Episode 24: John Reites, THREAD

John Reites is an executive intrapreneur turned digital health entrepreneur whose career includes over 18 years leading global drug development, clinical research and decentralized trials for life science organizations. As CEO of THREAD, he is leading efforts to change the way clinical research is conducted, focused on decentralized approaches.

 In this episode we discuss John’s experience as a clinical trial participant, lessons learned from Disney World and the current state of decentralized clinical trials.

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+Full Episode Transcript

Brad: All right. Uh, today on the show we have John Reites. John, thanks so much for coming on today, man.

John: Brad, thanks for having me. I really appreciate it. Looking forward the conversation today.

Brad: Yeah. I know we've had a lot of back and forth getting this thing scheduled as we know that clinical research is a crazy right now as if you know everything else in the world. Isn't crazy. Uh, so thanks for bearing with me and being patient, and I'm glad to finally get you on as always, you know, with everybody I'll bring on. I kinda like to start out with, uh, just tell me a little bit about, you know, your background and kind of what brought you into clinical research. I think it's always, uh, always kind of enlightening to me to see the different, different paths people take to, to get into clinical trials.

John: Sure. Yeah, no. Um, I am probably the, one of the least likely people to get in clinical research. Uh, the only C I had in college was in biology. So I would actually say, I think most of my teachers would think this wasn't the direction I'd go. I think, you know, like most people, you know, we, we have an idea of what we want to do as a career. And for me, a series of sort of events happened where I was going to be working at a job in communications and that failed. Um, and I got an interview at a CRO, uh, and it was more, the person said, it'd be more like a practice interview for you. You won't get the job. And unfortunately for them, I got the job later that day. And I started working CRO as a clinical assistant, which basically back then meant I answered phones from sites and I moved around paper files. So that was my job. I was like chief paper pusher. And so openly, I didn't, I didn't come into life sciences or to clinical research by saying, this is what I want to do with my life. It sort of fell into it through a series of really interesting sort of steps that I'll I'll, you know, say for time today. But, uh, but after getting in, what was really intriguing to me is, is I came in without sort of that scientific background. I learned everything about a 1572 form at a dinner conversation in 20 minutes. So I really wasn't educated from that perspective, but what I really did like is, is understanding the, what we did and the, what we did was we were, you know, helping to develop medicines and medical devices that me and my kids and my kids' kids would have the opportunity to use right? To improve their life. And so for me, the mission and sort of the benefit of doing clinical trials kind of hit me really hard really early on. And so, yeah, I kind of fell into it a little bit, you know, it, wasn't sort of this structured mindset of thinking to sort of plan how to get into it. But once I got in, I kind of got bit by it and really intrigued by it. And then, you know, just to kind of end this question, I, you know, for me, it was once I started doing the work, like helping sites, being a CRA, being a data manager, being a project manager, and I got to see all these different aspects. I started looking at things differently as to why are we doing it this way? Can it be done better? Shouldn't we be using technology for X, Y, and Z. And so then I kind of got sent to the principal's office a lot. Right. For basically, you know, trying to come up with new ways to do things or challenging those current systems. And so, you know, for me, that's how I got into it. I would not have planned it, but, you know, looking back now, you know, 20 years into the past, I'm, I'm glad it happened that way. I wouldn't want it any other way at this point.

Brad: Yeah. I mean, I think that's, what's been fascinating to me and talking to all these people is that almost no one sets out to be in clinical research. It's just not, it's not something most people, you know, necessarily aspire to, but it just, like you said, once you get in and kind of get, get bit by the bug, so to speak, there's just a, there's so much room. I mean, aside from the obvious altruism of clinical trials, I mean, there's just about anything you're interested in is kind of contained within clinical research to some degree. So yeah, that's what I continue to be fascinated by. So I guess, uh, you talked about, you know, your struggle with seeing like technology not being used and implemented maybe appropriately or as best as it can. So, uh, where does that sort of bring you to where you are today?

John: Yeah. Well, what happened was, is, and I'll kind of give you a few moments in time. I got a chance to be a clinical trial participant. Uh, so I got a chance to be in a clinical trial. Like I dunno, maybe like eight years into my career. And I was re I mean, Brad, I was excited to be a part of a clinical trial, right. This is the thing that we all do (right?). And I remember they gave me my informed consent form and I was like, redlining it and like, oh, you missed a spot here. And this is in the wrong section. And you missed the initial gap on the lower right hand corner. Like this was me because I was just really enthusiastic about being involved. Um, and then fast forward three months I dropped out of the clinical trial and I was actually one of the worst experiences I had. Um, and I will tell you that openly, I remember having conversations early on after leaving that study to the effect of, oh my gosh. Like, I can't believe that this is like, this is how it actually works. Um, and so the way I articulate it is I feel like somebody who managed a store, but never shopped in it. And when I shopped in it, I kind of went this isn't at all, what I thought I had been running in building. And so that happened. And then a few months later, I got this chance to, to go to a place called Walt Disney world where like 25% of all my income goes with three kids. And, and I got a chance to, to test out this thing called a magic band in this Disney experience app and some other components. And the intent was to take something that was, you know, very stressful. And if you haven't been to Disney world or taken a big family there, trust me, it's not the equivalent of anything as life changing as clinical trials or healthcare, but the stress level of going on these vacations is, is amazingly high because they're complex and there's a lot of complication to it. And it took something that's really complicated and tried to make it very simple, very user-friendly and use a combination of omni-channel experiences, meaning a phone app, a web experience, an onsite location, right? The parks and your ability to do all these things much more, simply much more planned. And so remember, I'm coming out of this experience where I'm kind of a little bit disenchanted with, oh my gosh, like I got to change research because my experience personally, wasn't what I thought would be. And then I had this happen, right where I said, oh wow, there's something here that where technology could help. `And then the third thing is at that point in my career, I was doing a lot of work in some innovative ways to do trials with the first apps and wearables and digital recruitment where I was actually gathering patient insights. So we were going to participants in advocacy groups and polling people that would particularly recruit and pay and studies. And they were telling us, these are the gaps. These are the things that would help us participate if it were easier. And so for me, it was kind of the combination of those three things that really motivated me and sort of changed my perspective on the fact that technology could be an enabler that could possibly move our industry forward if it's done right. If it's done with the right stakeholder views. And if it's done, when we think about our personal experience, when we think about what actually works in the consumer world, and when we think about what actual patients and sites see as being helpful to them. And so that sort of three product combination is really where this kind of mission or vision for what I wanted to do in clinical research. Really.

Brad: Yeah. I know that's an interesting point. I think, you know, even going back to your, your participation, I think, you know, a lot of clinical trials have a sort of, uh, you know, for lack of a better phrase, it's almost a customer service problem. You know, we're making it extremely hard for people to participate in these trials and, and we're not giving them, you know, the experience that, you know, they deserve to have in order to retain patients in trial. So, uh, you know, we use technology now even, and I mean, look, we're handing out E-diaries, you know, the Samsung phones that are 10 years old that are on their last leg or don't function properly. And we ended up creating more problems sometimes for these patients than we would've, you know, otherwise by maybe having to bring them into a clinic to fill out paperwork. I mean, is that a, is that sort of something you guys address, uh, throughout your current company?

John: Yeah. I'm sorry. You should not be using ten-year-old Android devices. There's a lot in there that you're right. Is his history of it, of the industry. That's not accelerated fast enough. And so maybe, maybe what I would say is there's a couple of perspectives here. You know, one is when we look at technology, technology is the thing that's supposed to be seamless. That just makes things work in the background. It's not supposed to be the show. And when you think about the use of technology, you have to remember, why are we putting in, in studies? Like, why are we trying to use technology? Why are we trying to decentralize these studies? We're trying to make them like, use, like you note at the beginning, we're trying to make these easier for participants to participate and frankly, make it easier for sites to spend less time on studies, right? With multiple technologies and some old, some new, you know, sites have, so have such a huge volume of technologies. They use that when, you know, like are a, part of our mission is to bring all this together in one. So when we have sites come back and go, oh my gosh, I, I did consenting and eCOA. I did a telehealth virtual visit and I filled out my, my CRFs all in one place. Then it only took me, you know, uh, 30 minutes, not three hours, which is my typical, that's the kind of feedback we're looking for. Right? That's the kind of experience that we're trying to change and trials. And I think you're right in the Brad. When you think about the use of technology, you know, one things we learned and it really started early on back in 2015, we helped watch for the first eight apple research kit studies. And these were BYOD, meaning we put a study apps on people's own phones. We didn't actually provision them a phone. And that, which was very, very, I had been doing that before, but that was still really new back then, um, in this model of, of starting to shift the work so that the technology would actively and passively collect data from patients during studies to reduce the amount of burden that they had in contributing, but also make it so they could contribute data, whether it was less, you know, issues of recall, right. They didn't have to wait and make a diary of something for three months and then bring it to the site. And the site had to translate it and talk through it. So a lot of those things, you know, technology was able to repair, but at the same time, you know, it does start with, you know, some of the real basics, right, which is, you know, 365, 24/7 tech support, right? You've got to be available for people to call and get help when they need it. You have to have a phone and, and these apps can not look like Snapchat. They had to be very simple user experience, very simple user interface. So a lot of these core constructs of what actually makes technology work and what makes consumers of all ages and demographics and backgrounds and Android and iOS users to use common apps is a lot of commonality. We see in the consumer world, that thread just brought into the clinical trial world to really help the user experience to be quicker. And that does start with also to, uh, provisioning more modern phones. Cause most people, even when you go across the globe, I think a lot of people have an expectation that phones are not very, um, new or current. And that's absolutely incorrect. You'd be shocked at the amount of phones that people have. But then if someone can't afford it, doesn't have a phone. You then provision a device when you provision it, you don't give him a ten-year-old Android on his last leg. Right. You give them a little device that can stand the test of time. It'd be in the study for years to come.

Brad: Sure. And let me ask you this. Why, I mean, why has it taken this long for clinical trials to start to get to this point? I mean, we're, we can move millions of dollars in an app on my phone with no problem. So, I mean, what do you think has been the issue and really getting technology better integrated with clinical trials when seemingly there's already solutions for almost every everything else out there? Like what what's, what's the holdup? Why?

John: Yeah, I think there's two, two kind of sides of this coin. One is what's unique about our industry is we're putting experimental medications and devices in people's bodies, right. We're not helping them move money around. And so that does take a level of regulatory scrutiny, a level of measured scalability, right? All of these things that have been in our industry for a long time are there for a reason. It doesn't mean that we couldn't be faster as an industry. And if you look at like COVID-19 is a good example and what the whole industry shifted to do to support studies that were struggling, that couldn't conduct visits, like where we were putting in virtual visit models across the globe in Europe and Asia PAC in north America, because we had to write so out of necessity, the industry was able to shift to move really fast, especially in the development of COVID-19 vaccines. Right. We saw that shift and how, how that worked out and how that became a life-saving moment in our history. But the reality is, is that, um, is that it's really hard to do things in our industry quickly because again, you know, of the nature of the business and the work we're. And so what I would tell you is what counteracts that is, you know, when you think about being a technology company and understanding tech, understanding technology in, in clinical trials is only one piece of a bigger puzzle you need to have to be successful. And what I mean by that is, is that a majority of like my other co-founder other, a lot of people in our company across the globe came from sites. Like my head of product ran was at a site network for a long time and was a coordinator and was a site, right? A number of our team members are from sites from, they worked in CROs. They worked in pharma. So people that understood the process and how to mature it and make it more innovative, make it more modern, bring it to life. You need to have the technology prowess, you have to be able to have that clinical trial understanding. And you need to have this ability to not think sort of about a research stakeholder, like a site, like a home health nurse, like a patient, you have to be able to think like them and, and, and get in that model. And I think that's the one thing that makes technology work really well in the consumer world that I think we've been slower to do or slower to adopt in our industry. Um, what would I would say though, is, is I know it may sometimes feel like things are not moving, but I would tell you things actually are moving and are moving at a pretty accelerated pace. When you think about decentralized trials as a model, um, I often joke when someone says, oh, this new thing it's really cool, or I really want to hear more about this new thing. I joke that it, I kind of feel like a band that's been touring for 10 years and then just got signed. And so people are just now listening to the record and, and, and, and for those who don't know records of these things, we used to give out to people they would buy and put them in there. You know, anyways, I, I feel like, you know, this has been around for a long time. I mean, I remember being the first of these in 2010, 2011 to 2012 and building tech and write protocols and publishing, and it's just taken this long for us to see these movements really mature. But what I do think our industry does a good job of is when we get to something that can be put into maturity, it scales well. Um, and we've got a good track record of that for, for things like ETMF and EDC and IRT. And RTSM like, you look at our industry and how we've been able to adopt those very similar path. Once it got to critical maturity, it really moved forward and became a standard eCOA. Right. Look at all these different things that we've seen move. So, Brad, maybe that's kind of the balance here is the why, but also that there is a lot of movement here and it's significant. It's not a small amount of movement in our industry today.

Brad: Sure. No, that's fair. I think, you know, I operate a site network. I I've obviously have a perspective that's, you know, at a, at a site level. So, you know, having, seeing things like, uh, you know, I've got 50, I've got 50 logins to different systems, you know, I've got E-Pro devices across, you know, four different companies, just, you know, it, yes. It seems like there's a lot of movement, but you know, at this point there's just so little standardization across that, which makes everybody's lives very difficult. You know, obviously I think that that will probably consolidate as, as time moves forward, but, you know, I think it is harder to see how quickly things move from when you're sort of at the site level. Uh, and obviously dealing with some limited number of sponsors and studies. So it's just, it's interesting to me to see the way things are going and then sort of, as it slowly trickles its way down to the site level where, you know, which can be, I mean, it can be frustrating to be, to be perfectly Frank watching, watching from the site level and saying, you know, you've got, you know, the pharma companies. I mean, it seems like it would be in their best interests to get these things accelerated and moving at a, at a much faster pace. And again, that's not to talk down to the speed at which things move, but it's just been, it's a curious observation from a, uh, from a site level, I guess, so to speak.

John: Yeah. And, you know, from my perspective being a tech company, that's, it's our job, we're connected with a bunch of site networks and sites to partner with them, um, is, you know, we see the difference of the sites that it's their first time using tech like ours to do a decentralized trial versus the sites that we've worked with now for maybe the third, fourth or fifth study. Right. Cause this is all just technologies still, you know, within five years new, right. This sort of decentralized trial movement. Um, and to see the difference, it is substantial Brad. Like I agree with you. And I do think that, um, you know, from my perspective, you know, some of the things that sites can do, one is there's a lot of great content out here like this, cause a lot of this is education, right? So we, we have an education program that we've supported with sites and site networks to help them understand what DCT, what decentralized studies look like and how they work. Because there's also a lot of misinformation out there and we've heard everything like some people you come in and go, oh, I've heard of this. This is that thing that automates and cut sites out of clinical trials. And I went well, I'm so sorry that may be someone else's model. That's not actually how it works in the real world at scale globally. Um, and so, so I think too, you know, this ability to provide education is really important and there, there still is education needed on this front because you're right. Like, I think you hear about things, but only because you're out there up front you're you have a podcast you're on social media, more actively than some other networks are. And so I would say that the second thing though, is partnering with companies that are leading the charge in these more innovative approaches is one of the ways to get up front, um, in the process of change. And so for instance, like I would think about, you know, for us, like we have a partnership program, doesn't cost anything. It's where we actually, uh, partner with and help support sites. It's like networks that we've are working with around the globe to contribute and give them information and training about DCT also helped them to see how the platform works and also be able to put them out in front of some of our customers and sponsors and other people we work with to say, these are sites that want to be involved in these more innovative studies. They want to use these more innovative technologies and they understand what it is. And it makes, uh, the, the sites and site networks. It helps them to feel more confident, comfortable about these models upfront before they get to a study. And second is, it helps them to, you know, have some upfront education so that they also have that ability to sell themselves and position themselves as being involved in more of these, these programs that are having more innovative models altogether. So, you know, Brad, I think you're right. Everything is always slower than we want it. And we're trying our hardest like we're working around the clock to do this, but one of the ways that sites can engage, you know, it's finding these partners and getting to their education and like we have a bunch on threadresearch.com if there's interest. But the second thing is these partnership opportunities are also a good fit. And so, you know, if anybody was interested in those, they could always reach out to us and we'd be happy to connect them with our site partnerships.

Brad: Very good. Yeah. I mean, and just go back to your, you know, earlier when your earlier points there, I mean, I get, it is a good point that even for me, when I see, you know, discussion about decentralized trials, it does seem to mean everything from the idea of sightless trials to, you know, slapping a watch on somebody's wrist and everything in between. So, you know, and I don't know if that's just a lack of a solid definition or, you know, we're still figuring out what those combinations look like. Obviously there's no, there's not going to be a one size all solution when it comes to decentralizing trials, because you know, there's a lot of things you can't do remotely and a lot of things that you can, but I think that's maybe certainly one issue that maybe it needs to be better addressed is what do we really mean? You know, when we say decentralized trials, because again, I feel like that could mean near anything.

John: It totally is. Right. And you know, there's a, because decentralized trials during COVID sort of got, you know, advertisement, like it never had before to people who haven't been doing it for years, I've been investing in it for years. People who can put together a PowerPoint slide, all of a sudden they're trying to position themselves as experts in it. And I think you have to be careful there too, right? Like this is for us, this is our, this is what we do. It's not a side project in a way to get attention. Um, and I do think that, you know, when you're, um, when you're looking at where this moving you're right, I think the first three points on our training materials are all about, what's a decentralized trial, what are the different approaches it takes? And what does it actually look like? And, you know, there actually is a regulatory definition. It only took us years to contribute to it, to get there. And it, the word decentralized trial, um, is, is actually the technical term to be used. It's a regulatory term. And you saw it from FDA. You also saw it in the email publication around COVID. So, so there is, there is becoming standard terms and there are groups and people contributing a lot of time at a, uh, you know, at a lot of different levels to standardize these. But what I would tell you is, is that, you know, there just like anything that's moving and we hear this all the time and you're right, I've had a number of sites come in and say, oh, is this this model that replaces me? And I would say, absolutely not like the, the for thread it's the opposite. What we're trying to do is actually augment and support the sites in changing where and how data is collected. And there are a lot of assessments that need to be done in the clinic. They're best suited in the clinic. But as we all know, there's a lot of things that can be done remotely that could be done through telehealth limited through tele-health plus home health that actually are easier for the site and patient they're more efficient, not just from a cost perspective, they're more efficient from a completion percentage, right? So being able to do things and be more adherent and persistent to the data. But the thing for me, Brad, that's really important is when you think about the business model of the future, the reason you see major clinics and major institutions moving into hybrid decentralized models in the healthcare, not in clinical trials necessarily, but in this hybrid model is because it's a, some patients, some people are going to want to do things very remotely and some may choose to just come on in the clinic. So this ability to have flexible options provides a different model for sites to support with participants, but also know that a lot of these, these virtual visits and models, the reason you see a number of larger clinics and institutions moving to them, is there that from a clinic's perspective as a business who needs to make money and be profitable, these are much more is they're much more profitable. They're much more efficient units of assessment, meaning that your ability to, um, to have a more proficient or a more efficient, uh, revenue on a virtual visit is pretty high, um, because they, they do scale and they're a little bit more predictable and there's not as much admin cost around them. So what I would tell you, as well as that, I would say that this hybrid decentralized trial approach, this sort of mix of these things that then becomes fit for purpose in protocols, meaning one study does two visits like this, another study does eight visits like this because it's better for the site. And the patient is really the model that we see taking hold. And I think that's, when you think about a decentralized trial, that's really what you're talking about and then the features of it, or what you mentioned, right. Does it have eCOAS at a sensor? Is it a, you know, as a telehealth? Is it, you know, e-diary, whatever those components are, can be made specific to capture the, you know, the primary, secondary exploratory end points you need, in any given trial.

Brad: That's perfectly well stated. It is just that, I mean, it is every study is so different. Every site operates so differently, but having that ability, you know, to go as hybrid or, or not, depending on, you know, the appropriateness for the trial or patient population, et cetera, is really where, where it's at. I mean, you might be dealing with anyone from, you know, double amputees to people with headaches and, you know, those are two different patient populations with very different needs. You know what I mean? So going back to the idea that, you know, it's, it's, you know, not only good for patients, but it's good for business from a research site standpoint, you know, is that you can better retain and engage your patients and keep them in your trial collect better data. That all makes perfect sense. So I want to drill down a little bit more about what thread does specifically, and I guess my first kind of question is, are you guys more sort of aligned with the CRO and sponsor side or more on the site side, or really just sort of the, a hybrid of the two?

John: Yeah. So traditionally we've always been, you know, study comes in and they sponsor directly like a biopharma or a biotech, right? Someone who's conducting clinical trial, um, contracts with us, or, you know, they have a CRO partner who we work with or contract directly with. So we've typically been working there, um, as we've continued to expand our work, you know, we're now in, you know, almost 50 countries around the globe working with all kinds of sites and networks. Um, we definitely have had some more novel relationships and partnerships with sites and site networks, um, that are not just, um, trying to provide standards for, for, and sort of be pre-trained to do this type of work so that they can get this type of business. Uh, but also there's a number of sites and networks that, you know, act as their own, you know, site network that does their own CRO in some cases. And so they're able to do that. So I would say Brad for the most part, we've focused on this sponsor studies sponsored programs. Um, but we've definitely had unique relationships with institutions. And we, we actually had just a phenomenal opportunity to partner with and support a number of larger institutions early on in our company's history, you know, with UCSF and Stanford and Duke and Johns Hopkins and other, and other institutions like that in the US um, but what I would say is, you know, from our perspective, what's important to us, the mission of the company is that we're trying to change how research is done and make it more efficient. We're trying to make it more comprehensive, which means to capture more data points easier for patients and sites. And the third thing we're trying to do is make studies more inclusive. And, and what that means is we're trying to make sure that we can open up the geographic footprint, which we can recruit participants from and recruit people that actually represent our global populations in clinical trials. And so when we focus on those three parts of the mission and we focus really hard every day to make those come to life, um, what that means is that the partners that we have can be site networks, they can be the larger CROs, they can be pharma companies, they can be any individual, any company that's really trying to change how research is done, and fundamentally take that shift forward. That's who we partner with, that's who we really align well with, from a vision and mission perspective as well.

Brad: Fair enough. I'm curious to know more from, you know, your more sort of cite network or institutional, uh, partners, you know, if there's been much, uh, uh, pushback as far as adoption, when dealing with sponsors, you know, I feel like very much, and this has been talked about before, like as a site, you know, owner or manager, whatever it is you may be. I mean, it's a very much a top-down process. Sponsor says, here's your EDC, here's your ERT, here's your IVRS. And this is what you're using. And these are the tools you have. This is it. And, you know, even in instances where we've tried to include some sort of lower level, you know, technology, even CTMS trying to get some CTMS costs covered by sponsors to do remote monitoring visits, maybe as an example, uh, we get pushback, you know, from even major sponsors. Do you guys see, you know, pushback come coming from the top?Or, you know, eventually I eventually I have to see everyone kind of coming on board, because again, it seems like it's a, it's a win-win, you know, if we really get this stuff implemented across both sponsor and site, just like you said, we can include more patients, we can do it more cheaply. We can, uh, retain our patients and engage our patients better. But even now, again, I'm still seeing pushback from, from sponsors when it comes to sort of integrating site level solutions with what the sponsor provides. Is that a, is that an issue that you've, you've seen at all or been able to address in any way?

John: Sure. Yeah. I don't think we've been able to address it and make it better. I think the reality is is that, you know, here, the challenge you have is, and we typically are, are adopted centrally, right? Um, is that, you know, when you think about technology, there are a lot of different technologies do a lot of different things, but a lot of those technologies, some, some clinics, some sites may pick them and say, this works for me, and this meets my classification. But when you actually take that and you align it with regulations and you align it with regulations that are outside of the US um, what you, you, you know, what you have to realize, you could get into a place where you have 50 system, all capturing E-Pro all differently with different balance, different regulatory requirements, different cloud structures. And so the reality is you actually put the entire study at risk because the validation procedures, regulatory requirements are not being or not being achieved consistently across the globe. So when you think about technologies like this, um, you know, there's one side of the coin, which is what we're talking about, like document management and filing, right. I think that's an easier thing that we've seen more sites, you know, gravitating to and coming up with their own solutions. But when you're thinking about features like electronic consent, any eCOA, and telehealth where you actually do recording alive assessments, a health, more of these more complex features that require and have a very high regulatory standard to meet, um, and need consistency when they're submitted to regulatory agencies around the globe to get products approved. I think it's, it's ready to kind of have to cut the deck and say, there's some technologies I can definitely tell you. You can see that there's like a min-. I don't know what the right word is like a minimal standard to meet. And those can probably move in that, but there's a lot of other things that are really complex. And I think a lot of individuals don't understand the complexity of the, of the back office of those and how it works. So they just think, well, why can't I just use my tech to do this? Well, if you did it 50 other people did this way, your data would actually not have quality and submission in the study would be void. And so I do think there's kind of a, you know, like everything else in this world, there's, there's certain pieces of this discussion that I do agree with you, I think should move forward and be a lot more simple than we make it. But there's another side of this coin of complexity where some of these technology choices are getting, are we, I like that they're actually getting adopted centrally because it covers a lot of things when you think global and regulatory standards. And we just, we have to remember that we're doing all this work to submit data at a quality standard to get an approval. And that data standard is actually looks very different when you go global, not just when you focus on an individual site in the US

Brad: Sure. Yep. No, I mean, that's, that's perfectly fair. I just think it's, it's, uh, interesting to see how that gets or how that evolves, I guess as time goes on again, and eventually hoping that someday we get away from, you know, working with 15 vendors with, with 50 logins with all these systems. I just, I, I know that's a pain point for, for these sites. I mean, being at a site level for the last 12, 12 years, that's, uh, you know, that's where again, you know, I see the conversation. It's interesting. It's important. I think that obviously there's going to be change coming, but you know, at a site level, again, it feels a little bit harder to see the movement sometimes.

John: Yeah. And that's fair. I think, you know, maybe two other things to keep in mind. One is there are companies and we consider ourselves one of those, right. That's combined essentially seven systems into one that we built on and operate right to. And when we work with sites and I go, wait a minute, is all my stuff here? And we go, yes, it's all right here. We're pushing to make that change. And it's not easy. And it's going to take time. Right? It's going to take time for everybody to figure that adopt. So there are definitely that is happening in and Brad, unfortunatly, like everything else, it does take time in our industry. Right. And I do think that site's asking for it and pushing for it helps. It does. And I would tell any site listening to podcasts to not be afraid to raise that concern and ask for that, right. I want all this in one platform, because I do think that that is something sponsors and CROs are listening to, right. They want to know how to make it easier. They're not, they're not out there to do the opposite. They want to be supportive. And technology is shifting right now. And I think now's a good time for that. You know, the flip side too, is, is that you, I think that utopian vision of, you know, there is only one to two systems and they cover everything. Um, it is also also a negative meaning. If, if we came out and said, Hey, the only two places you could shop are Amazon and Walmart and everybody else's closer business, the amount of support, the amount of, um, customer to witness and experience you would get from those two companies would drastically decrease, which means competition actually makes things better. And so you're right. Like, I think there's this balance that we're in. And remember, we're in a really unique moment right now in our industry where we're seeing tech evolve COVID has accelerated a lot of that. And I would tell, um, you know, any sightings that network that's really thinking through this is to be vocal about it, but also to, to get out there, just spend a couple hours in advance and figure out where they can get into those decision making processes upfront, um, with those partnerships. Cause they, they they're there. And right now people really want them, like, we want that feedback. We want to be supportive of sites. This is not a, you know, it's a very collaborative moment in our industry that should be taken advantage of.

Brad: Yeah. And That is a fair point. I mean, there's, there is obviously a lot to be said about diversity in that. I mean, just like where I'm at in Oklahoma city, like, uh, you know, there's a large medical university that does research and then there's a smaller group like me, well, we can provide very different offerings. Right. And you wouldn't want just one as opposed to the other, you know, we're, we're very lean and flexible and can adapt. We can go into any community and set up shop and perform a research trial, uh, as opposed to large institution where, you know, they've got the, uh, they've got the name behind them. They've got maybe some better infrastructure in some cases. It, although it may take them a longer to get going, but they've got more, uh, academic focus. So yeah, I mean, I think there is a lot to be said about some diversity end again, the fact that right now it might be a little bit of the wild west where we've got all these companies popping up kind of trying to solve the same problem. And then, you know, as things sort of sort themselves out as they do, uh, you know, you'll start to see some, some real front runners and things will become a little bit, you know, uh, I don't know if consolidated is the word, but maybe a little less diverse than what we're seeing right now, where it seems like everybody's popping out of the woodwork saying DCT, DCT use, you know, et cetera. So

John: Yeah, I hear you, but I think that too will flush itself. I think we were trying to say, and I agree, I it'll flush itself out because, you know, um, companies that have made decentralized trials and changing research, a fundamental part of their company, right. They've, they've, they're, well-funded, they've grown, they're here, you know, like, like us, you know, we're, we're going to continue to mature and move forward. Um, companies that maybe this is just, um, not their core competency or something that just happens to be a moment in time to take advantage from a marketing perspective. I think all that will flush itself out as we sort of come through this next curve. Um, so I think you'll see like that. I, again, I would be really at what I would tell you is if I'm a site I'm just asking questions and being cautious and careful and just being inquisitive. And so, you know, again, just a couple of markers, do you want to know who's doing something in decentralized trials? You know, how many studies or have you done, how many countries are you working in? How many sites and participants have you supported the platform questions like that are, you know, experience related questions, especially in today's world go a long way. And I think really digging into those to say, wait a minute, is that really a DCT approach? Or is that just, you know, you collected a document in an E-source, right? Like those inquisitive questions go a long way, because what you'll find is that the, the difference between those providers is pretty large. Um, and so, yeah, so listen, I think, I think it is, we are in a moment in time as well, and you're starting to see the stable growth. And so, so sites that are doing it, you know, who we capture surveys and scores with, uh, are continuing to learn, continue doc, continue to scale it. And we do have a large range of sites that are doing their first and second decentralize trial. Right. And so it's just like everything else, you know, as you start to do this and you start to use it, it becomes an adoption model, right. It becomes an approach, but I just want to be clear, you know, a decentralized trial. It's not, it's not necessarily a trial design. I think you, you said it really well. It's an approach that you put into a study to make that study work differently, to change where and how data is collected. And when you lean into that, I actually think about what we see from sites. There's a lot of practical nature of using tech to actually do DCTs really comes to light. Like we have, you know, study coordinators are like, this is so practical. And like our, our patients expect this, right? So like those types of terms, those types of responses and things that, that are really valuable because that intuitiveness of, of how it works, that it does actually make things go easier or more simple is what we're all trying to achieve. And I think that's the journey everybody's on and right now is a real critical moment for that, uh, for that journey.

Brad: Yeah. No, I mean, there's no question is it's super exciting time. I mean, I can't open LinkedIn without seeing a conversation about decentralized trials. So, you know, it's, it's, we really couldn't be in any more, uh, of sort of an exciting time when it comes to this. I'm, I'm interested to see how it shakes out again, the sort of being at the, at the level that I'm at, where it's sort of watching, watching these conversations and being, uh, you know, maybe a little more of a bystander than I'd like to be, but still, you know, just cautiously, cautiously optimistic that, uh, you know, w we start to see some real, uh, strong change. It's not that we haven't already, but, you know, continue to see the trajectory that we're on. So, you know, I love what I'm seeing. Um, if I can digress a little bit, uh, I'd like to say, you know, talk a little bit about, you know, maybe, uh, another question I like to ask all my, uh, people I interview here is what are some resources that you use, uh, in your job that you'd share with other people in clinical research, whether it's, uh, you know, books, software, or process, what are, what are some things that really provide some value? It might help provide some value to, uh, others in the industry.

John: Sure. Yeah. Uh, there's a lot, I would say that, um, when I think about the first point and not to, not to kind of plug here, but the, the world of podcasting is, you know, when I think about podcasts in our industry focused on clinical trials. And if you ask me this question five years ago, I'd say I kind of know one, and it kind of is infrequent and, you know, fast forward to today, there's just a wealth of resource and discussions around clinical trials, and what's happening them in a series of podcasts from individuals. And all you gotta do is go into the podcast app, wherever it is, and, you know, and just type it in type in clinical trials type of clinical research. And you'd be shocked at the amount of content that's out there that's completely free and really helpful and useful. So I actually think that's a great resource, especially if you're an audible learner, right. Like me, I like to listen to books more than as much as I like to read them. And so I think that's one area that's really, really important to think about. You know, the other thing that, that I would say is a resource that's maybe a little, I don't know, maybe a little non-traditional is, you know, when you think about books that have been really helpful, sort of in a journey, I, there's a couple that I really like, and I'll just call those out for you for, for your listeners. Um, one book that I think actually would be really unique for sites to listen to. And it's talking about how you are perceived in the market is a book called Fascinate it's by an author called Sally Hogshead. She's just a brilliant marketer. Um, but it, but really focuses on helping to how you convey your messages and how you are perceived. And I think in our industry, you know, we have to understand that, that we had this advantage that happened right now is that, you know, more than ever, you know, as the vaccines were getting developed, um, my neighbors, my family, if I don't know about you, Brad, it felt like a lot of them said, oh, I know what you do now, because I'm hearing it on the news all the time, right. You guys are going to work to go get research to happen, to get COVID vaccines into the market. Right. And, and, and so what that did is it, it brought to the forefront, what we do. And we all know as, as a site and as a, as a network, you know how you're perceived by sponsors, how you're perceived by Ciro's, but more importantly, how you're perceived by participants that may or may not be, you know, open to participate in a clinical trial becomes really important. So anything around that is, is helpful. So again, that's kind of one book I would recommend, uh, to think about the other one that really comes to mind for me is, um, you know, when you think about the adoption of, or what the regulators are saying around decentralized studies is really important in our industry. So it's one thing for you to get education. It's a second for you to read, you know, books and materials that are outside of the scope of, you know, life sciences to bring those thoughts and processes in. But the third thing is to look at what are our regulators saying on these topics? And there's a lot being said. And so one of the resources, if you want to go to threadresearch.com and you can click on, I think it's newsroom on the site and we have provided a ton of materials. They're not, they're not nothing to do with like sales materials, they're all educational pamphlets. There's some reports on how decentralized studies are working with caregivers and east source and what the regulatory bodies are saying. And so if you ever want to know about decentralized trials, we build a resource for that on our site, just in it's free just to help you see what is going on, uh, in the market. So that's kind of maybe, you know, lots more to say there, Brad. But then maybe that's the three big kind of topic areas that I would throw out as ideas to explore.

Brad: Sure. Nope.Nope. That sounds great. So, uh, tell me a little bit about where people can find You online?

John: Sure. The best place is really two things. One, my company thread is at threadresearch.com, lots of materials and content there. If you want to find me personally, it's John Reites and I'm, uh, maybe the best place to find me is on LinkedIn. So if you just LinkedIn, uh, backslash John Reites, and yeah, I'm always happy for you to outreach and let me know if I can help. Um, and if you're interested in learning more about any things I mentioned today, uh, happy to connect you there.

Brad: Awesome, John, again, I want to thank you for coming on. I'll make sure we'll post your contact information in our show notes to make sure people can get ahold of you. Uh, definitely check out threadresearch.com. All right. Anything else before we go,

John: Brad, thanks for coming on. Note to file. Love the podcast, love what you're doing. Thanks for putting in the time and work. I think a lot of people don't understand how much work and time podcasts take to make. Um, and that's your, you know, your night and weekend time that you're spending as you're running is running your own institution. So thanks for what you're doing. Thanks for bringing the content to all of us. It's really helpful. We appreciate you.

Brad: Well I love it. And I appreciate it. Thanks again, John.

John: Thanks Brad.