at the thing I had done um in Florida for a number of years, so I'd worked at a private research site in Florida, came back to Syracuse and realized there really wasn't private research.
• 2:28
  SPEAKER_00: It was only in you know large institutions which are scattered in certain areas around central and upstate New York.
• 2:35
  SPEAKER_00: Um so what did that mean to me?
• 2:38
  SPEAKER_00: The first thing is it meant, oh man, am I like setting up shop next to the big guys and gonna actually try to do this?
• 2:44
  SPEAKER_00: But the other thing it meant to me that I know is true from experience or the experience I had that uh thus far was what you can provide in a small community-based private research clinic is very different than what can often be provided at really large institutions, where research still is a really valuable add-on, but becomes one of many things in the portfolio of services.
• 3:10
  SPEAKER_00: So when you're a dedicated research site, all you do all day, every day is figure out the protocols that you need to execute and how to get those in front of and an opportunity to the right participants.
• 3:24
  SPEAKER_00: Um, so it it's really kind of a niche type of approach of research to be able to spend all day creating operations and solving puzzles around bringing studies to those who need them.
• 3:37
  SPEAKER_00: Um Syracuse was really fun because that didn't exist, so I got to be the first to pioneer that, but also a challenge because can't tell you how many people looked at me and said, wait, you can't do that.
• 3:48
  SPEAKER_00: No, that's not a thing.
• 3:50
  SPEAKER_00: No one does that.
• 3:51
  SPEAKER_00: Um and the answer was, well, it's about to be a thing and we're gonna do it.
• 3:55
  SPEAKER_00: And we did.
• 3:55
  SPEAKER_00: So that was kind of how the the project started.
• 3:58
  SPEAKER_00: Um, being trained historically, and our and my specialty as a researcher being in neurodegenerative diseases like Alzheimer's adds a layer of complexity when you think about setting up a standalone research site.
• 4:13
  SPEAKER_00: Unlike studies that look to enroll healthy volunteers, where I can probably throw, you know, a flyer out on Facebook and find anyone 18 plus who wants to volunteer for a healthy study, you're looking at engaging people who often aren't necessarily out seeking this information, maybe don't have access to the internet or um different social media platforms as much as other age groups or populations, and sometimes even as a result of their disease, would require additional individuals to help them get access to studies, legally authorized representatives, healthcare proxies.
• 4:49
  SPEAKER_00: So there's a lot of complexities there that we had to figure out.
• 4:52
  SPEAKER_00: Um, and that's really where we started the journey of creating kind of a new model of research that didn't wait for patients to find us, but figured out how to transform the studies we were working with so that we could bring them to the patient.
• 5:06
  SPEAKER_00: So that it started slowly, we realized the problem, and it did take us a long time, but we've um over time, you know, piece at a time, been able to mold um the processes in the infrastructure of what we do to change how research works and and actually set a model that is now being looked at kind of nationwide.
• 5:27
  SPEAKER_02: I love that.
• 5:28
  SPEAKER_02: When we think about kind of that gap, so there's a gap between how trials are designed and what sites can actually deliver.
• 5:36
  SPEAKER_02: So a lot of trial protocols are designed by teams, I'm gonna say this tongue in cheek, who've never run a site.
• 5:42
  SPEAKER_02: And so when you look at the eligibility criteria list, what's that one line item that immediately tells you the trial wasn't designed with real patience in mind?
• 5:51
  SPEAKER_02: Now, I'll put mine forth.
• 5:53
  SPEAKER_02: Like anytime it's like BMI over whatever, I'm like, oh my goodness, do you know who lives here?
• 5:57
  SPEAKER_02: Like this is this is gonna be impossible.
• 6:00
  SPEAKER_02: But what is it that you see, Lisa?
• 6:01
  SPEAKER_00: Well, it's funny you say that because you said one line item, and I'm like, what are the 20 line items that tell me?
• 6:06
  SPEAKER_00: Um, but I think so.
• 6:08
  SPEAKER_00: I I actually kind of feel for all parties here, right?
• 6:12
  SPEAKER_00: We've got sponsors or pharmaceutical companies or even small biotechs who are staking a lot of what they have on this study.
• 6:19
  SPEAKER_00: So there is a lot on the line when someone's getting ready to run a clinical trial.
• 6:23
  SPEAKER_00: I mean, the funding alone to run even a phase two is pretty significant.
• 6:28
  SPEAKER_00: Yeah.
• 6:28
  SPEAKER_00: And if you mess it up, you're not getting your money back.
• 6:32
  SPEAKER_00: Um, so the design is something that needs to satisfy a lot of different parties.
• 6:37
  SPEAKER_00: It needs to satisfy the FDA in terms of what those endpoints are and how it's how patients are being monitored for safety.
• 6:45
  SPEAKER_00: It also needs to kind of satisfy the sponsor and what questions they're trying to ask and what answers they need to be able to move on to the next phase.
• 6:54
  SPEAKER_00: And then simultaneously, they're thinking, okay, but clinically, the sites and investigators and physicians we're working with probably need to be able to find some of these patients.
• 7:04
  SPEAKER_00: So they're getting pulled in all of these different directions.
• 7:07
  SPEAKER_00: Not to mention you got biostats always saying, like, you're gonna have to change 500 things and get a million more people in order to get what we need from a power perspective here.
• 7:15
  SPEAKER_00: So all of these different stakeholders have a say.
• 7:18
  SPEAKER_00: And when you bring when you bring together that many opinions, all of which are valid and really important for you know a study that's um scientifically rigorous and valid, you're gonna continue to add layers of complexity and requirement.
• 7:33
  SPEAKER_00: Until what we often end up with, even in some of our um more progressed studies, are hundreds of pages of protocol document telling us what we need to do, when we need to do it, um, and what patients are appropriate.
• 7:46
  SPEAKER_00: So when we think about um when we think about studies and kind of common barriers, let's let's talk about Alzheimer's, because I think that's the one where we've made a lot of progress, both educating um the scientific community and and specifically the clients and pharmaceutical companies we work with.
• 8:04
  SPEAKER_00: If studies are designed that require patients to independently find the information, engage in it, but then also have um consistent, very specific support from people in their life, literally defined down to how many hours they can see certain family members a week or our loved ones to be able to participate in a study.
• 8:34
  SPEAKER_00: These types of things become really challenging for a research site.
• 8:38
  SPEAKER_00: So a lot of the work we do, especially with moderate to severe Alzheimer's disease, expects participants to be at home with a caregiver who's with them many times a day, who can take great notes from a medical and medication standpoint, who knows how to observe and record very specific type of neuropsychiatric behaviors.
• 8:58
  SPEAKER_00: This isn't a reality for most people with moderate to severe Alzheimer's disease.
• 9:03
  SPEAKER_00: I mean, so many people need assistance from private caregivers, or they're in residential communities like assisted living or memory care.
• 9:11
  SPEAKER_00: Um and what we really recognized is that the way protocols were being designed, it was excluding, I mean, a very significant portion of the patient population who actually needs access to these medications and who ultimately would be on the receiving end of the prescription if it becomes commercially available.
• 9:30
  SPEAKER_00: Um so it took us a few years, kind of tweak at a time, of approaching sponsors and saying, what if you thought about this differently?
• 9:37
  SPEAKER_00: What if we defined the role of an informant or an observer, someone who's helping report on neuroscience?
• 9:45
  SPEAKER_02: Sounds like a spy movie.
• 9:46
  SPEAKER_02: I love informant.
• 9:48
  SPEAKER_00: So in clinical trials, if your endpoint is someone's behavior, you have to have someone who can actually report on the behavior.
• 9:53
  SPEAKER_00: Someone with cognitive impairment is is not the best person to report on their own behavior.
• 9:58
  SPEAKER_00: So you need someone objective, right?
• 10:00
  SPEAKER_00: Um sometimes it can be a family member, but oftentimes that isn't the best choice.
• 10:04
  SPEAKER_00: It's just going to create extra burden for someone who's already oftentimes kind of at the edge of what they can handle.
• 10:10
  SPEAKER_00: Um so we created ways to take that burden off of family and be able to place people there to do observations.
• 10:17
  SPEAKER_00: Um, we worked with protocols that said patients have to be at home, and we said, that's unrealistic and there's no reason.
• 10:22
  SPEAKER_00: If they're in an assisted living, we can run the protocol.
• 10:25
  SPEAKER_00: We will take everything to them.
• 10:27
  SPEAKER_00: Our physicians, our lab, our neuropsychiatric testing teams.
• 10:32
  SPEAKER_00: We basically created the ability to include millions of Americans who otherwise would have been excluded by a few simple lines in a protocol.
• 10:41
  SPEAKER_00: Um, but it didn't come easy.
• 10:42
  SPEAKER_00: I can tell you we've had studies that we executed for about a year without making those changes.
• 10:48
  SPEAKER_00: And it was when the sponsors and the studies realized, oh man, we really are struggling to get patients into this program that they came back to the table and said, okay, let's talk.
• 11:01
  SPEAKER_00: So the struggle is very real um and that they they want to stay as strict as they can because um it takes a lot of time, energy, and honestly resources and money to make even the smallest changes to a protocol.
• 11:14
  SPEAKER_00: But I think we are getting to a point now where people are realizing that in order to be successful in these studies and and get it in front of the patients who who need it, um, and to get data that's reflective of the actual population they want to serve and treat, you have to start thinking outside the box.
• 11:32
  SPEAKER_00: And that's really where we feel we've been pretty successful so far.
• 11:36
  SPEAKER_02: Now, I know you guys have a great track record, but when we think about the eligibility, that's the front door.
• 11:43
  SPEAKER_02: Then the patient has to kind of keep showing up.
• 11:45
  SPEAKER_02: And I do appreciate that bringing the studies to them makes a huge difference.
• 11:49
  SPEAKER_02: But we think about these remote populations, complex diagnoses, multiple visits, sometimes lots and lots of visits.
• 11:56
  SPEAKER_02: What's the actual dropout math for a trial at a small site versus what the protocol assumed?
• 12:01
  SPEAKER_00: Oh my goodness.
• 12:01
  SPEAKER_00: Well, it really depends on the indication you're studying.
• 12:04
  SPEAKER_00: So we think of this in clinical trials as retention rates.
• 12:08
  SPEAKER_00: Um, my ability to retain patients in a study for, you know, uh obesity where I'm looking at a GLP1 and it's in a relatively healthy patient population, often they're really motivated.
• 12:22
  SPEAKER_00: In many cases, they have the ability to come to the clinic to perform visits.
• 12:26
  SPEAKER_00: But we also do studies like substance use disorders or studies with people who are frail or really ill and leaving their home, whether it be because economically that's difficult or physically and medically that's difficult, we need to create something to support those patients.
• 12:42
  SPEAKER_00: Um, right off the bat, based on kind of what we know about the patient population, across all studies, it's silly now if a sponsor is gonna tell me they won't help with transportation.
• 12:53
  SPEAKER_00: That's like a number one given nowadays.
• 12:55
  SPEAKER_00: We need to be providing people transportation to us if they don't have transportation, can't afford it, or even if they're uncomfortable with it.
• 13:02
  SPEAKER_00: I mean, we're in Syracuse.
• 13:03
  SPEAKER_00: There's days where a lot of people are like, I don't want to drive.
• 13:06
  SPEAKER_00: Guess what?
• 13:06
  SPEAKER_00: We're gonna get you a ride, we'll make sure it's driven.
• 13:08
  SPEAKER_01: I feel the same way.
• 13:09
  SPEAKER_00: Right.
• 13:09
  SPEAKER_00: And we'll make sure it has four-wheel drive for you.
• 13:12
  SPEAKER_00: Not to mention, if people are, you know, trying to bring themselves and a loved one, they may feel more comfortable having a car get them.
• 13:19
  SPEAKER_00: Um, so that was kind of like the first, I'm gonna call it lowest benchmark of trying to increase um access for people in rural locations or who might have transportation barriers.
• 13:31
  SPEAKER_00: But then when you think about retention for people uh, you know, who might be even further out, one of the things that we try to do with sponsors early on is really negotiate the procedures of the protocol to ask questions and to challenge them to say, does this thing you're asking for from a data perspective need to be in person, face to face, or is there an element of this that can be done remotely or that can be done in their in their home?
• 13:57
  SPEAKER_00: Because if so, let's have the conversation early.
• 14:00
  SPEAKER_00: It has to be approved in writing in the protocol for us to be allowed to do it.
• 14:04
  SPEAKER_00: But if it's not going to impact the integrity of your data to allow remote telehealth or you know, in-home visits, then let's create the flexibility for the patients who need it so that we can try to do those things.
• 14:16
  SPEAKER_00: Um, and and the first kind of big wave of seeing some some comfort with that in the pharmaceutical world was during COVID, right?
• 14:24
  SPEAKER_00: If anyone wanted to run a study during COVID, you had to start getting comfortable doing some things remotely.
• 14:30
  SPEAKER_00: Um and there was a little bit of a pullback after some of uh the encouragement for remote access um wasn't necessarily required even by by states anymore, but it gave us just enough of an opening with the door to kind of say, like, well, we're not closing that opportunity now.
• 14:45
  SPEAKER_00: We want to keep that open because it is something that will increase access and inclusion in studies.
• 14:52
  SPEAKER_00: Um, and it's something, honestly, that will make a difference in in retention rates long term.
• 14:57
  SPEAKER_00: I think studies have become better about predicting uh what retention rates are, but part of that is they're significantly better about having conversations proactively with sites to ask us what our opinion is.
• 15:10
  SPEAKER_00: What are gonna be the barriers to you to retain these patients, and what do you need from us as the sponsor of the pharmaceutical company, whether it be resources or you know adjustments or clarification on the protocol to be able to make this easier on the patients in your community that you're gonna be working with.
• 15:27
  SPEAKER_00: And and Syracuse is kind of a unique area because we have, you know, the Syracuse Hub, but we're surrounded by counties that are pretty rural.
• 15:34
  SPEAKER_00: Um, so we talk to them frequently about when we're doing direct community engagement, we're on a bus line.
• 15:40
  SPEAKER_00: A lot of those people can use that.
• 15:41
  SPEAKER_00: We can provide transportation.
• 15:43
  SPEAKER_00: Um, but if we want to engage people 25, 30 minutes outside of Syracuse, we're gonna start need to thinking about what other things we can engage here to continue that that retention effort.
• 15:55
  SPEAKER_00: So it's a conversation that needs to happen long before you start consenting and enrolling patients.
• 16:00
  SPEAKER_02: Now, I know you're a Syracuse human from the beginning, um, and so it made sense to kind of start that back here where there was a need.
• 16:08
  SPEAKER_02: But you could have started your businesses in Boston or the research triangle or anywhere.
• 16:14
  SPEAKER_02: And I'm sure that's where most CROs are gonna build, because I know lots of CROs out in Boston.
• 16:19
  SPEAKER_02: Um, but what's the case for a diagnostic research site in a mid-sized upstate New York City?
• 16:25
  SPEAKER_02: You know, this is not a big humongous market, it's a mid-sized market.
• 16:30
  SPEAKER_02: So what does it mean from a business perspective?
• 16:32
  SPEAKER_02: And why shouldn't we're clinical trial organizations kind of consider mid-market?
• 16:38
  SPEAKER_00: So there's a few things I think that played into this, and a lot of them are are personal, not like family, but personal from a business perspective.
• 16:46
  SPEAKER_00: Um I think what has made us really successful is our ability to find and collaborate with other professionals in the Syracuse area.
• 16:59
  SPEAKER_00: Um, when I was first doing Alzheimer's research, it was in Florida.
• 17:03
  SPEAKER_00: And they tell everybody if you're gonna be in Alzheimer's research in Florida, it's kind of like working at Starbucks, because on every corner there's an Alzheimer's research site.
• 17:10
  SPEAKER_00: So if you don't like the opportunities at this one, go a half a mile down the road and you can find out what research opportunities they have down there.
• 17:18
  SPEAKER_00: Um so there are markets right now that are kind of known and identified as saturated with certain therapeutic area um clinical research opportunities.
• 17:26
  SPEAKER_00: Upstate was interesting to me because um remember when I had a uh familiarity with it, um, I knew kind of some of the moving pieces and and there is something about um upstate New York, or Central New York, I should say, that feels it it has a family feel.
• 17:47
  SPEAKER_00: People are kind of loyal to each other here.
• 17:48
  SPEAKER_00: When you're an upstate New Yorker, you're an upstate New Yorker.
• 17:51
  SPEAKER_00: We like our bagels a certain way.
• 17:53
  SPEAKER_00: Um, like we we have our things.
• 17:55
  SPEAKER_00: We like to go apple picking in the fall.
• 17:57
  SPEAKER_00: Um, but the other thing is I think people were open to looking for new opportunities, not from a not because they everyone was looking for kind of financial um uh clinical research is you know, is not the place when you're starting a site that you're gonna be able to pay everyone you work with a huge amount of money, but they were looking to bring innovation into a place that mattered to them because it wasn't there and there's an uh and people identified that it was lacking.
• 18:23
  SPEAKER_00: So talking to doctors really about what we wanted to do in community-based clinics, people who were serving underrepresented um patient populations, they saw a need in their patients that wasn't being fulfilled, and they saw what these opportunities could bring to them.
• 18:39
  SPEAKER_00: So there was just such a gap.
• 18:41
  SPEAKER_00: And I think this isn't this isn't unique necessarily to Syracuse, but in a lot of mid or smaller size cities, there are people who are suffering because they have illnesses where there aren't great treatment options, or maybe they don't um have the ability to afford what those treatment options are, um, or even geographically, they can't get access to it.
• 19:03
  SPEAKER_00: And the providers who care for them struggle with that.
• 19:06
  SPEAKER_00: So we were able to connect with those providers um uh at every level, you know, nurse practitioners, um, even counselors and some of the mental health work we do that said, yeah, we have patients who need this stuff every day and and truly don't have anywhere to turn unless they want to drive three and a half hours.
• 19:22
  SPEAKER_00: So there was just such a need, I think, kind of in the hearts of the central New Yorkers to be able to bring something to those that they were caring for.
• 19:30
  SPEAKER_00: Um, and listening to that need, I mean, we we knew where we were starting because my specialty was Alzheimer's, but that's what really drove the areas that we grew into.
• 19:39
  SPEAKER_00: Um substance use disorders, mental health conditions like uh treatment resistant and major depressant.
• 19:45
  SPEAKER_00: Um, these were the things that we heard from our providers in our community clinics were struggles.
• 19:51
  SPEAKER_00: So those are the areas that made sense for us to pursue and bring research opportunities.
• 19:55
  SPEAKER_00: So it's always been about for me, um, what is the heart of the problem in the in the place that we live?
• 20:02
  SPEAKER_00: What are the needs that we're hearing from the patients and providers that we see?
• 20:06
  SPEAKER_00: And if we if we can kind of fill that gap and respond to those needs, it's a no-brainer.
• 20:11
  SPEAKER_00: At that point, it's it's about relationship, it's not about business anymore.
• 20:16
  SPEAKER_02: So let's talk about saying no.
• 20:18
  SPEAKER_02: I think a lot of folks, especially when they're starting out, will say, Oh, of course we could do all these studies, of course, that which we'll try to apply to every single study that you know has legs.
• 20:29
  SPEAKER_02: You've told me before in our previous conversations that one of the best things that you've done is to be extremely selective about the studies that you've chosen to do at your organization.
• 20:41
  SPEAKER_02: Tell me a little bit about saying no and the selection process as the site, not as the sponsor, but as the site on how you decide what the best studies are gonna be for you to be successful.
• 20:56
  SPEAKER_00: I think saying no at a especially when you're a small business, is both one of the most important things that you can do and the riskiest thing that you can do.
• 21:06
  SPEAKER_00: So when you first start, most businesses are gonna say yes to almost anything that could potentially be revenue generating.
• 21:14
  SPEAKER_00: Um, because from a growth perspective, you you need something to both open the doors and then keep the doors open.
• 21:22
  SPEAKER_00: But I think it's really easy to get distracted in noise that doesn't align with your true expertise, and all that ends up doing in the long term is distracting you from what is the ability to create uh quality, in our case, quality data, or it would be a quality product in another business.
• 21:44
  SPEAKER_00: And it limits the ability to grow in the areas that are really meaningful to you and that that drive kind of the heart and mission of your business.
• 21:52
  SPEAKER_00: So for us, when we started, um, I think people looked at us kind of crazy, you know, sideways and crazy because of the types of studies that we decide.
• 22:00
  SPEAKER_00: To engage on in the beginning.
• 22:02
  SPEAKER_00: They were typically some of the hardest studies out there.
• 22:05
  SPEAKER_00: They were certainly not the highest revenue generating studies, but we knew that what we could do was provide kind of a unique access and unique approach to those studies.
• 22:18
  SPEAKER_00: And in the long run, what that did for us is it it built a relationship between us and those patients, and it built a relationship between us and that client or that sponsor who is running the study.
• 22:28
  SPEAKER_00: Those things will never be forgotten on either side.
• 22:33
  SPEAKER_00: So for me, it's about the long-term impact of a decision to say yes or no.
• 22:38
  SPEAKER_00: And sometimes you're going to say no to things that if they're too far outside what your area of expertise are, and you can't perform it well, and you can't perform it well, ultimately what that will do is that will end up creating kind of a moderate success rate for you.
• 23:02
  SPEAKER_00: You won't be the best site to execute it.
• 23:04
  SPEAKER_00: You may have more trouble enrolling it.
• 23:07
  SPEAKER_00: And the client that you did it for is not likely to come back to you again.
• 23:11
  SPEAKER_00: So we picked only those things that we knew we were going to knock out of the park, which meant saying no to a lot of opportunities.
• 23:17
  SPEAKER_00: And we um by doing that have gotten a lot of repeat business from those groups that we did say yes to, even if they were much smaller projects.
• 23:24
  SPEAKER_00: Now we know those groups, we have personal relationships with them, and they will likely bring us future programs.
• 23:30
  SPEAKER_00: So saying no is I think really important both from the concept of creating credibility, creating quality in what you do, and being able to scale in an area you're an expert in.
• 23:50
  SPEAKER_00: You shouldn't be saying yes to something you're not an expert in, anyways.
• 23:54
  SPEAKER_00: Um, but we we see it happen all the time.
• 23:56
  SPEAKER_00: And then if a site or research pro uh research entity fails at conducting that, you don't really get another shot.
• 24:03
  SPEAKER_00: So you really got to kind of stick to stick to the areas you know you're gonna crush, basically.
• 24:09
  SPEAKER_02: I like that.
• 24:10
  SPEAKER_02: So when we think about moving forward, it's 2026, AI is everywhere, and AI and clinical trials has been a really interesting topic because it's been utilized for everything from drug discovery to enrollment to operations.
• 24:27
  SPEAKER_02: Um, as a small organization, have you dug in deeply from an AI perspective, or is it something that you're looking into today?
• 24:38
  SPEAKER_00: AI feels like it's everywhere right now, um, especially in the clinical trial site space.
• 24:44
  SPEAKER_00: So, you know, literally for facilities like ours, um, where we are seeing the patients, when I go to conferences now, three-quarters of the expo exhibit hall is all AI platforms and service providers.
• 25:02
  SPEAKER_00: The problem that I think we have kind of across the board is that AI is so new that there is discomfort at the site side.
• 25:12
  SPEAKER_00: I mean, we're dealing with very sensitive data, we're dealing with patient data, we're dealing with dealing with protocols which are highly confidential, and the data surrounding the investigational medications.
• 25:23
  SPEAKER_00: Um, and there aren't clear regulation or regulations or guidelines for business owners to help make decisions on what would meet all of the compliance requirements for different AI platforms.
• 25:36
  SPEAKER_00: I think that's still really missing.
• 25:38
  SPEAKER_00: Um, we have sponsors or pharmaceutical companies who literally will ban us in our contracts with them from utilizing AI in any way on the clinical trials because there aren't really these great sets of guidelines that they can say, show me this one certification or one stamp of approval that says it's going to be able to keep um this type of information confidential in this way, right?
• 26:05
  SPEAKER_00: Um, so I think that's one of the issues that we're seeing is there's still mistrust on the sponsor side and what they say goes when it comes to what types of platforms you can use to some degree.
• 26:15
  SPEAKER_00: Um, and then there's extra, extra, extra precaution.
• 26:19
  SPEAKER_00: What we're doing at the research side is so regulated, right?
• 26:22
  SPEAKER_00: We fall under Health and Human Services with HIPAA, we fall under the FDA regulations and good clinical practice.
• 26:31
  SPEAKER_00: Unless you have ways of validating that whatever platforms you're onboarding meet all of the requirements of all of those different regulatory authorities and boards, you're putting yourself and potentially your patients at risk.
• 26:43
  SPEAKER_00: So I think sites have been very shy and hesitant to onboard AI.
• 26:48
  SPEAKER_00: Um, I do think there's other parts of the pipeline though where AI is starting to play some really significant roles.
• 26:56
  SPEAKER_00: Uh early drug development, we're seeing some interesting things there with kind of uh the drug ideation process.
• 27:03
  SPEAKER_00: Um, we're also seeing, even in the data processing, right, when we have anonymized data that needs to be looked at mid-trial throughout the clinical trials, or even um looking at blinded data to quality control it, these have historically been very manual, human-centered, labor-intensive processes where there are opportunities because there's already safeguards in place with some of the um, you know, coding of patient data, where you can roll that right in.
• 27:31
  SPEAKER_00: So we are seeing those things kind of jumping into play a little bit faster.
• 27:36
  SPEAKER_00: But I think when it comes to the the patient-facing aspects of what actually happens in a clinical trial, I have seen very limited um adoption uh of different platforms or methods so far.
• 27:51
  SPEAKER_00: Everyone's still kind of waiting back to see how some of it shuffles out, and there it hasn't been a fast-moving process.
• 27:57
  SPEAKER_02: So I know that one of the things I love most about the team that you've put together and your organization is really bringing clinical trials to where the patients are, being super communicative with the sponsors and finding ways to bring people into trials that normally wouldn't have that access.
• 28:15
  SPEAKER_02: And I think that the community outreach and connection is so vitally important.
• 28:23
  SPEAKER_02: When you think about bringing folks into trials that normally wouldn't have access to them, where have you found maybe the biggest successes or the biggest barriers?
• 28:37
  SPEAKER_00: So our I think our biggest success and the one that we're kind of known for so far is um being able to serve and engage individuals with moderate to severe neurodegenerative diseases who are no longer living at home.
• 28:56
  SPEAKER_00: Um these folks, as we talked about earlier, have historically been excluded from participation in clinical trials simply because of um the way that protocols were designed, but then also the barriers of trying to conduct regulated clinical trials inside of assisted living or memory care facilities, where those places have their own set of regulations they have to follow.
• 29:21
  SPEAKER_00: So pairing those things together has historically been a failure for most people who've ever tried it.
• 29:28
  SPEAKER_00: Um I think what we were lucky enough to do in our partnership with Loreto was sitting down kind of all the way from the top of Loreto and thinking through it a piece at a time and identifying how to create collaborations, talking through every barrier and piece of red tape on both sides to figure out how we create solutions through each piece of that.
• 29:53
  SPEAKER_00: And and in all honesty, it the conversation started back in 2017 and we're doing it now, but that took a long time to make it happen.
• 30:03
  SPEAKER_00: Where I think most research sites who ever attempted it said, this is certainly not worth it.
• 30:08
  SPEAKER_00: No one's paying us to figure this out, so we're gonna let that go.
• 30:12
  SPEAKER_00: Um, so I think part of it was just the concept there of integrating two very different models.
• 30:20
  SPEAKER_00: Um, but we've now been successful in doing that and have conducted multiple clinical research studies inside of assisted living and memory care facilities, um where, you know, often we're told by sponsors there are no other sites in the US who are effectively able to do this.
• 30:38
  SPEAKER_00: You guys are the only ones.
• 30:39
  SPEAKER_00: And then the next question that always follows is can you write up how you did it so someone else can do it?
• 30:44
  SPEAKER_00: I'm like, that that's a book.
• 30:46
  SPEAKER_02: That is a book.
• 30:46
  SPEAKER_00: That's absolutely that would be a book.
• 30:48
  SPEAKER_00: I don't have that written yet, but I I will work on sharing the information with anyone we can.
• 30:53
  SPEAKER_02: I love it.
• 30:54
  SPEAKER_02: I love it.
• 30:54
  SPEAKER_02: Well, at the end of every podcast, I asked every guest two questions.
• 31:00
  SPEAKER_02: I'm gonna ask you the same questions.
• 31:01
  SPEAKER_02: Okay.
• 31:02
  SPEAKER_02: Um, uh, what's your favorite mac and cheese?
• 31:04
  SPEAKER_02: I'm no, no, no, that's not the book.
• 31:07
  SPEAKER_00: I was like, darn, I can't eat gluten or dairy.
• 31:09
  SPEAKER_00: I know.
• 31:10
  SPEAKER_02: That was that was totally loaded right there.
• 31:13
  SPEAKER_02: What's the clinical reality that most people in health tech get completely wrong?
• 31:23
  SPEAKER_00: Oh my gosh.
• 31:25
  SPEAKER_00: Um, okay.
• 31:27
  SPEAKER_00: So I think, and I'm just this is like a broad swipe.
• 31:30
  SPEAKER_00: We often have people um bring us what they see as the solution to a problem that they have created without any input from the purpose, the person that it would either serve or is intended for.
• 31:46
  SPEAKER_02: All right, drop that mic.
• 31:47
  SPEAKER_00: We could talk about that for billion hours, done.
• 31:50
  SPEAKER_00: I mean, that's like protocols being one of them, but um even in like medical device, there are so many people with solid, phenomenal ideas to solve a problem.
• 32:02
  SPEAKER_00: But the issue with the idea is whether it can be actually commercialized or marketed, and in the geography you want to sell it in, does it fit into what is the standard of care there?
• 32:12
  SPEAKER_00: The US is like notorious for having, I mean, like super fragmented and segmented uh healthcare system.
• 32:20
  SPEAKER_02: What are you talking about, Lisa?
• 32:22
  SPEAKER_00: Oh, I'm sorry, it's all it's all perfect and everything's lovely, and I can it just flows perfectly.
• 32:26
  SPEAKER_02: That's the quote I'm gonna put everywhere now.
• 32:27
  SPEAKER_00: Everything's perfect.
• 32:28
  SPEAKER_00: It's all great, everything's lovely.
• 32:30
  SPEAKER_00: But but when they're doing that design, even if they've solved the problem, it's not gonna solve the problem if it doesn't fit into the system.
• 32:37
  SPEAKER_00: Yes.
• 32:37
  SPEAKER_00: And I think that's constantly missed.
• 32:40
  SPEAKER_00: There's so much that has to go into the research and development of a therapeutic or a device, and it's not just whether or not it solves half of it, it has to solve the whole puzzle.
• 32:49
  SPEAKER_00: And the puzzle is both does it solve the the medical problem we have and does it fit into the system that we have?
• 32:55
  SPEAKER_00: And if the answer to one of those is no, we probably need to go back to the drawing board and reconsider.
• 33:02
  SPEAKER_02: It's a good one.
• 33:04
  SPEAKER_02: The second question is when's the last time you changed your mind about something in this industry?
• 33:09
  SPEAKER_00: Oh I don't know, 30 minutes ago.
• 33:14
  SPEAKER_00: On the way to work when I was calling my business partner, just like rambling ideas.
• 33:18
  SPEAKER_00: Um we are trying to solve really weird problems every single day in clinical trials.
• 33:25
  SPEAKER_00: So some of that requires creativity that hasn't there is no answer.
• 33:31
  SPEAKER_00: Unlike standard of care medicine that says, you know, if this lab value, you know, if if you if the urine pregnancy test comes back positive, here's your next step.
• 33:42
  SPEAKER_00: Go confirm it one more time.
• 33:44
  SPEAKER_00: We run things in clinical trials where something happens and it's new and we've never seen it before.
• 33:51
  SPEAKER_00: Sometimes never seen it before in a person, right?
• 33:55
  SPEAKER_00: Especially when you're running early stage studies.
• 33:57
  SPEAKER_00: So sometimes we have to solve both kind of medical mystery questions, but also process questions.
• 34:03
  SPEAKER_00: There's no guidance on how to handle this.
• 34:06
  SPEAKER_00: So we are working with multiple team members to say, what's the best method of exploring and investigating this?
• 34:14
  SPEAKER_00: What's the best method of solving a problem?
• 34:17
  SPEAKER_00: And who are all the stakeholders?
• 34:19
  SPEAKER_00: Is the ethics and IRB need to be involved in this conversation?
• 34:23
  SPEAKER_00: Do healthcare proxies and patients need to be involved in this conversation?
• 34:26
  SPEAKER_00: Do all of the investigators nationally and locally need to be involved?
• 34:30
  SPEAKER_00: And sometimes it means bringing together full teams of people to solve one question that hasn't ever come up before.
• 34:36
  SPEAKER_00: And that happens on a daily basis.
• 34:38
  SPEAKER_00: So I'm constantly changing my mind as I'm getting information from all the stakeholders.
• 34:43
  SPEAKER_00: And I would say that happens 10 times a day at minimum.
• 34:47
  SPEAKER_02: At minimum.
• 34:47
  SPEAKER_02: Well, Lisa, thank you so so much.
• 34:49
  SPEAKER_02: I think this is exactly the conversation that protocol writers really need to hear.
• 34:54
  SPEAKER_02: So what a trial actually costs the site and the patient, what it takes to build the infrastructure that reaches people.
• 35:00
  SPEAKER_02: For sure.
• 35:00
  SPEAKER_02: Big centers maybe never will.
• 35:02
  SPEAKER_02: Um, but thank you so much for your time.
• 35:04
  SPEAKER_02: Before we go, tell people where they can find you and where to find iCore research.
• 35:08
  SPEAKER_00: Yeah, so if people are interested in our clinical trials or the types of studies we do, um iCor ICHORClinic.com has a list of all the different therapeutic areas that we specialize in.
• 35:20
  SPEAKER_00: Folks can always get involved with a process called pre-screening.
• 35:25
  SPEAKER_00: That's a really fun way of basically sharing some information about yourself.
• 35:28
  SPEAKER_00: It gets into our database, and then as studies become active, we can match you to those study opportunities.
• 35:34
  SPEAKER_00: Um, it's always important to know any research study is always voluntary, so no one ever is, you know, committed for life just by expressing interest.
• 35:43
  SPEAKER_00: The goal is that we want to bring opportunities to people so that they know about them and they can decide themselves if it's something they want to do.
• 35:49
  SPEAKER_00: But it's a good way of kind of starting the conversation.
• 35:52
  SPEAKER_02: Wonderful.
• 35:52
  SPEAKER_02: Well, for everyone listening, if this episode changed how you think about who actually gets into a clinical trial, subscribe to the clinical realist whenever you get a chance and wherever you get your podcasts.
• 36:02
  SPEAKER_02: And if you're working through a live clinical AI or research infrastructure question inside your own organization, not a theoretical one, a real one, the link to Book of Discovery and Clarity session is in the show notes.
• 36:12
  SPEAKER_02: I'm Dr.
• 36:12
  SPEAKER_02: Sarah Matt, and this is the Clinical Realist.
• 36:14
  SPEAKER_02: We'll see you next time.
• 36:15
  SPEAKER_00: Bye.