There are still great barriers to participating in clinical trials, which need to be brought down!
In this episode of Bite the Orange, we have Brad Hightower, CEO of Hightower Clinical, a company focused on increasing access to clinical trials by creating community partnerships and reaching out to physicians, hospitals, and medical groups to offer no-cost research infrastructure. Brad talks about his mission and how Hightower Clinical works with enrolled patients, ensuring they are informed about all the risks and benefits of participating in a clinical trial. Challenges like overestimations of patients in sites, qualifications, diversity, and location are some of the barriers that Hightower Clinical is working to improve, and Brad explains exactly how through examples. He also shares his thoughts on decentralized clinical trials and technology’s role in them, sharing his company’s experience on the matter, flexibility, and what he calls "low-tech" DCTs.
Tune into this episode and listen to how Brad Hightower is increasing access to clinical trials!
FULL EPISODE
BTO_Brad Hightower: Audio automatically transcribed by Sonix
BTO_Brad Hightower: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Emmanuel Fombu:
Welcome to Bite the Orange. Through our conversations, we create a roadmap for the future of health with the most impactful leaders in the space. This is your host, Dr. Manny Fombu. Let's make the future of healthcare a reality together.
Emmanuel Fombu:
Good morning, good afternoon, good evening. Ladies and gentlemen, thanks for taking the day off today to listen to us. Today, we have another great innovator of beautiful show and amazing show Bite the Orange, and I'm sure you're part of the movement. And as you know, the only people we talk to are people that are doing something innovative in the particular space that we care about, and that's the space of digital health innovation. And today we have someone with thousands of followers, someone I followed for a long period of time, and I'm honored to actually have him on the show today. And that is Mr. Brad Hightower, CEO of Hightower Clinical. Welcome to the show today, Brad.
Brad Hightower:
Thanks, doctor Fombu, I really appreciate the opportunity.
Emmanuel Fombu:
Now, thanks for joining us. So I will start off by, you know, we have many audience members that I have never met you, I mean, those that know you. So tell us something about yourself.
Brad Hightower:
Yeah, I mean, you know, I started out, my focus is in clinical trial sites, right? So I started out almost 15 years ago at an academic site, realized pretty quickly that it's pretty much the model of inefficiency when it comes to delivering clinical trials and getting patients involved in clinical trials. You know, you're looking at really long timelines, big bureaucracy. You know, eventually, I was able to move on to a private hospital. I became the director of research for that. And, you know, we saw some increased efficiency, and all the while I was talking to physicians in the community, and it was occurring to me that there's so much in so many underserved communities and physicians in terms of clinical trial opportunities. So really over the last four years or so, I've set out to create some community partnerships and provide a research infrastructure to physicians, hospitals, medical groups, and able to get out into more rural areas, be able to get out of the sort of consolidated academic medical centers and really just be on a mission to go provide clinical trial opportunities where they don't currently exist. And maybe as a dovetail to that, make the barrier of entry for physicians as low as possible because frankly, it's a challenge, right? That's why they live in these big spaces, because, you know, it's very challenging to find the infrastructure and the knowledge to undertake these things. So that's been my mission over the last four years or so. And we're slowly, slowly scaling out and trying to get more people involved in the clinical trial process.
Emmanuel Fombu:
And Brad, thanks for that background piece of this, and just to highlight something very unique about your particular background, right? Like I have designed clinical research more from a clinician kind of perspective, right? You come from kind of the grassroots of this operation kind of perspective. There's a very unique kind of perspective that I could talk about clinical trials, but you could have a complete different perspective of what happens on the ground. This is like boots on the ground kind of stuff we're talking about here, right? It's a grassroots kind of movement. And so for those people that have never been involved in clinical research and they hear about research in general, right? And this is about P values or whatever it is, it's about sites, what happens on the site level, right? So if you could give us like a brief kind of background for someone that has no idea what clue what this is. What happens in a traditional clinical site, what are the challenges, and what are you solving?
Brad Hightower:
Yeah, I mean, essentially, you know, sites are contracted by pharma or device companies to find patients who meet the criteria in which a drug or device can be tested and evaluated for safety and efficacy. So we're essentially working with patients which are called subjects once they enroll into a clinical trial, but we're ensuring that they're informed about all the risks and benefits of participating in a clinical trial. They have to be educated about not just the particular drug or device itself, but also what clinical trials are and what goes into participating in a clinical trial. And we're essentially following them all throughout the course of their treatment with this investigational drug or device. So that oftentimes involves multiple visits to a site, which might be a physician's office, and in most cases drawing blood from them or giving them EKGs, ensuring safety. And we're collecting data on their outcomes, whether they be quality of life or other types of outcomes. So it's, this is a, that's a very high-level sort of way to say it, because frankly, there's so much nuance that happens at the site level. And I love that you point out the sort of existing gap between maybe industry experience and site-level experience because I think that's a big problem that exists. But to digress, you know, we spend.
Emmanuel Fombu:
Because you brought that up, just to relevance to it, my first-time exposure into this and I think you're very tied into what you were trying to say or not, when we designed clinical trials initially, I remember reaching out to my ops team and we said, Hey, we deployed this study, right? And I waited for the first month and we had to qualify sites to make sure the site actually had the right number of patients that we had, right, to make sure the patients didn't fit the inclusion-exclusion criteria in that particular piece. And then you have, you know, CRAs that go out to validate sites and look at the whole process that goes through it. You kick off a particular study and then sometimes you find out that not every site that you qualified actually has patients, right? And they find out it's the same sites that recruit all the patients, right? And then you have one site has multiple studies and these sites are all the same exact location, correct? That's something that you've encountered as well?
Brad Hightower:
Yeah, for sure. Again, there's a lot of nuance that goes into it, and I think a lot of times there's a disconnect between what sites think they can do or what they think they have on as part of their patient population. And sometimes we miss, you know, and sometimes we over-enroll. I think I can sympathize with someone in your position to right and spend blood, sweat, and tears on a protocol design only to see sites sort of fumble the ball, right? And I think that's something that continues to happen. I mean, it's still a big problem. A lot of studies, you know, enrollment gets extended or new sites have to be brought on. I mean, that's certainly a continuing issue. But I think a lot of that is because it is such a, almost chaos sometimes at the site level when you're trying to manage these complex protocols.
Emmanuel Fombu:
And with that being said, so in your experience from working, what made you start your own company, right? I mean, the clinical trial sites already existed. You've been there for some time. So what was the problem that you were out there that you're out here right now trying to solve?
Brad Hightower:
Yeah, I mean, for me, it was about the fact that there are, especially in Oklahoma, there's a lot of rural area and there's a lot of community physicians who would love to offer new treatment, potential new treatment options to their patients. There's also, we all know there's a big lack of diversity in clinical trial enrollment. So to be able to go into communities and provide support that these large institutions just aren't able to. Again, to me it was just this creating a win-win-win situation, right? It's a win for doctors, it's a win for patients, it's a win for drug development as a whole. If we can better make community partnerships, we can move faster, we can enroll more diverse, we can complete everything quicker, we can be a lot more agile. So again, I just thought there's a better way than sort of consolidating amongst these big institutions and really being able to go out and help more people. And something I, obviously remain pretty, pretty passionate about, if you follow any of my LinkedIn material.
Emmanuel Fombu:
Correct and, which you are very active on, and this brings me to the next question around this whole world of decentralized clinical trials, right, which is a big thing that people talk about. But I like your approach in several ways because it's still decentralized in an interesting way, and so is of interest a unique approach that you take. In one of my roles, you know, in previous organizations I worked for, I remember we ran a clinical study and we did, we spent about a couple of million dollars, you know, for ads, but we made ads in rural areas, but we had no sites in those rural areas, right? And so the enrollment was low, and so the question was, why are we spending all this money running, running ads, TV ads, newspaper ads, radio ads in areas where we don't have sites, right? And because other sites are the major areas in major cities, but everyone with those diseases are not located in one particular area, but they could be wherever, or they could move. Someone could be in a big city and they could move to a rural area. So what happens to that person when they move, right? They can start one place and that leads to dropouts in clinical studies. So at Hightower Clinical, how do you go about solving this? How do you set up your site? So what makes it different how you do it?
Brad Hightower:
Yeah, I mean, interestingly, I sometimes refer to what we do as low-tech DCT, right? Because we can spin up a site anywhere. And if, especially, if we have intelligence and data that says like, okay, well there's a large subset of this population and in this rural area, we can go spin up a site at no cost. So we do, our partnerships don't cost the physicians anything. We split study revenue again in hopes and trying to encourage lowering that barrier of entry for physician practices because it's expensive, can be expensive to run a clinical trial program, and frankly, the revenue cycles are extremely long. So, of course, we use technology, but for us, sort of my pitch in a way is like we're low-tech DCT. Where are the patients? We can go there and spin up a site in a matter of weeks, if not even days, right? So we don't have to rely necessarily completely on technology. We can still have that human touch, and as you well know, I mean, there's a lot of communities who are skeptical of clinical trials and are going to be even more skeptical if there's not a human face behind it. So I think that in that way, we're able to be a little bit more adaptable and flexible than maybe a pure DCT model.
Emmanuel Fombu:
And that brings me to the point about the technology piece. I like a better part of technology, right? It's very funny, I just spent my career, if I talk to someone about anything and about my background or healthcare, they go digital health guy or digital innovation person, but also in the medical school, I also understand biology and things are studied, right? It doesn't mean that because I'm interested in role of technology, it means that we can think past technology, and you find that technology has become a barrier in how we think through DCTs, because the concept of DCTs is only a technology thing, right? So technology could make could facilitate that process, right? And it could be technology studies that could be done using your less technology model that makes it more effective as well, right? Do you find that as a challenge?
Brad Hightower:
No, no, I mean, I think it's a, we're in a weird space in DCT right now. I think there's a little bit of a, I don't want to say a battle, but an internal struggle between being fully decentralized and then being sort of hybrid or more traditional, right, and I think there's no reason that the two can't perfectly complement each other. I don't think we found the balance quite yet, but I think that's incumbent upon our success in sort of furthering and improving the clinical trial process. I mean, there are some studies that are ripe for full decentralization via technology, subject to patient registries and things like that. They make perfect sense, but when you're administering investigational medication or obviously there's still surgical trials that exist, certainly can't do remote surgery at this point. You know, maybe, maybe someday, way, way in the future, but I think we can find a better balance between the community partnership model in conjunction with decentralized technology. I just don't think we found that seam quite yet, but I'm very hopeful that that will sort of make itself more clear as the dust settles in a very, very competitive space right now.
Emmanuel Fombu:
And I think that will happen. I remember several years ago at a time when we had IBM Watson being like the big thing that was going to disrupt AI in healthcare, right? Everyone was AI in healthcare, and Watson was going to do this and replace clinicians. And every debate you had, even on LinkedIn or any community you went to was do you think that AI would replace doctors? And every answer would be, Oh no, it would not replace doctors who would do this, and that's the same debate we're having, right? Now no one talks about it anymore, now, we're moving forward. Now I see the same kind of discussion taking place in a DCT place where instead of discussing the overall value and outcome of what we're discussing, we're wasting time talking about nonsense. And when I say nonsense, I purposely meant to say that word because we were debating things that are irrelevant to the belief and concept where we're trying to go, right? Having a debate with anyone about is it fully technological or whatever is fully or is mixed. Who cares if, it's irrelevant conversation, right? It's like saying, can you buy your groceries online, go to a grocery store. Who cares? What makes it convenient for you?
Brad Hightower:
Right, right.
Emmanuel Fombu:
Exactly, you cook at home, you eat out. It's some kind of conversation. But the question is who this focus on the outcome? What is the purpose of the study? And that's what we should focus on. I think we can move forward with that. Do you have thoughts around that?
Brad Hightower:
Yeah, no, no, I agree 100%. I think, again, we're still in a place where we're trying to sort of slap technology in where it's maybe not appropriate yet, but again, I think we're just in that sort of part of the cycle where we're learning our lessons and I think it will sort of fall back to earth in terms of, again, it's about patient outcomes, it's about the data, it's about the patient optionality, you know, which which is still super important because there are still great barriers to people participating in clinical trials, and we do need to fix that. I mean, there's no question about it.
Emmanuel Fombu:
And to add to that, I was in Toronto, Canada, actually a couple of days ago, and I was having a conversation with some colleagues and I had a discussion around the reason why it was difficult to have decentralized clinical trials is because we couldn't have the same blood pressure cuff everywhere, measured in people. And I said, today's clinical trials, our blood pressures are not measured by the same blood pressure cuff, right, all, or height, weight, that different variables in those things that we do, right? So it's not like it's like same equipment across the board. So you have the right, I don't care if you measure up the blood pressure in a doctor's office or at home, right? The point is, I need a measurement, of the blood pressure.
Brad Hightower:
Right, right.
Emmanuel Fombu:
Which a lot of people miss that point of what happens in a particular case. So they think that everything must be uniform and that you must come to doctor's office to do things. Like your medicine, for example, you could pick up in a pharmacy, or I could deliver it to you. At the end of the day is, what was the effect of the medicine on you, right? So you see this adaptive kind of clinical design of studies that I think someone from their position, it'd be very helpful to have someone like you involved in the design of clinical trial protocols. So my question being, have you been involved in any of this? Is that something you're advocating for?
Brad Hightower:
I mean, I'd love to be more involved. I have seen and am encouraged by some of these DCT companies reaching out to people at the site level. I'm seeing more of it, and I think that's a huge, just a very smart way to go. Because, again, I mean, what you described even is interesting because the way sites operate and the way that sites are sort of regulated by CROs and sponsors and even the FDA is, needs to either change or be sort of reimagined, I believe, in a decentralized model because to your point, something we have to do at the site level is calibrate every single piece of equipment every year, and there's some, it's creating some sort of standardization there. So if you decentralize now, does that mean if you pick up a blood pressure cuff somewhere, does it not need to be calibrated or does it still need to be calibrated according to some standard? But I mean, I think that's a fair question to ask if we're going to go down this road, right?
Emmanuel Fombu:
So I guess the question there, Brad, is about calibration, about location of the device, correct? I mean, that's what, if we debate the location here, we will talk.
Brad Hightower:
It doesn't matter where it's at.
Emmanuel Fombu:
Correct, but the calibration, I agree, we should calibrate them because it creates that even around the location of that device. I don't care if it's in Oklahoma City or in New York City, right?
Brad Hightower:
It should be the same.
Emmanuel Fombu:
Correct, if you're a patient and you happen to travel and you are in Oklahoma instead of here in New York City where I am, it doesn't mean that you're out of the study because you decide to travel that week, right? You took a device here if you could calibrated and you could measure the same level, you should be able to take a blood pressure measurement, for example, right?
Brad Hightower:
Perfectly fair, yeah. No, you're right, you're right. But I think those things need to be accounted for if we're going to go full, full decentralized, which again, I don't think is out of the question. But again, to your earlier point, I'm encouraged by the sort of further collaboration we're seeing between these sort of new emerging tech companies and then the people who have been working at the site level for decades. So I think it's good, it's a good thing, and I hope we see more of it.
Emmanuel Fombu:
So perfect, so this takes me into understanding how Hightower Clinical works. So let's say I have a study because I know I went on your website earlier. You could search clinical studies, you could reach out to your team to get response, I understand. So let's say I have a clinical study. So if an audience member works at a pharma company or a medical device company or whoever wants to run a study and I reached out to Hightower Clinical, how does that work? And for an explanation of once you get the protocol, what the discussion is like, how you recruit your sites and how that all works together with ...?
Brad Hightower:
Yeah, I mean, very likely we're going to look at the sites that are already within our network and try to match that patient population as best we can or physician specialty, obviously, you know, we try to be very careful and pragmatic and realistic about the patient population we have. I'm sure you've encountered, sites like, tend to overestimate, you know, how many patients they can enroll in a trial.
Emmanuel Fombu:
Very common.
Brad Hightower:
It's extremely common, extremely common. That's a whole another, I think, yeah, the origin of that is maybe a whole nother podcast topic that might be interesting, but yeah, and then if we are looking at study opportunities outside our network, you know, the beauty is that we've got a lot of inroads with other community physicians and physicians that are part of systems we're already in, and which we can go potentially spin up new study opportunities. So again, we have a lot of resources and a lot of kind of opportunity to run with, but from there, it's a fairly traditional process in terms of completing feasibility and ensuring we have coordinators on the ground to support from there.
Emmanuel Fombu:
Ideal target clientele. So are you targeting CROs? Are you targeting the sponsor of the study, or do you have to do your own net physician network as well? Correct, so who's your target customer?
Brad Hightower:
Yeah, I mean, probably I mean both CROs and sponsors, whoever's got a good clinical study here, I want to be friends with you, right? And then on the other end of things, we're continuing to partner with smaller independent private practices and at the same time work with some larger healthcare systems as well, where you really start to sort of get the economy of scale, you know, with some of these big systems, and we don't have to go make third-party contracts for other imaging and whatnot. Everything is right there kind of on-site. So I'll continue to sort of diverge across both models, I think it's really important to not turn our backs on these smaller independent community practices, which still have great relationships in their communities and serve a lot of patients.
Emmanuel Fombu:
And while we're at that topic, what is in for the hospitals and health systems to, you know, to participate in clinical research, right? So a lot of these hospitals are independent clinical practices, they might think is a burden for them or I'm wasting time, my staff's time, and all this. But what is the advantage for them? I know what it is, I mean I figured some financial benefits for them because you mentioned revenue share kind of perspective. So tell me how that works. If someone is listening and is your provider in a small private practice or you are in other smaller health system, they want to that's not necessarily equipped for clinical research, what is it for them?
Brad Hightower:
Yeah, so I mean, we bring the whole thing to them, right? All the equipment and everything that's necessary. All we need is a little bit of space. You know, we provide a coordinator, we provide all of that administrative support in terms of finding good study opportunities, going through feasibility study startup budgets and contracts, but it enables them to continue to treat their patients. You know, we want it to be a continuum of what they do, not an interruption to what they do. So we have investigators that participate for numerous reasons. I mean, obviously, some have legitimate scientific interests, and new molecules that are becoming available, or simply altruistic in terms of wanting to offer new solutions or new treatment options to their patients. Certainly can provide, in some cases, a very lucrative revenue stream depending on the types of trials that are done. And then a lot for a lot of these guys, it can help them become key opinion leaders by getting their hands on sort of the newest and coolest devices and drugs. So again, we want to make it a win for the practice and again, a little as little burden as possible.
Emmanuel Fombu:
And, correct, and it's also a real-world piece, right, because a patient probably goes to that clinician already, right, it's not enough to travel extra miles to go out of their way to secure ...
Brad Hightower:
Absolutely.
Emmanuel Fombu:
Right, and a patient also gets to stay within that help network, right?
Brad Hightower:
And for us, it's important that the physician has, there's still standalone research sites and those are perfectly fine, but I think there's a different level of accountability and ownership that a physician takes when it's integrated within their practice. They take some pride in accountability in that, and it also makes their life easier because they don't have to drive down the street and see a patient.
Emmanuel Fombu:
Correct, and then is there a financial benefit to this? I mean, overall, we have, you know, the nonfinancial benefits, but hospitals, institutions, and providers, you know, it's an opportunity to actually make additional income here, right? Because you mentioned the testing piece, right? They have, let's say you have a study that requires an MRI, a CAT scan, or an echo. Everybody thinks blood draw and they have, labs and all those things, they do financial incentives for them as well.
Brad Hightower:
Yeah, of course, so aside from just the per-patient study budget, to your point, there's also sort of the halo effect, as you might call it, in that there's other procedures that are being done, the colonoscopies or maybe cath lab time that's being paid as well. And these institutions aren't, have to carry aren't having to carry any more FTE. We provide those, those boots on the ground, so it's never going to be a money loss. It's always going to be a fair percentage of study budgets that come in for them. You know, we've had clients that we've been able to make them, you know, seven figures in six months. So, I mean, the opportunity is extremely, the ceiling is very high in terms of potential revenue stream.
Emmanuel Fombu:
That's definitely value-based healthcare, where everyone gets value out of it, right? So it doesn't matter if it helps us to make a value out of it. If you're a patient, you get value out of it, right? If you were a sponsor of a study, you get value out of it. And most importantly, the patient gets a lot of value out of this convenience top quality of care, which I think the whole idea of the decentralized clinical trial idea, it's about the patient at the core of it, right? What makes it convenient for that particular patient? And we build the studies around the patient to make sure everything is value for them. And so with that being said, I would like to ask one question before we wrap up here, Brad. What has been the biggest challenge you've faced so far at work in this particular space? Because for us it makes sense what we just said, right? And we don't understand why everyone is not adopting this and why everyone is running away with this. What is that challenge?
Brad Hightower:
Yeah, I mean, it could it's twofold. One, to your point, I think it can be challenging to, for big institutions to immediately understand the value without sort of seeing it as a liability. I think that's still a little bit to overcome. But then secondly, something I posted about recently, too, is I think it's a challenging model to scale simply because I think so much of what makes clinical trial sites successful are doing the things that don't scale, which is finding and building the relationships with the practice and with the physician and making it a positive experience for research patients because frankly, they have to want to come see you, they have to want to be involved in your trial because you're asking a lot from them. DCT is trying to solve this, but there's still a burden for patients. So we have to be very cognizant and intentional in how we build relationships and sort of personalize the service to the physicians and communities that we work within. And I think that can be challenging because you sort of have to reinvent the wheel a little bit with each community and with each partner that you have.
Emmanuel Fombu:
And that's a challenge that requires someone to bite the orange and definitely think different here, right? So thanks, Brad, for being on the show today. I hope to have you back again. I think there's several topics that came up today that would like to explore further with you and another day in time. But thanks for listening, everyone, and please, we all support what Brad is doing. So if you are a CRO or you are a sponsor of a clinical study, if you find Brad's services beneficial, which I think they're beneficial, I understand why they would not be beneficial, right? You could definitely reach out to Brad. We'll have Brad's information on the post of this link, on this podcast, his contact info, and the link to his website so you could reach out to him directly, but please let support Brad and make sure that this movement is behind Brad to make sure that we make the future of healthcare a bright one. Thank you, Brad, and thank you for joining us today.
Brad Hightower:
I appreciate the opportunity. Thanks, Dr. Fombu.
Emmanuel Fombu:
Thank you for listening to Bite the Orange. If you want to change healthcare with us, please contact us at info@EmmanuelFombu.com, or you can visit us at EmmanuelFombu.com or BiteTheOrange.com. If you liked this episode and want more information about us, you can also visit us at EmmanuelFombu.com.
Sonix is the world’s most advanced automated transcription, translation, and subtitling platform. Fast, accurate, and affordable.
Automatically convert your mp3 files to text (txt file), Microsoft Word (docx file), and SubRip Subtitle (srt file) in minutes.
Sonix has many features that you'd love including collaboration tools, automated subtitles, powerful integrations and APIs, transcribe multiple languages, and easily transcribe your Zoom meetings. Try Sonix for free today.
About Brad Hightower:
Brad lives, works, and podcasts from Oklahoma City, OK. He has worked at the site level in clinical research for 10 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation. Brad has since started his integrated site network, Hightower Clinical, of which he is the CEO. He hosts the Note to File Podcast, a podcast for clinical research sites - interviews, best practices, and candid commentary. His latest website, Clinical Trial Confidential, is a web forum for people who can come together and increase transparency at the site level. He got his Bachelor of Arts from the University of Oklahoma in 2016.
Things You’ll Learn:
Hightower Clinical’s partnerships allow them to be more adaptable and flexible with some studies than what a pure DCT model entails.
Some think DCTs require uniformity in equipment and technology when only equal calibration is necessary.
Surprisingly, not every qualified site for a study has the necessary patients.
There is a big lack of diversity, equity, and inclusion in clinical trial enrollment.
Hightower Clinical is working towards finding a balance between its community partnership model and decentralized technology.
Brad’s company provides not only research infrastructure but also coordination and administrative support.