Inside the Mosaic of a Site Network in Clinical Research w/ EB McLindon

EB McLindon shares his extensive experience in clinical research, discussing his journey from finance and technology to building clinical trial sites. He explains the various models of research sites, the role of a CEO in a research site network, and the dynamics of competition and collaboration among sites. Our discussion covers the importance of patient recruitment, the challenges faced by sites, and the potential for technology to enhance communication and efficiency in clinical trials.

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Transcript

SPEAKER_02: 0:00

Even if you just sit in the waiting room for 30 minutes, you'd be surprised at what you hear and what transacts. But I do think everyone's talked for years about patient voice and site voice. I think that's the site voice. The site voice isn't hearing them complain about a tech or complain about a delivery or lack of delivery. It's actually going to the clinic and understanding what they have to go through on a given day because stuff changes.

SPEAKER_00: 0:36

So who is EB? And what do you do in clinical research?

SPEAKER_02: 0:39

I'm a bit of an enigma because of my initials, but the research story started for me about 20 years ago. Prior to that, I've been in finance and technology. After the last 20 years, I've been building clinical trial sites. So I started off with a company that I helped found called Accelavance and was there running that for about 10 years and on the operations side, and then moved into Icon and helped build what's currently called AccelaCare over there. And then a couple of years ago in the second half of 2022, we started And I think I've always been enamored for some reason with patients and doctors and building clinical trial sites has been something of a passion for mine, certainly over the last 20 years.

SPEAKER_00: 1:19

You spent a long time in your career and you said a long time, not me. I'm repeating it. Starting with research sites, then you go to tech, then you're in the CRO, then you're back to research sites.

SPEAKER_02: 1:31

Why the round trip? I started off in technology research. and and spent years there didn't have as much gray hair back then and and then when i got into research like a lot of people you don't know how you get there suddenly you wake up and you're in research and it was pretty cool and then if you think about Now, 20 years ago, the tech then versus the tech now is substantially different. So I think my early career helped me understand enough to be dangerous about how to use technology to be more efficient and effective. And then the round trip within that last 20 years has mostly been the passion for patients and doctors. That's where the data is made. And when you're down at that level, you just get a much different level of appreciation for what patients go through and how physicians support research. on a day-to-day

SPEAKER_00: 2:18

basis. So you're a CEO of a research site network. I think a lot of people know what a CEO does, but actually I think there's still a lot of confusion and hopefully we can unpack that for people today on what a research site is, what a network is, what are the different sort of iterations of that. But how do you describe your job as a CEO at a research site network?

SPEAKER_02: 2:39

Yeah, I'd say it's glamorous, but it really isn't. It's really the last, I mean, to be honest with you, today I'm doing the same things I was doing 10 years ago, which is fun. I I mean, really, you're doing a lot of different things. You're wearing a lot of hats. It's probably no different than the day you have where you can start off with an internal call about sales and then have external calls with sponsors and CROs. And then you're right back into an internal call trying to solve some sort of problem. So it's, again, the glamour in it is getting to the finish line, whether it's at a study basis level or a project basis level. And any given day, it's a little bit about problem solving. It's a lot about strategy. And it's really a lot about trying to figure out how to grow in a market that's been very challenging. So both growing your brand while at the same time you're trying to grow your network.

SPEAKER_00: 3:28

I do know there's probably a lot of listeners we have that understand what a research site is. They've been working in clinical research, but maybe they don't know all the different variations of a research site, right? All the different options that are actually available. So can you just do a quick explainer? What are the various research site models that are available in today's clinical research?

SPEAKER_02: 3:47

Yeah, so I think... I think if you went out and whether you Google it or go to ChatGPT, you're going to get about somewhere around 10 to 12 different types of clinical trial sites. And some of them have been around for years and just tweaked their models here and there. But you get everything from the physician-owned independent clinic, which a lot of people are familiar with, where a physician has a practice in a specialty CNS or GI or something like that. And then they decide to do research and it's side-saddle with their practice. And that's a lot of the sites out there And then you have from there, that's when it gets interesting. So then you have affiliate networks where no one owns each other, but they're affiliated maybe through branding and business development or through back office. You also have site management organizations, which is a variation of that, where they provide strong kind of back office support, but then they might also provide coordinators. Then you start getting into network models where you have integrated research organizations, which tend to, they tend mostly to focus on healthcare systems or large large roll-up organizations. You also have integrated research, like integrated site networks. You have AROs, academic research organizations. And so what ends up happening, I think, is a lot of people get lost in the taxonomy of these and they focus so much on what you are as opposed to what you deliver. I actually had a situation about a year and a half ago where our network got disqualified from an RFP. We went through the entire RFP process. And when they came to us with the outcome, they said, oh yeah, at the end, we disqualified you because you're not an XYZ. And I said, okay, what's your definition of an XYZ? And they gave it to me. And I said, well, we do all of that. And we showed you in our proposal and our slides that we do all that. And they're like, oh yeah, you're right. So I think people get so caught up in that rather than what patient are you going after? Where does that patient get their healthcare? And where are they willing to go get their healthcare? Because a lot of patients are willing to go to a dedicated center, even for some sort of chronic disease. But it's like, where Where are they going for that healthcare solution? And is there research there?

SPEAKER_00: 5:52

If you think about like this definition of a site evolving and changing, and I didn't know that there were 12 versions. And by the way, if you did put them in chat, GPT, you and I both know what would happen. you'd get a reading back, lots of em dashes and like an icon, a rocket icon for all of them, right? And so just for everybody listening, before you go post on LinkedIn, please remove the rocket icon. Then we just know that you didn't write it. So let's say you put all those in and the next question you ask ChatGPT is, do these sites partner? Do they compete? How do they work together in the model? So what would the answer be?

SPEAKER_02: 6:25

Yeah, you'd get a little bit of both, right? First off, I think there are a lot of different definitions only for differentiation. A lot of people are trying to kind of strike out they don't they don't want to be called one thing so they they define themselves as something else which is which is great i mean again some of that's market uh driven i also think when you look at partnering or some sort of affiliation things like that i think it was easier it was It was competitive, but probably friendly competition pre-COVID. Not to bring up the PC word already, but in pre-COVID times, networks, we would go to conferences and I can openly share an opportunity because I knew that if you were the CEO of another network, I knew where your sites were and I knew you weren't... It's okay. You're not going to take any of my... of that larger scale phase two, phase three study. Now there's so many networks out there and they're brought back by private equity. So they're popping up sites. They're acquiring some of these independent groups. They're sewing them all together in a platform. And suddenly you look around and you even Google yourself and you're like, well, they're like five or 10 sites right near the clinic. I thought it was so special. And so you suddenly become a little bit more protective because when you're backed by private equity, you have to hit numbers. And so you're trying to be protective of that. I think where a lot more collaboration happens, and there's some groups that are really good at this, like SCRS is the best example, I think, where you get a group like that and it's a lot of learning. It's like, how do you help other groups learn how to negotiate a budget and things like that? So I think the collaboration might be more functional and operational and less deal trading like we used to do, but I still think the site community... is probably the best community for sharing. People want people to be successful for the most part.

SPEAKER_00: 8:18

One of the things I've heard from people, right or wrong, and so I think I need you to debunk this or just back it up, is that when you add site networks and some of these new network models to studies, you're actually decreasing the number of sites on a study overall, meaning you put a network in, and so if I was going to select 20 investigators in the U.S. or 20 in Europe, I'm now going to select 10 because the site network is going to take the place of the other 10. On the average, is that true? Is that just what people think happens competitively?

SPEAKER_02: 8:48

Well, I think, so it's true. And as a matter of fact, it's funny because I hear some folks say, pitching that today and it was something we were doing at Excelevance and So I mean, again, it's like the hula hoop, here we are. But I will tell you, John, it's true. And I think it's also indication specific. So you're not seeing that in oncology and rare. You're seeing it certainly in gen med, certainly in vaccines where you need less studies from the population, where you can actually get a multiplier off some of these larger dedicated clinics. Absolutely. I also think that there are inside larger TAs and indication less studies level, like a CNS as an example, where there's some CNS studies where you can't really leverage it like that. But there are other indications within CNS where, yes, you can get a little bit of a factor off of some of these network sites so that you don't have to pull in as many. And they're certainly selling it. They're selling it as a value add. And I think for the most part, and this is the part that might be a little mythological, is that they're They're also giving a discount, right? So if a network comes in and says, look, I've got 20 sites that can knock the cover off the ball, I'll give you an X percent discount if you take all 20 of them. I think there's some of that happening also. And again, there's value in that for the pharma sponsor.

SPEAKER_00: 10:12

So when you talk about knocking cover off ball, for those of you who don't know, that's a baseball term. go Giants. And if you think about what that looks like, what is that for a high performing research site? Like what is knocking the cover off the ball? And here, let me tell you my two cents. My two cents is it's always been about recruitment. It's always been about recruitment, right? Does the site have the right patients for this protocol and do they feel like this is what they do all the time and they can recruit these patients and take care of them through a study? But now it's interesting. I was with a friend who also manages the site and the terminology he was using sounded so similar to what I use when I talk about like contrasting from a technology firm to a technology firm, right? Where we, you know, not feature to feature, but like We as a technology company do this and this is why we're different. What are those things besides recruitment? What are the things that are differentiating or contrasting a site from another site? So they're winning the work and someone else isn't.

SPEAKER_02: 11:08

You probably have to ask some biopharma clients that because they're the ones that are, they're the buyers for the most part. I think it comes down to a couple of things. You know, to your point, first and foremost, it's about patients. If you deliver the patients you say you're going to deliver, that's that repetitive process is what it is. It's, I mean, coming back to baseball, it's, you know, If you're striking out all the time, your coach is going to bench you. The biopharm is going to bench you. It's just not going to happen. But I think there are a couple other factors. I think first off, it's speed to start up. So it's not just recruiting the patients, but can you get your study at a clinic up and running fast so that those patients can start accruing into the research study? I've always said, and I've said this for a very long time, that really good sites recruit patients, but the best sites complete patients. I mean, you know from the data side, right? Let's just say, for example, there's the phase two study you're going to put 400 patients in. You know, the statisticians already factored how many folks can drop out of that clinical trial in order to get that complete data set. Well, if you're a clinical trial site and you're, you know, let's just keep it simple, you're going to put 10 patients in, but you only complete one of them. You only get full data set for one of them. You've left that sponsor high and dry on those nine other patients. So the focus is, again, is not just driving recruiting, it's engaging the right patients to make sure that they fulfill their obligation to study, which will help you fulfill yours. So I think there's speed to start up at the front end, which a lot of the networks, they manage that through central solutions like reg, your turnaround and contract turnaround, things like that. But then you look at the execution, recruiting, yes, but are you recruiting the right patients to get you that complete data set?

SPEAKER_00: 12:49

When you work in clinical research, especially on the CRO side, a technology vendor side, you're sort of building Yeah. Yeah. you learn something new, right? You see the real world and you see the fact that some of the things you work on don't come together perfectly. And there's a lot going on, right? And so I have a, you know, I think a different level of respect for sites, especially study coordinators, just knowing what they do every day and understanding the complexity of their job and how that's sort of moved to the next thing, moved to the next thing all the time. Let's say you're talking to somebody who has, worked in clinical research, but never actually been to a site, never actually seen a patient. What do you recommend they do to really understand that part of business so they can apply that to their thinking into their job, regardless of where they were in clinical trials?

SPEAKER_02: 13:56

First off, it's a great question because I think there are a lot of people that can conjure up in their mind what a clinical trial site does without ever having to being in one. So there are a couple of things. One is, total side note, I saw on LinkedIn, speaking of LinkedIn, that somebody followed a coordinator for a day and they're like, that's the hardest job I've ever seen. So there's a lot of respect for coordinators. I have incredible respect for anyone at a clinic, from the site manager all the way down and back up again, because what they deal with in a given day, you can only imagine. I mean, they're dealing with people and they're dealing with physicians and they're trying to sow the two of those people together. And they're dealing with data and monitors and technology. and technology changing and passwords changing. So there's a lot that goes on. At Accelivance, we actually had a site near our headquarters and part of our orientation process. I didn't care what role you had, but you spent a half a day in our clinic to kind of marinate in that feel. And you could feel kind of what goes on in a clinic in a half day. What I would tell people, if you haven't been to a clinic, Google your area. I bet you there's a research center you could drive to. Call them up and say, look, I'm from this company. I want to pop in and just observe Even if you just sit in the waiting room for 30 minutes, you'd be surprised at what you hear and what transacts. But I do think everyone's talked for years about patient voice and site voice. I think that's the site voice. The site voice isn't hearing them complain about a tech or complain about a delivery or lack of delivery. It's actually going to the clinic and understanding what they have to go through on a given day because stuff changes. We're all human beings. Human beings make mistakes. know some of the mistakes are made by the patients and the sites there to help the patient kind of come back into the clinic and make sure that that everything's okay so i don't have a good answer other than google it and and go i think i mean like if somebody googled one of our clinics and was like hey look i just want to pop in and i mean obviously we'd have them sign something but like just come in i mean we love to open our doors to people so that they they have a better understanding for what it is that happens inside a research clinic for a research study.

SPEAKER_00: 16:07

I'm pretty sure I was one of those people you made go into one of the clinics. I think so. At some point. I'm pretty sure I was, which is good for me. You know, I think we need to be careful. So everybody in clinical research, don't go sit in everybody's lobbies at our research site. Yeah, don't

SPEAKER_02: 16:21

stalk them. Yeah,

SPEAKER_00: 16:22

call it. But I do, I think there's something so important to that, right? Is that we, just like we see in patient research, and we've worked really hard to not believe we're the patient and we're really not, and sort of making decisions and not listening and co-creating with patients, we make a lot of assumptions, right? And we just assume, wow, that's how sites work. That's what they care about. Every time I ask those questions, and we ask healthcare professionals, study coordinators, those questions, all the time, every time we do, the answers we get back are usually different than how I think. I think it's an important reminder for us to keep that. But listen, the flip side of this is you did bring it up, this kind of terminology around, you said the word complaining. I'm going use the word tension. Because I do think, you know, if you log into LinkedIn, if you, you know, sort of listen to conversations, you go to conferences, you can hear tension when it comes to research centers, site networks, or research sites working with different stakeholders in research. And maybe that's mostly for LinkedIn clicks. And I do kind of believe that to a certain degree. But I also live in the real world where tension is a part of business. And so I What's the tension between sites and CROs, right? And how do you overcome those to be more efficient together? How do these groups work together knowing they have maybe some different business objectives? But how do they make that work? Because they've obviously been making it work for quite some time.

SPEAKER_02: 17:43

Well, maybe they go visit sites more often. I think, you know, so it's, look, to your point, I think, for good or for bad, the advent of social media, I think 2012 was the tipping point. We've talked about that before where like suddenly now everyone, everyone has a keyboard and has access to the internet. So I'm just going to lodge my complaints festivus for the rest of us. But I think when you look specifically at a clinic level, I think the learning has to go both ways. So let me make that a little bit more clear. We just talked about going to visit a clinic so you understand that better. I think there are a lot of sites out there that don't understand or don't really appreciate some of the decisions that biopharma has to make on a day-to-day basis. And then the downstream to the CROs, they have to make decisions based upon shipping cycles and IP viability, but also technology and what's working, what's not working. So I do think the learning can go both ways. And I've done what I can specifically inside Helios to say, hey, look, we also have to understand that there's other things going on know for the sponsor for the cro specific to the tension i think it comes back to the same numbers that we always hear which is at any given time well a trial running at a clinic probably has 10 different technologies and there's all these passwords and then there's a reliability that there's an 800 number for the patient to call but the patient always calls the site so that's one kind of you know fork in the side of of the site level because they're like hey look you know I have to know the technology well enough to support it and fix it at some level. I mean, obviously not programming, things like that, to make sure the patient is engaged. I also think that there's a lot of pressure in research. So look at the last two years. The number of studies is less than it has been. Studies are getting canceled and delayed for various reasons beyond a lot of people's control. And I think the pressure cooker that transcends from the sponsor to the CRO and then down to the clinic, and then there's that pressure, right? Look, to be brutally honest, in the last 20 years, this always flows downhill. It flows downhill and the sites are at the bottom catching it. And so that tension, I think some of it is good for, for the industry because you get innovation. You get things like embracing decentralized trials. You get things like embracing remote visits for the physicians so that they can see the patients in the clinic, but also have video conferences. I think you get embracing some of this new technology that way, but it does come with headaches. And I think the headaches are born, or at least the sites feel like they bear most of that problem, which I can understand. It's not like, you know, CROs and sponsors wanting to hurt them. You know, it just happens.

SPEAKER_00: 20:25

Talking about that tension too, if you take it and let's move it over to patient recruitment and patient recruitment companies. Yeah. What's interesting is I have friends, good friends that run and own sites. And I have good friends that are run and built patient recruitment companies. And somebody recently said, well, you know, sites, we don't like recruitment companies. And I went, what? When did this happen? And so like debunk that for me. Is that really true? Or is there some kind of a tension between the two that sort of makes that relationship complicated?

SPEAKER_02: 20:54

I might have started this thing 20 years ago. So the reason why I say that, I mean, honest to God. So you have to remember, my background was finance and technology. I came into research. And within five months, we were running our first multi-site study as we were a subset of sites on a phase two multi-dose. It was a five-dose vaccine program. I know it's a shocker, everyone, because I think most people just thought vaccines started during COVID, but they've been going on for a while with those dinosaurs. They have. So for us, we had eight clinics on this trial. And the trial was for... I'll just say it was for anthrax. I couldn't figure out why no one was like, we weren't getting any patients. It was a central campaign. We weren't getting any patients. I called the CRO and I'm like, there's something wrong here. We should be getting tons of patients. We had clinics in areas that should see these people. So they sent me the ad and it was, I don't know what font level that is, but it's like the size of my head. It said anthrax. So I could imagine people, now again, 20 years ago, people at bus stops, like just throwing the newspaper down because anthrax, This was in 2005. It was four years after 9-11. So I could imagine people running away from newspaper ads. Long story short is that I think the tension is that sites, network sites particularly, like sites that have a central group that does their recruiting for them, they feel like they know their city. They know their town. They know where they live better than some large... third-party vendor who lives in a different state and doesn't know anything about where they live. And to be honest with you, there's some truth to that. We've run A-B sampling on recruiting, and our recruiting messages ring truer to our patient population, whether it's in clinic, like through EHR, or outside of clinic through social media, better than a third party. I think some of it, they remember, like sites will remember that one time that the cancer patient was sent to them that had the wrong tumor type. They'll remember that for 15 years. They won't let go of it. So I think some of it is, is trust. You know, I think some of it is, is that is, is the models. There are actually some really good recruiting companies now where their financial models, they get paid for like screen, like actual randomizations, as opposed to just throwing people in a clinic. So, Hey, we sent this clinic a hundred people. Well, yeah, you send a hundred people that have no interest in research or they don't even understand that you reached out to them for research, which is also part of the disconnect. So I think some of it has been the modeling. And I think some of it also is there's sites that do it really well. So now go backwards. Earlier in our conversation, we were talking about go to the right site for the right patient. Maybe deploy these third-party vendor recruiting vendors to the sites that need the help and not everybody. Don't make it a one-size-fits-all. Make it optional for some sites that actually know how to deliver patients. And maybe that would help solve some of this also.

SPEAKER_00: 23:56

Yeah, it's interesting. I think this fit-for-purpose use case is always the understanding we use. And the A-B testing just still to this day shocks me because someone will, you know, just in my daily work, someone will come in and say, hey, we see advertisers doing it. We say, have you asked patients to actually review these? And they'll say no. And I'm like, doing? Like ask patients, they'll A, B, C, D, E, F test this for you and tell you what works in that region. And I think it's, you're right. When you're a site, you already have an inkling of what that looks like because that's your area, right? It's where you live.

SPEAKER_02: 24:28

Your point, I think it's good for purpose. I think one of the, one of the great things about research, which is also one of those downfalls is that if you can, if you can customize every solution, you'll deliver a great study, but it's hard to customize every solution where you're trying to go, you know, multi-site, multi-studies, maybe in the same therapeutic area you have, you're targeting four different indications like in cancer. Well, you can't do customized down to that level. You'll just be spending way too much money. And I think some level, some of these groups, the recruiting groups, they do a very good job. I just think that if they had a little bit more skin in the game, you'd find that they do a really good job for like independent sites and maybe some of these groups that don't have the central service already in hand.

SPEAKER_00: 25:14

When you think about a site too, a research site, regardless of if it's an individual site, a network, an SMO, an ARO, whatever that model is, we keep talking about different people that are servicing. Their job is to support the site so that they can recruit and take care of the patients in the clinical trial. That's the point. And we're talking about CROs and recruitment companies. There are lots of other vendors, lots of other companies we could talk about. And there's always tension there. I've grown up. In the last 10 years, seeing more and more tension between technology and sites. As you try to get that balance right, From a site's perspective, if you could just start a tech company and say, I'm trying to address these gaps that we see no matter who we're working with in the market. Give me like one to two nuggets. What's the thing that you and I, Evie, would go build to service that gap so that sites would feel even more supported or more enhanced by the technologies they use?

SPEAKER_02: 26:07

Wow, that's a loaded question. I think I'm going to hit two quote-unquote simple things. simple solution. And again, it could just be us. Half the time I look at it, I'm like, maybe it's just an us problem. But one thing that I know from having multiple Helios sites on the same study is that we go in and we'll ask a question And if site A asks it to a monitor, site B asks it to a project manager, site C asks it to their monitor, we might get three different answers. And so I know there have been many attempts to try to white glove these types of solutions. There have been attempts to centralize communication. I actually think there might be a chance now with the advent of AI to actually do a voiceover of what those answers are. I mean, to actually let AI develop kind of the FAQ for a study. And then it knows it so that when you call in, it's giving you a centralized standard answer for some of these questions, because some of them are obviously more complex and might need a little bit of a handholding, but there are a lot of them that are just kind of like pretty simple and it's hard to get a common answer. So that's, I'm trying to think of like new tech and maybe kind of a, kind of a little side thing there. So that would be one is there's a way to get a better way to communicate the front end going into the study, better questions and answers that are common and answerable. That would be one area. I think the other area, and this is something we've been, and I know you guys do it yourselves, is source is the single source of truth. But here you have us who like we use, resource. And then we have to go into an EDC system. That EDC system could be off the shelf product. It could be something that pharma has been using for 20 years, whatever it is. So we have to take our source and then align it into their CRF. Now we use CRF guidelines to, you know, to make sure that there's some alignment, but like all we've done is taking double data entry off of paper forms that you as a monitor used to mail in to a central office. Now it's just all it's done is distributed that workload to a clinic. So we're doing double data entry in our clinic. There's gotta be a better way to do that. And then you add a third element, right? Because there are a lot of clinics, especially when you start talking about you know, harder to treat populations with rare CNS and oncology, where you want to get some of those data points back into the medical record because it might intertwine with standard of care. So now you're taking data from e-source, putting it into your medical record and then back and then into EDC. And I know, again, I know there's some groups out there that are working on EDC to EHR and that connection or EHR to EDC and that connection. But really, it's the source that we need to figure out a better way to just use that as a unifying solution because that is taken it's taken at the visit it's the truth of what happened at that visit it seems to me that there's a better way to use that as opposed to then multi-layers of other data entry that all it's done has just been distributed back to the clinics

SPEAKER_00: 29:19

there's one or two things you know about me you know i'm not a fan of the case report form and frankly i've been on the tear for years to eliminate it yeah because i'm with you 100 i feel like source and direct data capture has been around a long time and it's coming because persistence wins in this industry, right? It's coming. But do all sites, research sites, feel the same way you do around, if I were to say, hey, there's no case report form, you're just going to direct enter here, and then we're going to get this back in your EMR there, and you're going to have less monitoring and oversight required, so we're going to get out of your way a little bit more. Is that advantageous to sites, or is there a component of that that's too far for research sites on the average?

SPEAKER_02: 29:58

Well, I think you just hit on something that might be too far for a lot of sites, which is everyone's like less monitoring makes sense but we want monitoring i mean to be honest with you one of the values of a site network is that most if not all of them i think like 99% of them are going to have some quality department that are looking, they're doing their own quality checks on data before the monitor ever comes because they want to show that they've got good quality data, which is again, a value of having a network. So I think if instead of you saying we're throwing monitoring out, I always look at it as if you can remote view data and reg as an example, then when the monitor actually does show up on site, they have much more meaningful interaction with the physician and the site team about their operations? How's the study actually going? As opposed to, I saw five transposition errors in the data or whatever. I mean, that's like easy, basic. But I think if you did a survey, which I would highly recommend you do, I think a lot of sites would be all on board for a single point of data entry. And then whatever happens, whether it's a data lake, whatever body of water it goes to, people get what they need out of it. And they can evaluate. Because to be honest with you, if you actually did that, and I won't be confused with a statistician, but I think if you're getting that data pumped in real time, and real time means different things to different people, but on a daily basis, the statistician is going to be able to flag what looks weird pretty quickly. I mean, the data scientists should, at a minimum, be able to go, well, here's something weird here. Let's go back to the clinic and ask them that question. But what it does for you is all of a sudden it starts letting you look across your entire study and really understand what's happening with your patient population. And you're more in tune with the rhythm of the study, I think, faster than you are when you do your regular data cuts. Because you're doing data cuts on, you know, here's the source data, but you're doing data cuts on something over here, you know? And so I think sites, look, the burden of, I'll just keep calling it double data entry because that's what I see it as, is, I mean, it's a real thing. And I think most sites would, they would appreciate a streamlined way to do that with monitoring that site so that they make sure that they're doing what they should be doing. Because you have to remember, there are a lot of independent sites. If you ask an independent site, not 100% of the time, but if you ask them how they manage their quality, they would tell you, well, that's what the monitor is for.

SPEAKER_00: 32:23

Yeah, I totally get that. Well, eliminate the CRF, reduce the monitoring, not eliminate

SPEAKER_02: 32:28

it. Yeah, you reduce that data, much of the data component, and then you look at You can look at more like problem resolution, right? And root cause stuff.

SPEAKER_00: 32:39

One of the key questions that I hear often, and I don't know if I've ever had a really good answer for it. So I've got a CEO of a site network. I'm just going to ask you. Is recruitment is so much of the challenge of getting studies up and running, right? So tech firms and companies like the ones I work for, you know, we typically get, hey, how fast can you start up? But the reality is we can start up as fast as we want. We still get into recruitment. You get the FPI rolling and recruitment is still your biggest driver. of delaying in clinical trials. And we all know all the metrics about how expensive that is, how much time that is, how much effort it is. We know that. What's the thing that could change that could help us recruit faster? Is there something that needs to happen or something that hasn't been happening in the last 30 years that someone hasn't done yet that could really help sites be free and give them more autonomy, give them more support, give them more funding, whatever that is that would help them recruit patients faster so that this research could be done maybe six months quicker?

SPEAKER_02: 33:33

Well, John, if I had figured that out, I'd be retired right now. So I think... you know, let's take a step back, right? I remember 2008, the focus of DIA that year was patient centricity, 2008. So here we are, 17 years later, we have more websites, we have more recruiting companies, we have more people talking about research, but the same percentage of physicians and the same percentage of patients participate. Now, to be honest with you, I thought a pivot point was COVID. Because I don't know about you, but finally, after being in the industry at that point for over 15 years, my family finally understood what I did for a living. But it was on the news all the time. And you could go to a restaurant. People would talk about pivotal phase three studies. It's like, wow, you're speaking my language. Well, then, unfortunately, obviously, a lot of things have happened since then that have kind of sour people or dampen some of that enthusiasm. But I think there's still a moment of education. I think that's what a lot of the groundwork that these site networks do very well is they bring patients in for biospecimen studies, a simple blood draw or a flu shot. Hey, look, you get your flu shot over here, try a research study. You bring things in for something that people know about. And then suddenly they're like, well, that wasn't so bad. I didn't feel like a guinea pig. I didn't feel like I had an X on my head and I was sitting in the corner all by myself. Like I felt like I was part of something interesting. And then when they actually have something where they need research, they're not afraid. And I think the more we do of that, the better we're going to be. And to be honest with you, I think the last five years of these site networks spinning up whether it's private equity invested or self-funded because they got some cashflow out of COVID. And so they're starting to rev up their engines. I think the more that this becomes professionalized at a clinic level, the more participation we will get. I think it's, you know, research is definitely professionalized at the biopharma level. It's definitely professionalized at the CRO level. And I think now we're seeing the advent of being professionalized at the trial site level.

SPEAKER_00: 35:49

Shifting gears a little bit to that term around patient engagement, patient centricity, Yeah. We knew that a lot of solutions need to be developed thinking about and being in the shoes of a patient and working as opposed to being a sponsor of CRO and working in. I'll admit, it happened to me too. It happened in my company. We spent so much time on the patient first that it overshadowed the critical role of clinical sites and how we thought about them. And so in our business, we really focus on the patient piece first. Then we moved to the site portal, another piece second. And just because that's what we had to do, But at the same time, it was a pretty common story, right? Where sites were saying, hey, listen, you're over-indexing on the patient. Come meet my needs. Come help me do this. And so tell us, EB, how do we as an industry understand be more balanced in this and still thinking about supporting the patient experience, but supporting and thinking about the site and the site as the user that is the conduit to the patient. How do we do a better job of thinking that way and acting that way?

SPEAKER_02: 37:07

Yeah. Again, it's not that it's a loaded question. It's like, where do you, to your point, it's like, where do you start? Right. So I think there's been, A lot of progress made in engaging with patients in protocol development, things like that, great. Engaging with sites, protocol development, that's great. I think maybe what we're tripping into here is the operations side, right? Let's be honest, the CRO doesn't want a site telling them how to run this. Maybe you do, but they don't. I think for the most part, right? And so like, what's the learning there? And I think if you had, even to start with a blank piece of paper and say, we're just gonna do 100% tech-based, research. Like all we're going to do, we're going to engage the patients directly. We're going to put them in, you know, to a site if we need them or the pharmacy, if we just need a blood draw or a shot or whatever. I mean, like if we just went to Nova with a blank piece of paper, to be honest with you, you probably end up kind of where we are anyway. I think, I think you'd end up where we are. I could be wrong because you still need at some level. And again, this isn't ubiquitous. So, you know, there are a chunk of studies where you can go decentralized. where you can do something like that, where you just take a blank piece of paper and say, how do we get this patient, like give them the Amazon experience of research, right? Or the Walmart experience, like, oh, it's in aisle four. Let me go down there and look. How do you give them that? That hits certain indications within therapeutic areas, but it's really hard to do a phase one oncology study that way, right? A vast majority of the studies, you still need that PI, you still need the site. So to your point, how do you work with them in a better manner? I think in research, the sites just want to give good patients, give good data. So instead of throwing everything at these sites and coming up with all sorts of nuance, why don't we just throw the things that are needed? How do you get the best quality data from a patient with XYZ indication in a phase two setting at the right site? And those sites will tell you, here's what the patient will do, here's what they won't do. Here's what the doctor will do. Here's what the doctor won't do. And you almost have, we have key opinion leaders. You almost need these site operation key opinion leaders. So close. Coming up with new vernacular. But you almost have to have these site operations folks that have been doing it for 20 years or more because they've lived through the tech piece and then the down and then the back up and fully decentralized them back down. We've been doing hybrid studies for 15, 20 years. So it's not new. It's just what's the right piece for this type of technology? So I think some of it is coming up with a better shopping list to go through and find the right pieces to deliver that, right? Like everything is a bit of a mosaic. And the reason why I say a mosaic is that some of those colors, they intersect. And I think in research, we have to look at it as what's the right site combination with the right patient like what patient are looking for what's the right site combination to get that patient then overlay what the pieces are that make them successful and to your earlier comment it's not about what you think is going to make them successful it's about what they think is going to make them successful and it might it might be just a little bit different it might be the same system but instead of having five different things they're doing in it they're only doing one or two and that's going to get you that better data

SPEAKER_00: 40:28

i think i've heard it

SPEAKER_02: 40:29

probably 150

SPEAKER_00: 40:29

times. And I heard it again. It was on the phone research site. It was a study coordinator at a research site. And the way she said it, same thing I've heard before, but I needed to hear it again. And so I'm going to say it out loud and you can tell me if it's bad advice or not. But she said, John, the tech is great. The people are nice. I don't remember what study you're calling about. Could you guys just make sure you all do a better job in context? Know that in your world, you've got these things and you're like, you're doing this. My job is context switching. every four and a half seconds. So I am frantic. I've got a patient in the clinic. I've got the doctor needs to see him. I get on the call and people go, hey, could you check this and check this? And I'm still thinking, is this the star study that I'm working on? That's where I'm at. And so she said, hey, the thing that I wish people would do is not just all the strategy things and listening to us about our opinion on the protocol and the patients and where to get them, which I think are all super fair points because they're the experts. But that reminder just to say, just give me the context. Just make sure you're repeating that because I've got a lot of these going on and I can't remember them all. And I think it's so many times it's the simple stuff, right? It's the simple things that help us to be more thoughtful and empathetic about I'm working with the site. They've got a lot going on. This is what it's like to be at a site, just like all the things you mentioned. And so if I understand that, I'm going to come in this conversation very differently and have a soul about it and say, hey, how can I help you? And so I need to do help you get in, get out, get what you need, but give the context. And for me, that was really impactful. And I said it to my team because I needed to hear it again.

SPEAKER_02: 41:59

Yeah, no, I think it's a fair point. And again, it's the day and age where we're at, where a research coordinator might be working on a handful of studies. A monitor might be working on one. So for that monitor, when they call in, that's the most important question that they're asking. But meanwhile, the person that they're calling just finished a visit on a totally different study, is preparing for a visit on a totally different study than that one. And this person just happened to be at their desk. They picked up the phone. And now to your point, they're just saying, hey, look, I'm calling about this. And they're like, wait a minute, my head's spinning because that's not where I am. Like, that's not where I am right now. So I think it's a good point. I think it's also hard at the site level to be present in that moment. to also be there to listen. And maybe that's where some of the tension comes from too.

SPEAKER_00: 42:44

If I'm a person working in clinical research and I'm interested in working in a site or a site network, right? I'm hearing these terms. I say, hey, I've got good experience or maybe I'm new and I'm trying to get into clinical research. And I believe that learning at a site network might be the best early stage of my career. What do you tell them? What advice do you give them to look at that route? And then second is when they say, great, after all that EB, is AI coming after my job? What do you say to that part of the question?

SPEAKER_02: 43:09

So the The first part, as a side note, I'll tell you that the people that I've worked with at different CROs and different sponsors, the best people have worked at a clinic somewhere in their career, somewhere along the way. I think it's actually a pretty valuable part of your own learning as you're in research. And again, I'm a little bit... Just a little. Just a little. But with that said, if somebody really wanted to get in, I would tell you, look in your area and see what sites are there. You might have to be willing to do some work that you didn't think you're going to have to do. in order to grow into it. Because there are some people that think very highly of themselves and they're in their mid-20s and they've done something and now they want to get into research. They're like, well, wait a minute, I'm at this level and now you're putting me at that level. It's like, well, yeah, but if you want to actually get to this level of research, you got to start somewhere. So if you're going to be in a clinic, you might start as a patient recruiter. You might start as a data management person. You might start as a research assistant, depending on your background. And all I can tell you is, is hang in there. And if you get in If it were me, I would ask whatever group I'm applying to or talking to is like, what is your training program? I don't need to know I'm going to be a next level in three months or six months. It's like, just do you have a plan for me? Or is it just like I just have to gut it out? Because one of the issues that sites do have is once you get to a certain level, there's It's rarefied air at some point, whether it's a regional manager or even a site leader, that might be the best you can do in that particular group until you actually become an executive. And there's not as many of those roles available these days. So my point is, is if you get in and you learn, then you can start seeing these different options and you start seeing what else is out there in research and be a part of it. And then on the AI question, I mean, I hate to be the person who says it's not going to affect sites as much, It's going to affect everybody. I mean, there's ways to be more efficient and effective with your own time. I think it's going to make an effect on sites. When I look at what coordinators do and the things that they do with patients, especially in the harder to treat populations, I think it's going to be hard to replicate that with AI. Mostly, I mean, you used the word empathy before. When you're dealing with late stage cancer patients, you're talking about people that need handholding. They need care. They need to be consoled from time to time. And you can't get that from AI. You can get that from a really good coordinator who's been through it with other patients. And I think that's where research sites separate themselves from paper pushers. Yes, they're delivering data, but it's coming from a human being, not from some chart online. I always say that when you randomize patients into a study, it's a walking lab. I know it doesn't sound great, but it's a human being. It's their biology and their chemistry that's taking over that study. And you have to tether that person into the study. And for us, that tether is the coordinating staff. It's the site. You know, a lot of our patients love to come to the site. They'll still do the remote stuff. They'll still put in their diaries. They'll still have a remote visit if they need to. But they love that interaction because that's where they get empathy that they might not get from tech. No offense,

SPEAKER_00: 46:27

John. Total offense. And it should be. It's the way the world should work. This whole world, in my opinion, right? But it's my podcast, so I get to give all my opinions. Thank God for that, right? You know... this whole world is hybrid and I kind of don't want that to change. I love the intersection of tech and people and we've got to get this stuff right. That's how we move it forward. That's how we're more inclusive. That's how we actually change this market. So no, I appreciate that. I think it's really important.

SPEAKER_02: 46:54

And I tell our team, I mean, I've been trying to figure out ways to utilize AI at the site level and there are ways to do it. I'm not going to share all the secrets on your podcast, but my point to them is it makes you more efficient and effective with your time so that you have that time to spend with your maybe with your peers, but also with the doctor and with the patient, because that you can't replicate.

SPEAKER_00: 47:15

If I'm a research site and I'm maybe not tech savvy, I'm definitely considering just starting with the basics. And the basics are meeting minutes, notes, question and answer. One of the things I saw from a site, and I know somebody got mad at me for posting this, but I said, you could use ChatGPT. You did some research and you want to create an ad for for recruitment locally that was more fitting. It was inclusive of the people in your community and you wanted to go design that ad. You knew exactly what it looked like. You had the template. You could go build it. Things like that I think are super practical, really efficient ways for sites to use these tools, but not going too far yet. Let's just get the baby steps. Start using them. There's so many directions we can go. I want to stop here. Let's just bookend because research sites and networks, now they work, was... Just so much valuable information. So EB, thank you. Thanks for taking time today. If someone wants to connect with you or learn more about what you're up to, what's the best way to reach you?

SPEAKER_02: 48:10

I'm a fan of just giving out my cell phone number. I've been told not to do that in the past, but I just give it out. So you can call me or text me or you can find me on LinkedIn, just EB McClendon.

SPEAKER_00: 48:21

And I'd encourage you, if you're looking for a site network and just an all-around guy that knows the space that you want to connect with, EB is your guy. EB, thanks for your time. Good to see you.

UNKNOWN: 48:30

I appreciate it.