Research Confidential_Brad Hightower: Audio automatically transcribed by Sonix

Research Confidential_Brad Hightower: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Joseph Kim:
Welcome to Clinical Research Confidential! On this show, we highlight and demystify the inner workings of this greatly misunderstood activity called clinical research. Now, why is clinical research important? Well, it’s the basis for nearly every modern remedy for sickness and a growing method to build trust and solutions meant to optimize health. But it’s not for the faint of heart. And so on this show, you’ll hear what it really takes to succeed in the clinical research game. I’m your host, Joseph Kim, and I’ve spent over 23 years in the clinical research industry now serving as the chief strategy officer for ProofPilot. Get ready for some adventures as we look into the underbelly of clinical research.

Joseph Kim:
Hi, everyone! Today I’m here with Brad Hightower of Hightower Clinical Research. Brad’s been making a lot of noise on LinkedIn in the clinical research community, and I frankly love it. I think a lot of it is truth to power. Brad, welcome to the show, it’s great to have you!

Brad Hightower:
Thanks, man. I appreciate you having me on.

Joseph Kim:
Yeah, so looking at your background, you’ve been in sort of the clinical side, clinical research industry for quite a long time. You’ve had a number of different posts and responsibilities through academia and industry and so on, give us a little history of how you got to be the CEO of your own research enterprise.

Brad Hightower:
Sure, I mean, I started out, like a lot of people do, sort of fell in by accident. I had a friend who was leaving a research job at the local university and recommended that I go give it a shot. At the time, I was supervising a plasma center, so I had some nice transferable skills, I could draw blood, you know, had some experience with proper documentation practices, and I landed the job. And actually, at the time I didn’t have a degree, so I started at bottom of the barrel. I was a research assistant in a very small neurology department that didn’t really have a whole lot of trials going on. And again, like so many people, I didn’t really get very good training, it was kind of a trial by fire. The two coordinators who were there left, so I was kind of left to figure out, figure it out on my own, and kind of pick up the pieces. And even though it was challenging in a lot of ways, it was great experience because I really got to see the full perspective of what happens at a research site from identifying trial opportunities, negotiating the budget, taking care of IRP submissions, all the start-up process, and then obviously coordinating the studies from there. So I worked in academia for I think four or five years. I worked across the street at the VA a little bit as well. I realized pretty quickly though that academia is not for me. It was very inefficient, there were just a lot of problems with the alignment of incentives for some of the physicians. So I got out of there just about as quickly as I could and moved on to a physician-owned hospital who had a nonprofit attached to them that ran their research. So I was like, great, I’m in a little more private setting, this is going to be cool. And there were a lot of benefits to it. We could use a central IRB, we weren’t waiting for six months for IRB approvals or for budgets of contracts to be negotiated. The problem there was that the physician engagement was just, again, very, very minimal. They didn’t pay their physicians for their research time, so they’d rather be in the cath lab doing procedures, making money. So I actually pitched to the organization the idea of going out into the community and working with some community physicians, offering research infrastructure and sort of rolling them up under that nonprofit, didn’t catch on, they really weren’t interested in it.

Joseph Kim:
Did you get any hate mail from that or was it just, no, thank you?

Brad Hightower:
No, I think it was just sort of the concept wasn’t well understood. You know, they didn’t really see how it made sense, which is perfectly fine. Even now, a lot of people don’t necessarily understand how a model like that might work. But in the meantime, I was talking to all these community physicians and realizing they want to participate in clinical trials but don’t have the infrastructure to do it. We know like the barrier of entry is very high, it’s a problem, right? So, you know, we hear the stats like so many physicians have, do one trial and quit. You know, it’s crazy. So what I really wanted to do was provide that infrastructure for free. So no charge upfront to work with these physicians and we’ll split study income as it comes in. So we’re building a long-term investment in creating research programs with community physicians. So I broke off maybe four and a half years ago, I started doing this on my own. I think it’s really shocking when you get out and realize how many physicians really want to be involved, they just don’t know where to start. So providing that infrastructure and making it as easy as possible for them, we’re up to something like 90 physicians in our network just here in Oklahoma City. We’re working with a large hospital system and providing research infrastructure for them. So that’s kind of where we’re at today, and it’s just, we’re still relatively small, bootstrapped, and just trying to scale organically.

Joseph Kim:
Yeah, I mean, in the last sort of five years, ten years, maybe, you hear more sort of commercials from healthcare institutions. I don’t say bragging, but using research as kind of a differentiator, like come to this hospital because we do research. But contrasting that to your early days where people were shutting doors in your face like, I don’t want to do this, w, over what span of time did physicians change from like, I don’t understand this to like, gosh, I’ve always wanted to do this and how do I sign up?

Brad Hightower:
Honestly, you know, I don’t know that there was a shift in sentiment as much as, I think it needs to be appropriately sold to the physician, if that makes sense, I think it’s more in the approach that you take versus, because look, a lot of these guys, their only experience in doing clinical trials is maybe in residency or a fellowship or whatever medical school and it was, they had to deal with a local IRB, they maybe were just doing data dives and so they don’t, it’s still just kind of poorly understood. So I think with the right amount of education as well as, I hate to keep using the word selling because that feels a little bit dirty.

Joseph Kim:
Positioning, positioning.

Brad Hightower:
Positioning, right, positioning in a way to where it makes sense to them, I think is really the key. So I suspect that there was never a disdain or distaste to do clinical trials. It was just that it hadn’t been appropriately positioned to them in a way that made sense and made it easy. And then, of course, I will say that dealing with a large institution is a whole different ballgame than dealing with a small private practice physician.

Joseph Kim:
So then after, well, in academia, it was like a small neurology department, you didn’t do a lot of research there anyway. And now you’ve expanded into a whole bunch of different indications. Like, what sorts of things do you, indications do you research at your firm?

Brad Hightower:
Just about everything. I’d say one place we don’t touch a lot, we don’t do a lot of pediatric, but we’re pretty heavy in GI, cardiology, we have a couple of different derm practices. We’re just now getting in, landed our first four oncology trials, working with rheumatology, endocrinology, women’s health, you name it. You know, if it’s available for me as a site, I feel like the best strategy is to diversify therapeutic areas. We all know maybe cardiology is hot, well, once all the PCSK9 drugs were approved, there wasn’t a whole lot of trials anymore. So we’ve got to be somewhere else, we’re going to keep the doors open. So our mission is to really try to be as diverse as we possibly can.

Joseph Kim:
Yeah, these drug classes kind of come through the industry and through the community. And once those are done, like the interleukins are real hot now and once the ILS are gone, it’ll be something else for a different.

Brad Hightower:
What’s next, right?

Joseph Kim:
Yeah, therapeutic area for sure. So I’m going to start with a little old adage to transition us into the meat of the talk, which is, you know, be careful what you wish for, right? So and I say this jokingly, clearly, you’re passionate about research, but judging by a lot of your LinkedIn posts, there’s still a lot that can be improved. And gosh, I don’t even know where to begin. How about we talk about your last post, which was, hey, if you’re a male who’s never taken a drug before and so you list out this like hypothetical, very constraining set of eligibility criteria, but not all that off the mark in terms of what research is looking for in terms of a patient profile. They’re often looking for people who are left-handed and speak three languages and men who don’t ask for directions like that kind of a thing. It’s a very narrow, narrow eligibility set. Tell us more about where like, of course, there needs to be a balance because you just can’t, in the beginning, give it to all comers because you can’t distinguish signal from noise. But where do you see things getting, just come on, guys, why did you include these inclusion criteria like, where do you see the sort of the most egregious I&E criteria being set?

Brad Hightower:
I mean, and I think especially if you look at some of the responses there, it’s fairly pervasive that that’s the case. I mean, of course, the post was meant to be satirical, but it’s totally barely satirical, right? The example I use a lot is that we work with a headache clinic and we’re doing migraine trials. Well, they’re seeing nothing but hundreds of migraine patients all the time. If I’m working a migraine trial and I can’t enroll any patients out of this clinic, then what are we doing? Who are we serving with these trials? And a sort of personal pet peeve I have is that oftentimes, you know, these are phase three trials. These drugs meet, get approval, who are they prescribing them to? Are they only prescribing them to those tight, narrow criteria patients? Well, no, they’re not, they’re prescribing them to a much broader patient population. So my take is like, well, then why aren’t we testing it on the broader patient population? Why aren’t we testing on what real patients look like? And not to get further down a rabbit hole, but I also feel like the whole DCT movement could probably be less of a big deal if we just improved upon our IE criteria. Instead of having to reach across the country to find the patient, why can’t I find them in my backyard in a typical clinic with typical patients, you know what I mean? So that’s something that’s always bothered me. I don’t think it’s getting better, I think it could be potentially even getting worse, and I don’t know if that’s, getting conspiratorial, is that like a strategy by pharma to make sure that they don’t get the noise they don’t want, that they just are getting those patients they know that it’s very likely to work well on. Or is this truly driven by the scientific need to be that sort of narrow? And I mean, I’m not a scientist, I can’t answer that. So forgive me if I’ve.

Joseph Kim:
No, I mean, you’re a scientist for sure. You practice it, so that means you are. Yeah, I mean, I think it always depends on the drug. If there’s a certain safety issue, of course, you don’t want to hurt people in research. Yeah, your point is well taken, and I like this notion of like, why are we trying to enroll the whole state of Oklahoma when there’s plenty of patients here if you just change criteria B and C, you wouldn’t have an enrollment problem, because that has always been the plot of DCT is to try and enroll more and more faster. But it’s kind of like the lady who swallowed the fly, right? You swallow the spider to catch the fly and you keep like swallowing different things when, if you just, I don’t know why you swallowed the fly. It’s the kind of, it’s the whole punchline.

Brad Hightower:
Just the fly out instead, right?

Joseph Kim:
Yeah, exactly. Well, this is like the least of our problems, because once you say yes to a protocol, what is it you get from the sponsor company to say, okay, well, here are your instructions of how to run this? And how different is that from when you were pitched the protocol in the first place?

Brad Hightower:
Yeah. Well, again, to.

Joseph Kim:
Are they catfishing you?

Brad Hightower:
I mean, I wouldn’t go that far, but I will say it’s, I mean, we suffer from a lack of standardization in that process, right, because I may have to decide if a study is a good idea for us based off of the study title and a limited synopsis that may or may not even include a full inclusion or exclusion criteria, may not include the mechanism of action of drug. It may not include, it certainly doesn’t include, oftentimes the schedule of assessments, which is going to be what we’re asking the patient to deal with by being in the trial, so it happens all the time. You look at a synopsis and you’re like, oh, easy, this looks great. We’ve got thousands of patients, so we’re going to put in a number that’s high and maybe, yeah, okay, maybe we’ll cut it in half just so we don’t look like idiots later nonetheless. And then you get selected for the trial, they come on and do site selection. There’s really maybe not a lot of new information even at that time. You get awarded the trial and then it’s almost it’s like, here’s the full protocol. As a site, sometimes you feel like, okay, well, it’s too late, we’ve committed to doing this trial now. And I know that that’s not true, you know, if we don’t sign a contract, then we’re under no obligation to go on, but you’ve also already put in a lot of work. You’ve got some sunk costs kind of in this at that point, you know? The protocol doesn’t always tell the whole story, even in and of itself. So I can look at a schedule of assessments and see that I need to draw vital signs or, not draw vital signs, but I need to take vital signs. Well, what I didn’t know as I needed to do them three times, 5 minutes apart in different postural situations, and those sorts of things start to stack. They start to stack up throughout the course of you going through a protocol or building source documents, and then pretty soon you’re like, This is a huge pain in the ass, and we didn’t expect this, and this is way harder than it is, but we already committed to enrolling ten patients. Now the sponsor’s mad at us, but we’re trying as hard as we can. I mean, as you can see, this is a kind of a disorganized story, but things get away from me real quick. And it gets challenging to account for all of those things when a lot of that information is just simply not available to you at the time of, the time where it’s, you need to make the decision right now. Sponsors are, honest, oftentimes, you’re on a three-day, you know.

Joseph Kim:
Response time.

Brad Hightower:
We need this back immediately. Well, okay, then, here it is, and then we just have to say sorry later.

Joseph Kim:
Yeah, yeah, I mean, so this anecdote of the vital signs thing, right? So in a schedule of events that would be represented as an X under a visit with the vital signs, and then maybe there’s a footnote at the bottom or maybe in, later in the protocol, there’s appendix 1-3, where it starts to label all that out. And to your point, it’s just impossible in the heat of the battle to be flipping through and looking for stuff, even if it’s searchable. So let’s say you have like a searchable way to do it, like you’re still, …., yeah good god. You still have to remember what you don’t know, which I think is kind of one of the key things here. If there’s an unknown, unknown, well, then you’re out of luck at some point. And I guess maybe compounding the problem further, let me test this on you, because you’re running multiple protocols, you’re not seeing five patients for that protocol Monday through Friday, right? You might see patient for protocol A on a Monday and not see another one till the next Monday.

Brad Hightower:
Right, yeah, or a week, two weeks from now, just depending again on how difficult it is, and we do take, and a lot of sites try to take measures to minimize those unknowns. So we’ll say, very quickly, give us some CRF guidelines so that we can actually know what the hell we’re going to be looking at, because there’s nothing worse than having a patient on-site and you’re trying to maintain or write down your source, but then you’re checking it against the CRF in real-time, you’re drawing this patient’s visit out to several hours, possibly because you don’t want to mess up, and a lot of times, again, you just don’t know till it’s too late. Even with CRF guidelines, a lot of those are written as, almost like code that goes into the EDC. So you’re having to like translate this weird code out of this 200-page document that you’re going through, and it doesn’t always make clear what’s conditional that’s going to pop up once you enter something else in. So again, you really turn into like, your coordinator can turn into like a private investigator real quick and it’s gets challenging, it can be very overwhelming.

Joseph Kim:
Yeah, I mean, you should almost recruit from the police academy to get a bunch of detectives working under you, too. So as you’re, as you might get like a perfect, I don’t say perfect protocol, what’s the perfect kind of set of instructions recognizing that, because as soon as I say set, it’s imperfect because you don’t want a bunch of manuals, but like what’s the perfect set of instructions you might want to see from a sponsor to be able to do your job as a hardworking, smart person of integrity?

Brad Hightower:
Sure, and we’ve seen this with some sponsors. It’s very rare, but they’ll oftentimes provide a separate sort of manual of procedures, so that is, I mean, it’s chronological, right? So I can know going into a visit. Well, I need to start, this is another conversation, but like what system do I start with? Where do I get the subject number? You’re going to start with IBRs here, you’re going to get a subject number, it’s, is it going to carry over into the EDC or is it not going to carry over in the, to the EDC? I don’t know that yet, But again, having some even broad instructions or manual of operations to sort of lay these things out for you is incredibly useful. And I feel like if you’re the sponsor or CRO or whoever putting in all the time into these protocols and all these vendor, separate vendor manuals, like why can’t we consolidate that into a cohesive manual in some way? You know, again, it doesn’t have to be perfect, it doesn’t even need to be perfect. Honestly, just give me a starting point so that I’m not sort of grasping in the dark, especially for those first two or three patients. And again, we’ve seen this across some studies, And when it, when they do it, guess what? The study gets more attention because it’s easier to navigate. We waste less time, you know, trying to correct issues we didn’t even know existed, patient visits get done quicker because we’re not, again, we’re not in the middle of a visit going, well, what do we do next? Which system? Now, wait a minute, which system is it that kicks the drug out for us? So I feel like it would behoove sponsor and site alike to be more deliberate in providing these sorts of things. And I can’t account for why it’s not more prevalent, it just seems insane to me that it’s not.

Joseph Kim:
Yeah, it’s just a full integrated workflow of tech behaviors, data, like you said, it’s going to make things go faster, which is good for the site because your turn is better. It’s good for the patient, no one wants to sit around longer than they need to. It sounds like the data is going to be much higher quality because you’re just going to make less errors. This is, it’s just a win-win, win-win.

Brad Hightower:
Well, I mean, let me turn a question around on you. I mean, I’ve heard this from CRAs. I like to really pick the brains of the CRAs who come in just because they see so many different site models, but I understand that a lot of sites want to do things their own way, right? So there may be some pushback from sites in these situations because they’re saying, oh, we have our own SOPs and our own way of doing things, we don’t want to be beholden to a CRO or sponsor and what they’re telling us to do. Do you think in any way that could possibly prevent this being more ubiquitous? I mean, do you think that’s.

Joseph Kim:
I don’t, I mean, I think there are sites who want flexibility to do certain things their own way. I do believe that for sure. What doesn’t need, what is not mutually exclusive is to allow that, but then also provide tight orchestration around things that must be done a certain way because of the science as well as serve up all the right tech when you need it. So those things are not mutually exclusive, I think. So, if I can imagine just off the top of my head a workflow, there are going to be certain things where it doesn’t matter for the protocol that they’re done in a certain order or whatever, like those can be just set aside as, you do these however you want. But when it comes to the technology, here are the things you need to get in that order, or else it’s just not going to work. So I mean, it’s a design problem.

Brad Hightower:
I agree with that, I agree with that sentiment. Again, I think it’s hard sometimes, especially for academic sites and big institutions where we tend to look at things in a very black-and-white way and don’t always, I like to embrace the grey. I’m a big fan of that, but I don’t think that’s necessarily a common sentiment when it comes to clinical trials. Things need and want things to be almost excessively clear, and unfortunately, it’s just, that’s just not, that’s not how it works.

Joseph Kim:
Yeah, and to your point, like an integrated workflow can be presented and if you don’t want to use that, just throw it away and do it your own. So it’s not preventing the sponsor from building one, for people who want it, to your point. So in terms of percentage of studies that might come across your desk, how many today get a really good kind of integrated workflow presented, and how many are just like either manuals or worse, nothing?

Brad Hightower:
I mean, I want to say it’s sort of the Pareto principle 80/20, but it’s probably, that’s probably not accurate. It’s probably more 10% or providing something really actually useful and beneficial to sites. And I find the irony is that the bigger the sponsor company, it’s almost the less support that’s given, you know, which seems counterintuitive to me. But if I work with a small device company, a lot of times they’ve got, they got their ducks in a row, and I don’t know if that’s just because, I mean, they don’t have any other choice if their device doesn’t, if their drug or device doesn’t work, they’re screwed, they’re out of business. But, you know, a big company can afford maybe to string things along or not do that. But yeah, for whatever reason, it’s always occurred to me that like, oh, you’re the company that’s got the $20 billion dollar market cap, and you can’t provide me any resources. You’re not even going to send me a binder to put my rec documents in. So very strange, but that seems to be the world we live in.

Joseph Kim:
I think we should have a second podcast about, around finances because I’m dying to hear, we’ll do that maybe a second time. I do want to sort of end on a more positive note, which is like, why do you stay in research? It’s clearly a headache and this is a softball question, but like, why do you stay?

Brad Hightower:
I mean, I do love it legitimately, and I do worry that like my sort of public cynicism or skepticism is painting a bad picture. But, you know, we’re, we just finished enrolling a trial for patients with post-amputation pain. It’s a fancy stimulator that goes around the sciatic nerve, this is just an example. But being able to see, these patients are crying because they’re pain-free for the first time in their lives, and these are people who have been on the brink of suicide because of chronic pain. And to see people’s lives change and quality of lives change, I mean, it makes it worth it. I mean, it sounds cheesy and it sounds like sort of an easy answer, but I mean, it’s very visceral and emotional to see those things, and frankly, I mean, a lot of that’s what keeps me going. And then on top of it, I feel like in any way I can help contribute to the inefficiency to help get these things to market faster because these things need to be in people’s hands, you know? And whatever small part I can possibly have in that, I would feel honored to be able to be a part of that process.

Joseph Kim:
Yeah, now, on me, all your comments don’t land as cynical at all. What I see is another person who sees the emperor is not wearing exactly the clothes they think they’re wearing. And I think it’s really important for people to echo that, amplify that, agree, align, and make some change for sure. How about the physicians who have come onto your model? How are they liking? Is this everything that they wanted? Is it, has anything surprise them about the research enterprise?

Brad Hightower:
So yeah, it’s an interesting question. I think it’s, it spans the spectrum, right? Because frankly, I mean, we have physicians get into it for all kinds of different reasons. I mean, some for better or worse, they are interested in the financial, potential financial gain that they can have. Some are doing it for much more altruistic reasons. But I do think, and this is also why it’s hard for us to scale as a company is, it’s very personal. And I think we try our damnedest to sort of customize our offering and our approach in a way that resonates with that physician. And ultimately, I think that’s the key to success when it comes to increasing access to clinical trials. I mean, I think we have to do a good job of making it so that the physician likes it and whatever that may mean, whether that means they want to have their name in a newsletter as a leading enroller, or it means that they want to see some secondary income for their small, struggling private practice, or it means that they want to be a key opinion leader or whatever the case may be. So generally I will say it’s been overwhelmingly positive. Now I’m not going to lie, there are physicians out there that have no business being a PI and we come across those as well, sometimes too late, but I do think that it’s incumbent upon us to go out there and give it a shot, you know what I mean? And see who cuts the mustard and who doesn’t. And that’s sort of a long-winded answer without saying much. But again, I’d say overwhelmingly it’s a positive experience. And I think people, especially like some of these community oncology centers, deeply appreciate the ability to participate in these trials without having to reinvent the wheel and start from scratch.

Joseph Kim:
Yeah, yeah, so plug your research firm. Where is it? Where can people find you either online or in real life?

Brad Hightower:
Sure, I’m pretty active on LinkedIn. I don’t really use a lot of other social media, our research company is Hightower Clinical. HightowerClinical.com. Also, I do a podcast, NoteToFilePodcast.com, really geared towards sites specifically. And very lastly, I have a recent website ClinicalTrialConfidential.com, which is sort of a more of a web forum for people who can come together, even speak anonymously with the hopes that we can, again, sort of maybe come to some consensus and increase transparency at the site level so that sites can really all sort of rise together. So those are my plugs, I appreciate that opportunity.

Joseph Kim:
Yeah, I love it. Well, keep doing what you’re doing, Brad. I hope to meet you in real life very soon. Thanks for coming on the show and have a wonderful day.

Brad Hightower:
Absolutely, thanks so much.

Joseph Kim:
Thank you for tuning into Research Confidential. We hope you enjoyed today’s episode. For more information about us, show notes, transcripts, and resources, please visit ProofPilot.com. If you’d like to debunk a clinical research myth, share some more stories, or maybe just show our audience what kind of heroics it takes to pull off gold standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com. This show was presented by ProofPilot and is powered by Outcomes Rocket.

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