On Research Podcast – Research Site Operations

Adam Roth: We would not be making any headway in oncology, rare disease and cell and gene therapy and all of these things if it wasn’t for our academic centers and medical centers doing this. Because they are uniquely qualified to do that. They’re a huge, crucial part of the clinical trial industry.

Justin Osborne: Welcome back to On Research with CITI Program. I’m your host, Justin Osborne. You just heard a clip from Adam, my guest, this episode. As you know, I get to sit down with a research expert each month to discuss different aspects of the research industry. These discussions will hopefully drive further conversations at your own organization. Recently, I sat down with Adam Roth, the vice President of Research Site Services at CTI. Many of you know CTI is a CRO, but they also run a dedicated research site, which Adam oversees. With over 25 years of experience in the research industry, Adam shared his insights into the research site operations world.

We discussed the different types of research sites, how that may influence recruitment strategies, how DCTs have or will impact physical sites and even discussed the financial impact tech has had on the site side. It’s a great primer really for those interested in learning or growing their knowledge in this aspect of the industry. As a reminder, this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have questions or concerns about the relevant laws and regulations that may be discussed in this podcast. In addition, the views expressed in this podcast are solely those of our guests. So without further ado, I hope you enjoy my chat with Adam. So Adam, thank you so much for joining. Thanks for taking the time.

Adam Roth: Yeah. My pleasure.

Justin Osborne: So tell me how you got into this industry, how you got into research and how you ultimately landed in your current role.

Adam Roth: Yeah, yeah, sure. I think like everybody else, it was sort of happenstance. I think everybody has their meet-cute story for how they got into clinical research because it’s not something we all endeavor to at the age of 12. So for me, I got out of school and weirdly I got a job at a sleep laboratory recording people in their sleep for a clinical setting to diagnose and treat sleep disorders. That’s a good job, except for it was obviously night shifts, which sucked. But the thing that was interesting is that one point they said, “Tonight’s going to be a little different. We need you to be very specific on how you put this patient to bed. We need you to wake them up at this very specific moment, give them this pill and then we need you to record how long it takes them to fall asleep after that and in a very controlled way and all that.”

So they’re giving me very specific direction, but obviously I understood something else was going on here. I also love, weirdly, the rigidity, and I think a lot of people in the industry can relate to that. I think sort of self-select people who enjoy control, systematic approaches and things like that are people who are drawn to this industry. So yeah, I dug more into that and found out, oh, this is clinical trials. Long story short, I ended up parlaying that into a job as a clinical research coordinator in a research site.

Justin Osborne: So then you’re a coordinator for a little while. How long were you a coordinator?

Adam Roth: So I was a coordinator for about five or so years. I was at a place that just did sleep research. It was sort of just starting off, and so I was coordinating and then sort of worked with, it was a company of three, four people. So I was moving through the ranks real quick, Justin, and then we identified, hey, we can take this and do other indications and then we can hire more people and do more studies in other areas. We can open up more facilities and locations to get better catchment areas and different investigators. We also opened up a phase one facility and learned a whole new world about clinical pharmacology. So through that process, I was there for 14 years and was able to get promotions and evolve the business and sort of grow quickly with the business to my final role as director of [inaudible 00:04:12].

Justin Osborne: Okay. So from the beginning you sort of gravitated towards the operational side?

Adam Roth: A hundred percent, absolutely. Yeah. I love the idea of saying, “Okay, we’re doing this. How can we expand this? How can we be more efficient? How can we do more?” That really something I enjoy.

Justin Osborne: That’s great. That’s great. So then after that you moved into sort of a director role of operations. Where’d you go after that?

Adam Roth: So there was just so much about the industry that I didn’t know. And so I ended up getting an opportunity to go into project management at MedPace, which is a large CRO here in Cincinnati where I got to learn obviously project management skills, but I got to learn through the other side of the industry. So there’s a lot of work that happens before a study starts at a site and a lot of work that happens afterwards. So you have to get the study set up, you have to select your sites, you have to build your database, you have to have all your statistical analysis plans, and during the study there’s database management and queries and all of that work monitoring. Then there’s the end of the study getting database locks and all these terms. And so I think that it was an opportunity for me to learn all of that other stuff to have a better broader understanding of our industry.

Justin Osborne: Yeah, no, that’s great. And hopefully, we can dig into some of that. Obviously, we’re talking about research sites and how to run a site here. So that’s a great tease here. So you ran a site. How did you end up in your current role here?

Adam Roth: Well, there was one more stop in the middle. So at that point, I still had a deficiency, I would say, in the regulatory side of my understanding of the industry. So I ended up getting a role at Schulman IRB, which a lot of us know as Advarra as the operations director there. So was able to go somewhere where I could really focus on process improvement and those things that I really love. And then also through that process, though I wasn’t a board member per se. I was learning a lot about the regulatory side, interacting with the board.

Justin Osborne: No, that’s great. And actually that brings up a point, and I know you probably had this conversation with other people too in this industry, that exposure in research is important even if you don’t have the specific role. That’s what I like about this industry is that you can have a role in operations, but because you, like you said, you were at an IRB, you were exposed to the regs every day and having those conversations. It’s nice to be able to have that.

Adam Roth: I agree. I agree. And I guess in this industry you can, if you’d like, you can kind of bury yourself into one area. You can go all in on reg. I don’t care about any of the operations piece. I’m a data management guy. I’m in the data. I love that stuff, but I like more broader understanding and I like to work more multifunction across functions and things like that. So to me, it was really important for me to get that broader understanding. Like you said, even if it’s not my role per se, I love to get that exposure and understanding because I think it just makes me better at what I do.

Justin Osborne: Yeah, that’s good. I feel like there’s some advice buried in there somewhere. So now tell me about your role now.

Adam Roth: So then I’m here at CTI, which is, it’s broadly a clinical research organization, CRO global, sort of mid-tier CRO. But we operationalize and have a clinical pharmacology unit that actually has a later phase program, so a site. And so I was able to move into that world kind of come home to the site world where I think that’s where I really realized through all those sort of experiences, what I really, really enjoy, which is everything that we do in the industry, whether it be in, even if you’re in a sponsor at a company or biotech and you’re working chemically to develop a compound, you’re at a CRO or you’re a sponsor, managing studies in all the ways we talked about for the CRO work, all of those things are to support.

At some point, a patient is identified who you have determined if they qualify, they were given an NIP, and then you’re going to collect data to determine safety and efficacy. That’s ultimately when the rubber hits the road, that’s what happens. And I just realized I really love that working where the rubber hits the road, and this worked out great for me to come back to that, and I was able to grow and develop here into my current role as vice president of research site services.

Justin Osborne: Well, thank you for the background. That’s a really good career trajectory there. So let’s dive into this. We’re going to talk about how to run a research site. I want to pick your brain as an expert in this site world. I guess my first question is can you help me understand the differences between, I would consider you a dedicated research site, so like an independent or a dedicated research site versus an academic or a healthcare site?

Adam Roth: I think there’s a lot of differences. First and foremost is approach. So in a broader philosophical perspective, it’s the approach, a dedicated research site. This is all we do. This is the extent of our business. There’s no clinical practice, there’s no other sources of revenue. This is all we do. And that affects how you run your business if you’re doing other things, and obviously, clinical care and those things should be the priority. Therefore, research is going to be sort of secondary. That’s a big, I think, difference. A lot of the academic centers and hospitals, things that a lot of them are non-profit versus a for-profit organization, like a dedicated research site where you need to focus every day being as efficient and thoughtful in how you run your trials because you’re trying to run a business here.

Justin Osborne: Yeah, no.

Adam Roth: Broadly that’s the big difference.

Justin Osborne: Okay, that makes sense. So then obviously when you have a dedicated business service line, this is all you do, all of your resources are put towards that you don’t have shared resources. That makes sense. In terms of an approach for understanding a research site about study pipeline, how do you think those differ in terms of approaching new studies and that mindset?

Adam Roth: Well, I think that that is driven a lot by another key differentiator, which is access to patients. So at a dedicated research site like ours, we have a database of research volunteers that have a variety of different medical backgrounds, like anybody. It’s sort of just a cross-section of the community. And then we have the ability to do media outreach and outreach to the community. That’s how we recruit and enroll our subjects. Obviously, in a clinical practice or a hospital, the access is much more broad.

You have EMR systems you can go through, the patients are flowing through, so you can catch people and you can therefore look for acute care studies and do different kinds of things. And then obviously the access to be able to do things more in rare diseases and things like that based on the specialties of the different investigators. So I think that, yeah, there’s a big advantage in those settings because the patient access is, to be honest, superior. But if you’re a dedicated center, your focus is what can I recruit from the community? So that obviously is first filter when you’re looking at what kind of studies you can take on.

Justin Osborne: Okay, that makes sense. So then you’re talking about this database that you have and dedicated research sites have to build that over time. I mean, how long does it … I would imagine that that would be one of the bigger hurdles of a new research site, new independent site trying to start. They don’t have a database built. How do you get over that hurdle?

Adam Roth: They do that. So a lot of times they will spin out of a practice, so they may have something they can start off with there. But to your point, it takes time and/or investment. So you really need to invest in it. You have to potentially just reach out to the community and just say broadly, “Hey, we’re here. We’re conducting trials. If you’d like to be in our database, we’d love to hear from you.” And then we’re just going to broadly say, “Okay, let’s find out what medications you’re taking, what’s your medical history, all of those things so we can build a database that we can in the future query based on inclusion, exclusion criteria and call you about a specific study.” So yeah, it is hard to build. Our database is about 40,000 individuals and it’s taken 25 years to get there. It is the number one sort of asset, I guess you would say that we have.

Justin Osborne: That makes sense. Okay. So now I’m thinking about just these two, right? I’m sure there’s a lot of differences between the site worlds, just using these two examples that we’ve talked through in terms of resources and then patient access, it seems like it’s a balance. Is it common for independent or dedicated research sites to partner with the healthcare academic sites on a study? It seems like there’s some synergy there.

Adam Roth: I couldn’t agree more. When you discuss it here on a podcast and things like that, the synergies are evident. You have amazing access at these centers to access to patient population, these things, the dedicated research centers have the infrastructure and processes and sometimes, to be honest, even access to the opportunities that they could bring together and work. As many know, the devil’s in the details on that. Obviously the patients, rightly so, or they’re very much, they want to protect their patients in a clinical practice and they want to make sure that they’re managing that as efficiently and completely as they can, and it’s just large academic centers and things like that. There’s layers of decision makers and legal and all those things that make that a lot harder to do. It does happen for sure, but it isn’t easy. That’s for sure.

Justin Osborne: Yeah, yeah. No, it’s always in the details. So you had kind of mentioned this about how you take on new studies and whatnot, but I’m curious, can you kind walk us through or help me understand how you evaluate whether or not you take on a new study?

Adam Roth: Yeah, absolutely. So this step is crucial really for and especially an independent research site because you want to make sure that it’s something you can do and do well because a business, but also you’re only as good as the last study you ran, especially within a particular row or sponsor. So you want to make sure that you don’t take on studies that you can’t execute well. Really what that comes down to is really conducting what we call internal feasibility. So in the industry, feasibility typically means at a project level determining what are the appropriate sites for a study, what’s the broad sort of enrollment trajectory, and how will this study be executed. At a site, you’re sort of looking inward and you’re saying, “First and foremost, do we have access to this patient population? Review that criteria. Can we enroll these people?

Secondly, is this something they’d be interested in? What’s the IP? What would be the patient experience? Is this something that would be of interest to patients? And then what else do you have going on? Competing priorities and making sure you have the resources, and then of course, can you pull it off? Can you execute it?” So you got to look through the protocol to understand what are the procedures required, what’s needed to do to execute these things. So I think if the answers to all those things are yes, then I think it’s something that we then proceed with. But it’s important that you, and I think appreciate it in the industry when a site says, “You know what? We’re probably not the right site for you for this, and here’s why.” That’s good feedback for them, and they can move on to a site that may be a better fit.

Justin Osborne: So to that point, I’ve heard other people in the industry talk about this from a site level, that sometimes people feel at the site level that if they say no to a certain study that that’s going to somehow look negative or there’ll be repercussions. Give me your sense on that.

Adam Roth: Yeah, I feel that sense all the time. You feel like you may never hear from these people again, and you want to work with that organization. It really does come down to, I think that you’re not taking that study. There’s that risk that you mentioned. Taking the study and failing, I think is a bigger risk. So we kind of take that perspective and approach, and really it comes down to having that conversation and really explaining to them, “Hey, we want to do this study, but here’s what we can do.” Sometimes they’ll say, “You know what? We’ll take your best shot. We’ll take your best effort. We really want you in the study.” And we’re open to that. But we want to be open with expectations and not say, “Oh yeah, we’re going to blow it out of the water,” when we don’t think we necessarily will. So yeah, that is a tug of war that I deal with a lot, Justin. So I agree that is a concern, but it’s something I think you manage by good sort of communication with your sponsor and CRO partners.

Justin Osborne: That makes sense. So going back to the feasibility aspect, and so I’m thinking from the sponsor side, they send the site, the feasibility survey. Is that the same survey that everyone loves? Is it the same survey that a dedicated research site would fill out as opposed to a more academic healthcare site? Or is it all the same to the sponsor?

Adam Roth: From my experience, it is. Yeah. I mean, they’re going to look at things because you’re going to get at all the things that are going to be different at those places. They’re going to ask about patient access, of course, and enrollment projections, but they’re going to ask about how is your startup efficiency? What’s your regulatory processes? Can you use a commercial central IRB? Do you have 10 different departments that need to chime in on this? Can you do regulatory submissions while you’re doing budget negotiations and contract negotiations? All these questions they do ask. They think they’ve hit upon the pros cons of these different groups. So I think it is pretty much the same kind of process.

Justin Osborne: So then on your side, are you saying that at your dedicated site level, when you’re talking about evaluating whether or not you take on a new study that you’re filling out that feasibility, but before you even, or I guess while you’re doing that, you’re looking internally and doing a similar type of assessment to say, “Do we have all this? Is this okay?” So that’s in addition to just simply filling out that survey?

Adam Roth: Absolutely. Absolutely. Yeah, we need to do that first, especially if you’re looking to expand into an area that maybe you don’t have so much experience in or you’ve never worked in. So then you’re reaching out to your clinicians and folks and say, “Take a look at this thing.” You’re reaching out to your recruitment individuals and saying, “Can you query the database? Take a look. What do we got? How can we do this?” Yeah, and depending on the things you may be asking your pharmacy, “Can we compound this drug the way they want it?” Those things. So yeah, you need to do all that work, I think, before you jump into the feasibility questionnaire.

Justin Osborne: So let’s jump to recruitment because that’s always talked about as the biggest hurdle in research. Walk me through some of your strategies at a dedicated research site of how you manage recruitment.

Adam Roth: I always sort of say because we’re not a clinical practice and the patients aren’t … they don’t come here unless they’re here for a study. So whereas an academic center or hospital clinical practice, there are people walking through the door every day for clinical care. So you have those opportunities to interact with people. Here, we have to enroll by what I call brute force. So we start off, we’ll do a query of the database, as I mentioned. Based on the criteria, we’ll then have an outreach approach. So based on the query, let’s just say there’s a couple thousand people, we’re going to try to blast that out, the message of the study out to those individuals. We’re going to get on the phone, we’re going to start calling them. We’re going to go through an IRB approved script, and we’re going to sort of determine does this person look like they have a good chance of qualifying, and then try to get them scheduled in to come in for a screening visit after we’ve informed them about the study, and again, confirm they’re at pre-screening eligibility, right?

It’s not really an eligibility. Nobody’s getting any medication based on this work here. It’s really just is it worth our time as well as very importantly, the potential subjects’ time to come in for a screening visit, and then we’ll try to drive inbound interest. We can call people all day, but it’s the number one criteria of being in a trial, I always say, is the subject interested? Because they could qualify all day long, and if they don’t want to do it, it doesn’t really count. When you do outreach to the community and they call you, they meet that crucial, are they interested criteria? So that’s a really nice step we have. We are much more likely to end up having that person participate when they call us. So we’ll leverage our social media platforms, our website, and all those things that we have standards. And then based on the budget of the study, we’ll do some paid marketing to the community as well.

Justin Osborne: Okay. So the interested piece that you talked about as being crucial, do you have a process for either in your database or as you comb through your potentials, do you have an opt in opt out process?

Adam Roth: Yes, absolutely.

Justin Osborne: How do you operationalize that?

Adam Roth: Yeah, so in our database, we want to keep all the legacy data and things like that, but we can inactivate them, which basically makes them invisible to any of these queries that I referenced. So if we’ve gone a long period of time, we can’t get a hold of somebody, we’ll sort of just inactivate them ourselves because you don’t want a lot of, to get a false sense of security when you’re doing those feasibilities. So you really want people, if they’re not interested, you don’t want them in your database. If they’re changed their phone number, we can’t reach them anymore or whatever, we don’t want them in our database because it gives us a false sense of feasibility. And we let them know, “Hey, if you don’t want to get these calls, if you don’t want to be involved, that’s okay. We just have a process where we will inactivate you. You won’t receive any messages. You won’t receive anything moving forward.”

Justin Osborne: That’s good. That’s good. And that makes complete sense because again, and this is the problem, I know that exists in the healthcare side, academic research site side, that even though they have the patients in their EMR, the interested, to your point, the interested aspect of that is never comes through that system. Right?

Adam Roth: That’s right.

Justin Osborne: Figuring out how to get through those weeds is difficult on that side because then you look at a feasibility and coordinators are just going into their EMR and saying, “Oh man, we have thousands of patients with this. So no problem to enroll.” But again, it sounds like it goes back to resources. They don’t have a call center. They don’t have people who are checking regularly on this.

Adam Roth: That’s right. That’s right. So they’re going to try to catch as they can try to hit the day of their EMR and reach out to people and some opportunities. But yeah, you bring up a great point is that, and I’m not going to quote it, because I don’t know the numbers off the top of my head, but I know that there’s been some published data on it’s a ridiculously small portion of the population who actually want to participate in clinical trials. If we need to improve that, they can grow that, then that’s a whole nother podcast with somebody a lot smarter than me. But when you have an EMR, those people don’t necessarily have an interest, and we know statistically they probably don’t. So that is got to be a tough thing in those kinds of sites to really get that good sense of feasibility, whereas people in our databases to be the participant in the study or voice in interest in participating in the study. So that big filter right off the bat that needs to occur has sort of already occurred in our database.

Justin Osborne: So not to put the dedicated research site bucket on the hot seat necessarily, but it seems like everything you’re saying here in terms of how you guys have the resources, you are in the community, that’s your first pass at getting people into research. Thinking about the fact that what you just talked about, the educational aspect of research, most people either aren’t interested. You can probably draw that back to the fact that most people don’t actually know what we do in this industry. How does a dedicated research site take on the responsibility of educating the community at large about research?

Adam Roth: Yeah, that’s a great question. I don’t think it falls on just the dedicated research sites. I think it’s all of us in the industry. How do we inform people then? I think that there’s just so many success stories. It’s like anything else marketing, right? Gosh, no, I’m not going to take some investigational medication and they’re just going to poke and prod me and do all this stuff, and it’s just for money and these things. I think that letting people get a feel for or even meet some of the people who participate in studies here or at all the different kinds of sites, they would see in a lot of cases, the experience is quite different, that there’s quite a rewarding element to it. They do get to get some benefits to their healthcare, and in some cases, significant ones, they get to be part of this endeavor.

We always tell people, when you open your medicine cabinet at night and you need to give something to your kid who’s not feeling well, it’s nice to know that there’s been an evaluation of that medication and that you know as good as you can, we’re never perfect, that this is safe and it will do what it’s supposed to do. That’s something we sort take for granted, and I think that that message is something we need to do. Do we do that on a routine basis? No, but I think it’s something more at an industry level that needs to occur.

Justin Osborne: Oh, I agree. I agree. We’ve kind of touched on, or you mentioned budgets earlier, so let’s shift into the financial side of the research site. Walk us through and kind of explain how you manage the financials of a research site. I feel like this part of the research industry, if you’re not on the operations side and you have kind of stayed more to the compliance and regulatory side, this is a blind spot for sure. I don’t think that side of research understands how finances work on your side.

Adam Roth: Yeah, I completely agree, and I think that this definitely will feel soapbox point in this discussion, but there is just a disconnect in how sites are compensated versus CROs, for example, in our industry where the idea of a CRO doing anything for a trial and not to be compensated for it, it’s just it’s unheard of. And it’s a lot of, at the site level, the contracts are usually constructed speaking very broadly, of here’s what your compensation will be for enrolling a subject. Compensation for all the procedures, all the things need to be done in that protocol, in the schedule of assessments, and then, yeah, here’s some startup money.

Not going to probably cover your startup activity, but here’s some startup. So that’s sort of how it is. Really, there is just so many hidden costs beyond that that are just sort of not covered. And as I mentioned, it’s sort of based on how many multipliers of how many you can enroll in a study that if you don’t get that opportunity to enroll, even if it’s something outside the control of the site, so the study doesn’t move forward, that ends quickly, the sites don’t get up and running right away, supply issues, things that just happen. There’s really, you lose that ability to recoup that investment, because it’s a lot of work to get a study up and running at a site, and it’s not typically something that is fully compensated.

Justin Osborne: So help me understand the startup then because it sounds like that’s where maybe some of the lost revenue is, the hidden costs. What are the pieces? So I’m thinking there’s a contract, of course, there’s a budget. What else?

Adam Roth: Right. So there’s obviously a lot of regulatory work that needs to occur. You need to be prepared for when those patients start rolling in. So you need to have a plan for recruitment. You need to have all of your source documents developed to make sure you’re collecting all the data you need to collect. And then there’s a myriad of training that needs to occur for the good reasons. We have to have training and documentation of training for everybody on the study of the procedures and components of the studies that are going to be delegated. That all needs to be done. There’s sort of a newer thing in our industry, not this year newer, but over the last many years, much more complexity in terms of systems, eco, ePRO elements that require additional training, engagement in myriad of systems and all those activities. There’s also the monitoring that CROs and sponsors need to do, but we have to support that activity. We have to respond to them and be responsive to their needs, and those are those hidden costs, I think, that are missed a lot in these contracts.

Justin Osborne: So then talking about the different electronic systems, I thought, and I think the assumption was that the quicker you can get on an E-system of some kind, the more efficient work will be. It sounds like maybe that’s true on the sponsor level. Maybe that doesn’t hit the site the same way. Walk me through why that’s more of a burden it sounds like, and becomes a hidden cost for you all.

Adam Roth: Yes. I think it’s a couple reasons. One is because it’s so disjointed, so there is, its capitalism. So there’s just a limited number of organizations who have developed these softwares and these systems as well as proprietary things that are developed by sponsors and CROs. So you’re working across a lot of different systems. When you’re taking on multiple studies. We have 25 to 30 studies ongoing at a time, so that could be 10 to 15 different systems. So you have to understand and learn all those different systems. It’s also based on an assumption that they always work and they always talk to each other and they don’t. So we end up being default tech support for our patients because on the ECO and ePro we use, the patients know us, they have our phone number. They don’t call the sponsors or CROs. So we end up being that piece.

So I think those are why there’s some efficiency issues there. If the industry all agreed on one system for everything, which will never happen, it would be great. The other piece is that we also have to exist and work agnostically to our studies and our sponsors. So we have develop our own solutions. So we have a CTMS, we have different systems, we have an electronic investigator site file, sites can have electronic source and other things. So you’re developing beliefs, you’re developing your processes to support those things, and then they say, “Okay, on this study, use this different system.” And so now you’re kind of working outside of your norm, outside of what your standard is, and you have to sort of modify your processes to work with their systems, which is just wildly inefficient.

Justin Osborne: Yeah, I mean, you as an operations person, a big part of business operations is scalability and figuring out efficiencies. How do you do that in an industry where next year, there could be a dozen more systems that you have to all of a sudden pick up and learn and build around?

Adam Roth: Absolutely.

Justin Osborne: So back to the financials, it seems like things like that, can you not just put a budget line item into the sponsor, or is there some sort of industry expectation or norm here that goes against that? How is this more complicated than it sounds? You know what I mean?

Adam Roth: Yeah, totally. The answer is yes. We can try to put a line item in those things for those fees and it’s additional costs and so that it’s different from what it was. They’re selling these things as efficiencies to the sponsors or CROs to the sponsors, and when there’s additional costs on side level because of it, it’s a tough sell for them. But I think yes, the answer is we can. Is the industry getting a little bit more acceptable or understanding of that? A little bit, but a long way ago, a lot of times it’s just, “Nope, we didn’t budget for that. We don’t have a plan for that.” And we have to ask ourselves, “Okay, do we want to study or not? Do we make this work?” And that’s what we ultimately have to.

Justin Osborne: Okay. So how much does the financial aspect and the budget of a study go into the consideration of whether or not you take this study? Is it simply a numbers game? Where does that fall in the hierarchy?

Adam Roth: Yeah. Dedicated research site or site organizations and networks, I think it’s obviously crucial, right? It’s at the top of the list. Even if the study’s interesting and could be impactful, it needs to be something that you can execute and be successful in on a financial aspect. And maybe obviously that’s an advantage, and there is a lot of advantage, by the way, to academic centers and clinical practices conducting trials. And one is they may have a little more flexibility in that space and be more focused on how does this benefit our patients? And so that, I think they have an advantage in that respect because again, it’s a small portion of really the business element of healthcare.

Justin Osborne: I mean, at the end of the day though, no money, no mission, but that does make sense back to the differences. So I do want to ask you things that are going on in the industry right now that could affect you or impact you. I’m curious how DCTs or Decentralized Clinical Trials have impacted your world at the dedicated site.

Adam Roth: Well, I think that they started impacting our world long before we knew what Decentralized Clinical Trials or DCT acronym was being bandied around in that there are always, not always, but for a very long time now, there have been elements of studies that have been sort of decentralized because of technology with the use of telemedicine, home care nursing, eco, ePro, you can get a lot more information from a patient. You can engage with the patients outside of the clinic more. So there’s always been elements of that, not always, again, but for quite some time now. So we’ve sort of absorbed that over time and it definitely helps, I think, everybody, but the full sort of panacea of this is this idea of a fully decentralized trial, that obviously would have significant impacts to a clinical research site, but A, we’re not seeing a lot of that yet.

And B, I don’t know if it meets all the needs that we think it meets. A lot of it is designed with the idea theoretically. It’s not about cost savings, it’s more about getting opportunity to enroll more patients and get access to studies to more patients and in certain indications, certain areas, certain rural communities and those things, that is true. But there’s also an element of being involved in clinical trial is from a patient’s perspective is something that I think having confidence, reassurance. I think it’s just a human nature element to this. When you’re going to be taking an investigational medication, it’s nice to meet the people face-to-face.

There’s still a human element to this, and maybe this is a generational thing and this will change, but that you know this organization is equipped to really take care of me and that there’s some legitimacy, I guess is the term I’m looking for, that comes with the brick and mortar that would be a challenge to recreate in a fully decentralized environment. If I didn’t meet somebody and I did a video call with somebody and that ended up with an investigational product that showed up in my mailbox, I’d be nervous about taking that, maybe more so than I would if I had gone to a clinic, met with the individuals, saw the doctor, talked to them, had my questions answered, pharmacist comes in, goes over things with me, that’s different. So decentralized clinical trials in a lot of cases have a lot of benefits. I think the technology has a long way to go still, but it’s definitely impactful to our sites and to our patients.

Justin Osborne: That makes perfect sense. I mean, I struggle building Ikea furniture, so if I get a product that shows up with instructions on what to do with it, that’s kind of a scary thought. Well, Adam, this has been great. I really appreciate you taking the time to talk and kind of explain the research site world.

Adam Roth: Absolutely. It’s been my pleasure for sure.

Justin Osborne: Welcome to a new segment we’re doing. I’m calling this SANE team. So I thought it’d be interesting to have a sort of mission moment with our guests, ask them to reflect on their own careers and learn a little bit more about them in the process. So I have Adam still with me here. Adam, this has been a great conversation already. We just talked a lot of inside baseball about research sites and how to run a site.

We all know it’s easy to get bogged down in our particular job focus, whether it’s finances or operations, regulations, whatever it is. But I do believe that most of us that do stay in this industry, stay in research because of the potential impact that it has on the healthcare of ourselves and our loved ones and you mentioned that. On some level, I think we’re all thinking about the research participants and how our work can make a difference. So thinking back through your career, can you tell me a personal experience of yours that kind of connects you with this idea that we’re all in this industry to help?

Adam Roth: Yeah, absolutely. And I think it’s a great question because we all get in anything, like in any endeavor, I think we get sort of caught up in the day-to-day. What do we have to do today? It’s a business. You and I used the term business a lot. We talked a lot about that stuff, but we ultimately do this to make a difference from the healthcare perspective globally. And nothing brought that more sort of into focus recently. It’s hard to ignore was the COVID pandemic. So we got the opportunity to participate in a COVID vaccine trial very early in the pandemic when it was clear, it seemed at the time that a COVID vaccine was sort of our best path to getting our lives back and saving so many lives that we were seeing every day on TV that were being lost at that time. So I have to admit, there was kind of a cool factor to it to be involved in something so front and center.

I always joke that when we work in the clinical research arena, we don’t have the coolest job at parties and things when people ask what do you do. And finally, during that time, we did have the cool job. People on the news were hearing about the development of these vaccines. They were learning terms like phase one, phase two, phase three, and safety and efficacy and all these things. So we had the cool job, but the bitter irony was that it was during a period of time where there were no parties or get together. So I couldn’t really brag on my experiences there, but it was just so in your face, what you were doing was having an impact that you could see on the news every day. So we were seeing people engaging in clinical trials that never would’ve engaged. We were seeing the altruistic element of participation was front and center.

People were saying, “Look, I feel powerless because of what’s going on here and I can’t help. I can’t fix this, but I can do this. I can participate.” And then even with us as a team, these were massive studies. You had to kind of bring everybody together in a very team environment and really execute these studies quickly and efficiently and with the highest degree of quality in human subject protection that you could. And it really brought our team together and really focused us on the end, not the means as much. So to me that was sort of that moment in my career where it all kind of came together and the why was clear every day.

Justin Osborne: No, that’s great. That’s great, Adam. And I agree. I feel like because that wasn’t that long ago even, right? It feels like forever ago and so many aspects of our life were trying to move past it for good reason. But the momentum and the focus behind research at that time, you’re right, was exciting for all of us in this industry. I think some of that momentum has continued. I want it to continue more obviously. I wish that that sort of focus on it did maintain.

Adam Roth: Couldn’t agree more. I think that that was the other piece is the level of sort of community in the industry at that time was fantastic. And the sponsors and the CROs and the IRBs and everybody was sort, “Hey, how can we help you? What can we do to help you get this done? How can we make this work?” And everybody wasn’t so much focused on the bottom line and what they can build for. And it was really a time where it was about we have a job to do and we need to get this done, and how can we all think about things and not just say, “Well, if our SOP says this and our process says this and our standard is this.”

Everybody said, “Look, we have the framework of we’re not going to sacrifice human subject protection, data integrity, safety, all these things. We’re not going to do that. But with that in mind, how can we be thoughtful and flexible about how we’re doing things to make this happen?” And that is something that was really, to your point, would be great to see if that can move past or continue to be part of what we do. But it was a good moment in time, for sure.

Justin Osborne: Well, again, Adam, thank you. This has been fantastic. I appreciate your insights and you sharing so much with us.

Adam Roth: Yeah, absolutely. My pleasure. Thanks for having me, Justin.

Justin Osborne: Be sure to follow, like and subscribe to On Research with CITI Program. If you enjoyed this episode, you may be interested in other podcasts in the CITI Program universe, including On Campus and On Tech Ethics. You can listen to all our podcasts on Apple Podcasts, Spotify, and other streaming services. In the show notes, we’ve added a couple helpful links from this conversation. One link is to the CTI participant database. So if you’re interested in signing up for future research studies or you just want to see what a participant database looks like, check it out. You should also review our content offerings regularly as we are continually adding new courses, subscriptions, and webinars. Thanks for listening.