Breaking Down Geographic Barriers in Clinical Research

What if patients could participate in clinical trials from their living room instead of driving hours to a site? Tyler Van Horn, CEO of Science 37, explains how their direct-to-patient site model works. With one site covering all 50 states, Science 37 sends research-grade nurses to patients' homes, ships investigational products directly to participants, and uses telemedicine for investigator oversight. Tyler breaks down how they maintain quality (they've passed three FDA inspections with no findings), manage the logistics of home visits, educate sponsors on this approach, and create a high-touch patient experience that leads to better retention rates. If you've been curious about how decentralized trials actually work in practice or how to reach patients in research deserts, this conversation is for you. 

Transcript

Jimmy Bechtel 0:01

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest insights, trends, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Chief Site Success Officer at SCRS. And I have the pleasure of being joined today by Tyler Van Horn, the CEO of Science 37. Tyler's here today to discuss how, science 30 seven's direct to patient site model removes some of those geographic barriers and expands trial reach by bringing research directly to the patient's home. He's gonna share a little bit of insight on how this approach helps sponsors. Access more patients, enroll some of those hard to reach patient populations, reduce no-show rates, and really maintain quality and compliance throughout the study. So before we get into that, Tyler, I'd love for our audience to hear from you and learn a little bit more about your background.

Tyler Van Horn 0:52

Yeah, Jimmy, thanks. Thanks for having me. really excited to be on the podcast today. happy to give some background around myself and kind of could give a high level overview of Science 37. name's Tyler Van Horn. I am CEO here at Science 37. Been in the industry for a number of years, was in large CROs previous to this, and kind of started my career actually in the banking industry, evaluating, and looking at, biotech and, early investments. And so, kind of come full circle as, as an operator and kind of come into this, this world. science three seven is a incredibly. Unique organization. You know, it's had its evolution over the years, but, at its core we are a clinical trial site. we might do things a little bit differently than a, traditional clinical trial site as everyone kind of thinks about it. We don't have a clinic, we don't have exam rooms. We don't have a facility other than our headquarters in North Carolina. we bring research directly. To the patient, which most of the time means either out of, local, care facilities, but most of the time, outta the patient's home there's a lot of complexities that we can dig into, how that works and all the mechanics behind it. But, we're essentially one site, one set of regulatory documents, but we cover the entire us. So the entire country, we can see a patient wherever they might be.

Jimmy Bechtel 2:08

Excellent. Tyler, thank you so much for the overview there. And it's always really interesting, to be exposed to and talk with the Science 37 team and their really unique take on patient recruitment and clinical trial execution. So let's dive then a little bit more specifically. Can you give us a little bit of an overview of the direct to patient site and how it's changing? and maybe how it's different from the way that normal clinical trials are conducted.

Tyler Van Horn 2:36

Yeah, absolutely. So, I mean, let's start with how clinical trials are conducted today, and then we can evolve into the direct patient site model and how we're kind of changing the perspective and approach. typically today you have your site selected, at any given location typically there's a 30 mile radius around that given site that patients are either, recruited from or they're coming to that practice for their, standard of care. Right now, there's, a vast majority of the population that doesn't have access to clinical research. and when you get into the mechanics of it, a site in where we are here in North Carolina. People are probably willing to drive further than say, LA or New York. that geographic radius shrinks considerably. Also just from a convenience perspective, a lot of protocols and the complexity of clinical trials. Today. they've increasingly got more complex, but the number of visits has largely increased per trial. and as part of that, that means that any given patient in a participant in clinical trial has to, has to attend a site more often, and either take time outta their day, whether it's work, and or if they're, a caregiver for a family to be able to go and actually participate in clinical trial. Science 37. So we, we disaggregate the geography from clinical trials. So what does that mean? we are a site, we have 1 set of regulatory documents. All of that is managed centrally. our investigators have broad licensure. most of them have 48, to 50 state licenses. Some of them have, smaller set of state licenses specifically to like a, geography, so coast to coast. we have a team of CRCs that coordinate all of the visits, all the backend logistics associated with it. We've got a whole logistics team that also supports to be able to ship things to patients' homes. we ship IMP directly to the patient's home. And then we have research grade nurses. And this is a really important distinction'cause these are all our employees that are going into the home and being the eyes, hands, and ears of the investigator while the investigator is providing oversight via telemedicine. And so everything is a fully encapsulated site. the difference is, is that you can participate in a clinical trial from the comfort of your own living room versus having to commute back and forth to a site. So, in that 30 mile example that I gave previously. 30 miles in, you know, where I live here in North Carolina, could be 30 to 45 minutes, depending on the time of the day. You know, the patient gets that time back It's more convenient for them to be able to participate ultimately leading to, higher retention rates because we're very flexible with times that we can actually conduct a visit. Meaning that we can do weekends and we can do other times as well that are more convenient for the patient. And so being able to fit into their life is really important. And so that's really what we do and how we do it to make sure that anyone and everyone can get access to a clinical trial. example of this is we have patients enrolled in studies now, that are in Montana and South Dakota. and then we have some that are enrolled in more, metropolitan areas. it just Varies greatly. But we do a lot of visits all over the country on any given day. ultimately most of those visits are conducted in what I would. Called research deserts. So where, where sites are not.

Jimmy Bechtel 5:35

That's excellent. Tyler, thank you for that comprehensive overview. It's really interesting to hear, not only the similarities, I'm sure we could, and so can the listeners draw parallel lines to the more quote unquote traditional site experience, but also more importantly, the. Difference is the augmentations to the traditional site model that enable some of the things that we had mentioned, right? Quality and reaching those patient populations, The convenience of being in one's home and being able to participate in a clinical research study through, the enablement of technology and the platform that, science 37 has is really interesting and, intriguing way to approach. The execution of some of the work that we're doing and, and again, meet the particular need of a patient who might not, prefer or not be indifferent about being, you know, being in person with somebody or, or having that, in clinic type of experie.

Tyler Van Horn 6:27

Absolutely. I mean, the day and age that we live in, especially in a post COVID world where many folks were trapped in their homes for months on end, largely is around convenience. And that extends to the healthcare space as well. You know, the rise in adoption of telemedicine more broadly and the use of that in kind of standard medical practice, has really kind of driven more adoption and I think more of a. Openness to, to the approach. You know, and it's really, I don't want to, oversimplify it, we're doing a lot of very complex, assessments out of patient's home. We've done 60 hour infusions outta the patient's home. We've done, in a phase two Parkinson trial, UPRS part three outta the patient's home. So it, it, it, and we've done spirometry out of the patient's home and extends much further than just what you would think of a typical home visit, And a lot of these clinical trial visits are incredibly long. a six hour visit in a site, is a lot of time to spend away from home and your family And so that convenience is really important to patients.

Jimmy Bechtel 7:23

That's great. Tyler, let's talk about that concept that right, this new way of thinking and, maybe shifting how we've traditionally done things because we know that this is probably a new model, or at least a model that hasn't had a lot of exposure for a lot of sponsors. So how do you. Guide them through the adoption, help them understand what needs to be done there, and really, I guess more importantly, support any shift in design and planning to meet the needs of, really enabling this kind of, I guess we'll call it what it is, right? This totally decentralized, way of execut.

Tyler Van Horn 7:58

Yeah, it's a great question because it's a very, involved process and there's a lot of engagement with sponsors, either early on in, the study design or, going through site selection. And a lot of the studies that we come in as well, we're coming in the middle of the study as the ability to boost enrollment. it largely depends, but, a lot of the, a lot of the discussions specifically with sponsored, there are some things that are unique with our model, but, 99% of the time, we are just one site of many on any trial that we work on. So if you have, 14 sites from the trial, we're the 15th site. And so it's, we're, we're fit right into kind of the. The existing infrastructure that is already there to conduct a clinical trial. there are some nuances and differences. for example, we can't, randomize and, do baseline, or dose on the same day. Because we have to ship drug to the patient's home. there's some nuances in the way that the trial's set up and the downstream ramifications and impact on that. The other thing is, in a given screening visit, we typically separate out their consent visit and do a telemedicine consent.'Cause we don't wanna deploy a nurse to the patient's home without a patient actually being interested and willing to. Participate in the study, otherwise you have additional costs associated with it. So we try and avoid that on behalf of sponsors. But everything else is going to be largely education around, individual mechanics on how things are done. So, for example, we tend to get a lot of questions around, IMP accountability and how that's ultimately. Distributed to patients in a compliant and effective way. Where there's not a lot of tampering. And so we go through and explain the process end to end on how we use a central pharmacy that has 50 state licensure and shipped to patients anywhere. How does a nurse get deployed to the home? What does the experience look like for the patient? what can they expect? how is the data collected? How are the assessments. Done. A lot of times what we do, especially when a sponsor has particular questions in their medical team in particular, has questions about how, an actual visit looks, we will go to the sponsor's, place of business, either their headquarters or one of their offices, or they'll come to us, and we will actually do their clinical trial visit right there. With them. and show them either a screening visit a day one visit dosing visit, or any given visit of their choosing to show what that experience looks like, and get them comfortable with how that it is actually being conducted. one of the biggest benefits, at least that we've seen for ourselves in the last 18 to 20 months is that we've been inspected three times by the FDA, A handful of pivotal phase three trials. And, you know, these were all registrational studies and, going through that experience as well where we had, no action indicated. So there was no, findings or recommendations from the agencies provide a lot of credence and frankly, a lot of confidence with sponsors in the model and the data that's actually coming out. On the other side. And so, a lot of engagement on that side. And then as we go through startup, there's also, a, second round, I guess, of what I would say education or kind of what another way of putting it would be onboarding to the Science three seven kind of model. Where, you know, normally the folks that might have selected us as a site. Aren't always the folks that are going to be executing day to day. we have a pretty clean and consistent process in which we can not only, educate the folks that we're engaging with, that are looking to stand us up as a site, but also the folks that are gonna be, day to day, whether it's the CRAs or, the individual study teams that are managing the study to be able to help support them in understanding what we do and how we do it, and what the differences are. So. We start enrolling patients into any given study that they can, have a better understanding of what they're ultimately gonna see and how things are gonna operate.

Jimmy Bechtel 11:29

Those are great examples. I really appreciate the nuance behind, all the different ways, that you guys approach this with your sponsors, to really help them have assurance that this is gonna be, a great way to execute their clinical trials, but also just that I think it's so important that it's one of those things where. It's like, Hey guys, we've done this before. We kind of know how this is gonna work. And so working in partnership with them to help them, again, design the clinical trials with some of those nuances that you provided in mind, I think is really Important. So then shift gears for me, Tyler, and talk a little bit about participation and what that looks like for patients and caregivers. When visits are happening in their home, how do you ensure. they receive the same level of support and oversight that you might experience in a traditional onsite visit?

Tyler Van Horn 12:16

Yeah, it's a fantastic question. I'll start with the experience when someone, raises their hand and is interested in participating in a trial. They're either going to, interact with one of our, CRCs or our medical team, or they're gonna come through our website and prescreen for this study. So they can either do it, via phone call or they can do it, online as this self-service portal. if they qualify based on the prescreening questions and going through that and some of their. High level medical history, they're going to release their medical records, to us to be able to actually review and qualify qualified patient. That's an incredibly quick experience. We have a, really sound operation on that, and it's really important that we're quick with that experience because, folks don't like to wait around. once they go through that, they're gonna get scheduled for their telemedicine consent where, our CRCs and investigators are going to spend time with them, walking them through the. informed consent and go through the trial and what the expectations are and, risks and benefits and all the things that you would expect from any given site. one of the biggest things that we have found to be incredibly beneficial as well as that we pride ourselves in is even a consent or screening or any other study visit. Typically our investigators spend, between 30 to 50% more time with each one of our, participants in the trial and our patients, than if you were at A trial site. when you ask a question around oversight, our investigators are heavily engaged. It's a one-on-one experience. they get to know the patient, very intimately, very differently than otherwise you would think.'cause we're in their home. Their dogs might be there, family members might be there. We are, when you talk about, con meds and actually looking at, the medications that patients are taking, we can see that they have their medicine cabinet that we can go and ask them questions about, and so we can get a little bit deeper and build more of that relationship there that otherwise wouldn't have been. And so, once I've completed it, going back to the kind of journey, they complete the, consent visit, and then we move into screening and, baseline day one visit, dosing visit, and then throughout the rest of the schedule of assessments. But, it's a very high touch experience. every visit is scheduled by our centralized scheduling team. prior to the visit, our CRCs are in, constant contact with the patient, making sure that the IMP showed up, that the SU supplies showed up. We also are tracking all that on the backend, but making sure that they know what to do with those things when they do arrive in their home, where to store them, things of that nature. Including, all of the, Supplies that are ultimately, shipped out, making sure that they know, not to open the boxes. It all has tamper proof tape on it, but not to open the boxes and where to put them. then when they get to the day of the visit, the nurse is traveling to the patient's home. The nurse is going to call the patient the day before, kind of again go through what to expect. when they're on their way, they're gonna call them and say, Hey, you know, this is, nurse Jane. I'm, 30 minutes away, I'm gonna be pulling up in a blue Chevrolet. we will, start with, getting on a telemedicine call with our clinical research coordinator to go over expectations and what we're gonna do for the day. And then the nurse sets up, their environment where they need to be able to, process any samples or things of that nature. The patient themselves is sitting in their home, and they're very comfortable with that experience. As they go through the visit, typically, we are, consistently the investigators either coming in and out of the visit and or spending a lot of one-on-one time with that patient. And so it, it's a very high touch model from end to end. And this happens at every single visit That we ultimately do within our model, and every patient that's enrolled. And so, we are, a little bit more hands-on than, than you would expect, but, it's, it's ultimately, yields, a, a better retention rate and ultimately a better, satisfactory rate from our patients and the experience from the clinical trial perspective.

Jimmy Bechtel 15:55

That's excellent to hear. And I can imagine where that. Type of situation would yield that. It seems very intentionally and probably as you're indicating valuably, so high touch for this audience, when again, we're working through these things where we're in the patient's home, right? It's a little bit nuanced and it's not the typical medical experience that a lot of patients have come to become accustomed to. So. Providing that level of high support and managing those expectations of the patients and the community, and of your staff. It seems very methodical and thought through, which I think is really excellent approach to that. So thanks for breaking that down, for us here. So I want to jump into Our final question here, Tyler, and talk through a little bit around, the process, the operationalization rather from startup all the way through to monitoring and how you manage staffing and training and, getting to the point that we made earlier around maintaining quality and regulatory readiness. I'm kind of circling back to that point you made where. You had those three recent, inspections, which I'm sure you all are an easy target for inspections because it's atypical here. But it's great to hear that you pass those with relatively flying colors. So again, talk to me about. How you maintain that quality and keep those studies moving forward and those patients maintained.

Tyler Van Horn 17:12

Yeah, absolutely. So it, you, you're a hundred percent right on the, the inspections and we, we approach, you know. Quality in a, pretty rigorous way across how we're starting up a study, what monitoring looks like, all of those things. The inspections that we've been through have been, rigorous and we've been through three of them in a relatively short period of time. And like you mentioned, we're an easy target for two reasons. One, we're atypical, like you mentioned. The second is that we're typically, the highest enrolling site, because of the geographic access that we ultimately can, can yield and, ultimately enroll from. And so much bigger patient population that we ultimately can enroll in the trial and ultimately, have access to. But when we come to kind of thinking about operationalizing, a trial, our startup is, pretty involved because not only we're doing what you would have at a typical. Clinical trial site, but we're also setting up all the logistics to be able to support the trial. So everything around, inventory management, getting, we have a central, logistics depot where we are shipping out all the supplies, the study supplies for both the nurses as well as, the lab kits and things of that nature, or any devices, spirometers, EECG machines, things of that nature, upscales, whatever it might be. and so we set up all the logistics for that. We have, the central pharmacy set up, so that's heavily engaged and involved. And so there's a number of things that kind of have to happen before you can start enrolling patients in any given trial. The rest of the process is rather standardized. Obviously, the things that change. Trial to trial or the, is the patient population and the nuances there, but also, the assessments that you're ultimately performing from trial to trial. So, there are nuances to start up, but again, it's a very engaged process with sponsors to help walk them through step by step what's going to happen and what's different. We make sure that everyone's onboard and really understands the model itself. we don't have any paper. we have eSource, EISF, all documents are stored there. All data is collected in our eSource. and what that allows for is, every, person that is, on the trial from a staffing perspective can see and access the data in real time, and collaborate together, in real time for collecting that data for the patient when they're completing the assessments. When someone's onboard into Science 37, they go through training on our SOPs, but they go on a pretty rigorous training on the Science 37 way, which is, how we conduct research, what's different, and ultimately, what are our expectations and standards, For the participants in any given trial, but also from a quality perspective. Then obviously at any given trial, we go through protocol training and study specific training for all of the staff. And especially for our, research nurses that are going and traveling to the patient's home, there's a number of certifications that they ultimately have to get to be able to transport biospecimens and things of that nature. And so all of those things Are taken care of. and so from that perspective, there's a rigorous amount of training that goes on from a study staff perspective, and we maintain all of that in our, training records, as you expect on the other site too. we also have an internal team where, we are not only just relying on, sponsors or CROs to monitor us, we are doing asynchronous monitoring visits, internally, existing kind of cadence and monitoring visits in the study. at any given point in time, whether it's particular milestones, enrollment milestones in the study, or if there's, specific triggers or kind of thresholds, we have a team of internal, crass that are looking at, looking at data, looking at our EISF, ensuring everything is, as expected or as it should be. So that we're approaching those monitoring visits, with relative ease and also that makes it so that we can stay inspection ready at any given point in time. we are very proactive from that perspective, which has led to, you know, three obvious, you know, successful outcomes from a inspection, FDA inspection perspective, which we're incredibly proud of.'cause we're the, we're the first kind of. Company in this space to be able to have that not only once, but three times to go through those types of inspections with, with the FDA. So it, you know, that that's the kind of approach and it's a really proactive approach versus reactive approach to, to how we maintain quality and how we maintain oversight and things of that nature. within our existing kind of model and how we approach everything. And so. That there's a lot to unpack there, but that's the high level of how we approach and make sure that we can be consistent, trial to trial with maintaining that. And you know, all the folks that we have here, we're very diligent about who we bring on to Science 37, simply because we are different and we wanna make sure that we only have the highest

Jimmy Bechtel 21:32

standards. It is an excellent overview, Tyler, and I really appreciate the detail on, what arguably is one of the more important components to that. Because if we don't have quality and we don't have, the ability to maintain the ethics and the regulatory readiness behind it, then seeing patients, can't happen effectively. So it really is foundational, which I appreciate you emphasizing that. Approach to the way that we do things. it sounds like, it really ingrained into the work that you all do. so thank you for that. And, you know, thank you for being here with us today and giving some insights to the industry and what you all are doing and the approach that you all are taking. I think, even our more traditional sites, probably we're able to glean some insights into. Maybe I should think about doing that, or maybe that's a consideration that I should have as I approach my patient care or my quality at the site level, or the relationship that I have with my sponsor and CRO. So, I think everybody listening can probably glean something from the conversation today. So again, thank you for being here with us. and thank you for sharing, some more about your organization and the model that you guys use.

Tyler Van Horn 22:32

Jimmy, I really appreciate you, having me on. it was great to talk about all the aspects of it. I'm sure we could have talked for another two hours about, individual items or dug a little bit deeper, but, really appreciate it and, you know, always, looking for different ways to partner with SCRS. It's a great organization and, we're happy to be a member and partner and, looking forward to continuing that journey.

Jimmy Bechtel 22:53

Well, I couldn't agree more. Tyler, thank you so much and for everyone listening, I hope you make sure to check out other great sites focused resources made available to our entire community on our website, my scrs.org, including other podcasts and webcasts, and opportunities to become involved with our partners like Science 37 and many others. Thanks for tuning in for listening, and until next time.