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In this episode, Maya meets Colin Sholes. Colin is the founder of Cure Clinical Inc., a US-based software company building a comprehensive database for clinical research performance analysis.
Maya and discuss the following topics:
(4:29) Why is a direct-to-consumer business similar to patient recruitment
(8:06) How to balance the pitch to patients with the site demands
(11:23) How to achieve consistency in patient recruitment ads
(14:40) Are sponsors and CROs reacting to clinical sites direct feedback
(16:58) How does Cure Clinical make trials more scalable
(20:50) Do sites need better statistics or better tools
(24:00) The #1 solution to make trials more patient-friendly
Tune in today for a thrilling journey into the world of clinical trials – expand your knowledge!
Maya Zlatanova, CEO of Trialhub
Colin Sholes, Founder of Cure Clinical
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What is Trials with Maya Z?
90% of clinical trials fail, 85% get delayed. Let’s deep dive into the world of planning and running of clinical trials with some of the most experienced and passionate people from the Industry and find out what makes trials more successful or more challenging. Welcome to Trials with Maya Z podcast!
Maya Zlatanova, CEO of TrialHub: https://www.linkedin.com/in/mayazlatanova/
Hello everyone. And welcome to Trials with Maya Z. I'm today with a new friend of mine, Colin, the CEO of Cure Clinical, another CEO fighting for more involvement of sites, also patients coming from a very interesting background and with very interesting perspectives. Colin, can you tell us a little bit more about your background and what brought you to clinical research?
Sure, thanks. And it's good to be here. So my background is primarily entrepreneurial. So for many years, I was running e-commerce and direct-to-consumer companies. For a while, I had a software company for credit card payments. And then, um, around 2012 2013, I got into doing advertising and marketing in the insurance industry, which was Interesting.
And it exposed me to how to do direct advertising, um, Facebook, Google, that sort of thing. And when I exited that industry, a friend of mine ran a clinical site out in California. And he was struggling to scale up his patient recruitment. So I offered my services, as a consultant. And, now, you know, I manage all of his patient recruitment and marketing, and, I have a couple of other clients as well.
I've worked with a few different clinical sites, sort of at what we would call the top of the funnel of patient recruitment, so that'd be running Facebook ads, Google ads, email, and SMS outreach, and that sort of thing basically to find patients for studies and then hand them off to the clinical staff's recruitment team to try to get them into randomization or try to get them into a study.
The idea for Cure Clinical came about because a friend of mine had built a tool that he used to help his site find more trials. So he was taking publicly available research data on all the research payments made to US PIs and sites. He was comparing his site to other sites in various studies and then using that to negotiate with sponsors to try to get his at the time new site into more trials. And he eventually stopped maintaining that database because it became too unwieldy. And he suggested to me that there was an opportunity to build a company around taking this publicly available data, matching it up to the study data from clinicaltrials. gov, and then using the resulting database as a tool to help sites help CROs and sponsors, and basically to provide a variety of services to various points in the clinical trial continuum for companies that are just looking for more information on what the clinical trial landscape even looks like. Because for many years it's been a real mystery to everybody involved, yeah. Different companies and different people in the processes have small windows into how their part of the trial ecosystem works, but they can't see the big picture, right? So that's what we're trying to do, you know. For sites and everybody else, along the chain up the ladder or whatever metaphor you, choose there.
Yeah, I love that you're coming from a very practical need and for something that you were trying to do some like manually, but then, um, how can we use spec? And usually, these are the best cases where you can, where you create solutions. But they're enabled by tech but actually inspired by real need, practical need.
So that's very interesting. And I definitely want to learn more, but before that, I couldn't help but notice that you're the second person on my podcast speaking about using the direct-to-consumer experience and background, um, and apply it towards patient recruitment and inviting more patients to clinical trials, like bring them, bring more patients to clinical trials.
I wonder, have you thought of which are these common things between your past businesses, direct-to-consumer businesses and what you've been doing on patient recruitment? What are these common things, but also what are the differences? Have you thought about it?
Yeah. So, I think advertising is sort of a dirty word to the average person, they want to believe they do have free will and that the products that they're buying or the services that things that they're clicking on on the Internet are entirely of their own volition and they're not being manipulated in any way. And there are plenty of advertisements out there that manipulate you. But that said, they do work, right? Advertisements work and they exist for a reason. It's a massive industry for a reason, which is that for some small percentage of people who are not aware of a service or a product or whatever it is seeing an advertisement or seeing it repeatedly can be really helpful for them, right?
Like they may become aware of a service that they didn't know existed or a product that they didn't know existed. you know, I'm certainly not trying to apologize for the advertising industry because, again, there are lots of bad actors there. And a lot of it is very superfluous, but.
Yeah. As far as patient recruitment, at least from my understanding, talking to people for the last few years in the industry, that is still the big hurdle that any study faces, right? It's like getting the right people into your study and the way that myself and some others at different sites and, you know, people I've met around the industry that use direct advertising to do patient recruitment, We can put that messaging in front of people and, and it is very useful for kind of narrowing down your audience to find the
people that have a specific need that could potentially be filled by a clinical study because, anybody that's been to all these sites that are set up to educate the public on what clinical trials are going on can tell you they're a mess, right?
Clinical trials. gov, even with the rebrand is very difficult to navigate if you're not a researcher. So there's just not a lot of information out there about where the average person can join a trial. I mean, there are lots of really great efforts with working with GPs and doctors and hospital groups and stuff like that to get these people who have existing conditions into trials that would suit them. And that's fantastic. But what about the rest of the people? Right? What about the people who aren't going to the doctor for a particular need? So, you know, in the case of the main trials that I've done recruitment for Alzheimer's, there's a huge percentage of the populace who are concerned about memory loss as they get older, because it's just a natural part of getting
older, right?
It's, hard to distinguish whether, you know, being forgetful in your 60s is a sign of cognitive decline, or whether it's just
Yeah. Mm.
know, for those sorts of people who haven't been diagnosed with anything, but still have those concerns, putting ads in front of them to say, listen, you know, you can get screened to see if you have any, if you're at risk for these sorts of things, and if you are, there might be a clinical research trials that you could join, it's a relatively straightforward pitch to, at least to me, as someone who does advertising.
Right? So, and the same thing applies for weight loss, cardiovascular, cardiovascular type things, for people who are concerned about health issues, but aren't actively in some kind of pipeline, you know, with their doctor or with a hospital,
you know, advertising, I think could be a very powerful tool for patient recruitment and one that if it's done responsibly, when
everything's getting approved by IRBs and all that, it should be, you should be using language that's approved by sponsors and all that stuff. it can just be, it can be very effective for sites to reach populations that they would normally not be able to interact with, right?
Mm
Colin. Actually, the question that I have while listening to you is, is it really effective? And actually, is it effective from like, which eyes, like which point of view? Because when you mentioned this relatively easy pitch to the patients, I understand exactly what you mean, because in the past I've been also running global patient recruitment campaigns.
But I also know that this pitch is exactly what sites hate. At least that's my experience. But you actually work directly with the site. So I wonder, how do you balance the, let's say, the basic pitch, hey, you may have this, you may not have this, but better go, come and, like, get more information at the site with the site saying, we want to actually meet only the eligible patients.
Yeah. That's, that's been a balancing act, right? You, the recruitment team don't wanna waste their time with people who are coming in for every, imagined concern or people who are hypochondriacs not to denigrate people that are concerned about their health. So I think the balance is that you need to be very explicit in the advertising and craft it with the site's recruitment team and the raters and all the people that actually have to deal with the patients to say, okay, we want to make sure that people are very aware of what they're walking into when they walk into our clinical site.
We're like, this is, we are recruiting patients for research. You need to state that very clearly during the screening process. So, At least for some of the trials. At the sites that I work with, there is a phone screening process. So the recruitment team calls someone up, they have a script, they walk them through that and making sure that that script matches what they're seeing in the ad. So again, people aren't confused, right? You want to be very explicit in your advertising that it is for clinical research, that there may be by-product benefits from it, but yeah, just saying like. You know, are you worried about your memory? Well, come into this clinical office and we can help you with that is way too vague, right?
Like, and. And so you need to tailor your message to be, conscientious and to make sure you're informing, patients of what they're getting into and, and the recruitment team giving feedback, you know, any good marketing department at any site or any network of sites or CRO, et cetera, should be working very closely with the recruitment team to say, what are you hearing from patients?
Are there any problem areas? You know, are people saying that they. Okay. Okay. Don't remember clicking on this ad or the ad. They thought the ad was for something else. And yeah, just, you know, it's just an iterative process where you communicate regularly with the recruitment team to make sure you're not making their lives more difficult. And also again, to make sure that the patient experience has continuity from end to end. So the messaging is the same, they're never confused about what they're signing up for or what they're submitting their information to receive. Right. So honestly, that's just the best approach to advertising more generally.
Like I think, you know, short-sighted folks in any kind of business would say if I just want to get as many people in the door as I can, even if I'm not being clear about what my product or my services and its like, yeah, but then you're just wasting everybody's time, right?
The customer's unhappy. You're unhappy. You're wasting your ad dollars. Especially in clinical research, because it's such an important, process and it's such a particular process. But, I certainly wouldn't recommend, in any way, misleading because it's just, it just creates a bad experience for everyone.
Yeah, but at the same time, like, I 100 percent agree with you that we need consistency in the messaging. Not just messaging. Every single step of the patient. For them it's one journey, right? From getting the ad, like seeing the ad, to let's say getting the appointment with the site, meeting the site personnel, going through the screening, hopefully enrollment, then being a part of the clinical trial, completing the trial.
This is A whole journey. and at the same time, there are different stakeholders in charge of these different steps of the journey. So I've never seen so far a patient recruitment, let's say company, agency, whatever you call it, being also involved in the way the consent form is being created, for example.
So how can you achieve this consistency? Is it even possible? Like I'm really thinking loud here.
Yeah. I think that my friend's site is where I, I work pretty closely with the team. Yeah, you're right. I'm not involved in that, that backend process. But I think, a well-run site is going to put all those stakeholders at the table and say, okay, you know, at least with my friend's site and with other sites I've worked at, we try to be very data-driven, in the sense, not reducing patients to a bunch of numbers on a page because, again, you can't do that. Every patient is very different and has different,
you know, needs and challenges, but to say, if there's a point in the enrollment process where we're having a lot of people drop off, right? We look for, you know, if a bunch of people are saying they're not interested in a study and they were when they walked into the office. What's happening in that process, right? And then engaging with all those various stakeholders at a site level, to say, okay, did the raters say something? Or is it, as you said, the consent form? Is there a problem in the consenting process? Is there a problem with the logistics? You know, Running Alzheimer's trials for a long time has been very challenging because You need not just 1 person, but a study partner to come to all their appointments with them.
And that's a huge ask, right? Like that's you're
really asking not only 1 person, but their loved 1 or their spouse or whoever to make this really serious time commitment. So, speaking more broadly, I think sponsors are gradually at least from what I've seen, with the recent success of some of the Alzheimer's trials, starting to be more mindful of just how much they're asking of patients to even participate in the study and, and trying to tailor, trying to work on their study parameters, and be a little bit more responsive or, engage a little bit more with sites.
Now that I'm way on the other side of operations, I could be completely off base with that, but, you know, I, I think we're seeing more studies that are a little easier to enroll, hopefully, because sponsors are learning from, how challenging it's been in the past.
So what's your observation? Like, do you have any observations in general, how much sponsors and clinical research organizations are listening to the sites and their direct feedback from interaction with patients, and their staff? Yeah.
Well, I had, I had an interesting conversation going to the SCOPE conference was interesting because I got to talk to some people on the other side who are normally completely removed from my existence. Um, I spoke to one woman who works at a sponsor and she had been on the Alzheimer's side, on an Alzheimer's trial and then got moved over to weight loss and she said, it is a dramatic change in how I interact with sites or sites that want to be in my trials because when I was on the Alzheimer's side, I knew my good sites and I was like clinging to them for dear life, right? Because you're like, you're my good sites. Please don't leave. You know, we'll help you with the things that you need. And she said, with the weight loss trials, because they're so competitive and everybody wants into them because they're functionally healthy patient trials, and they're going to recruit like crazy.
She's like, I'm turning people away. You know, I suddenly have this almost adversarial relationship with the sites and I think that's. That's a problem. There are a lot of sites out there. There are tens of thousands of sites just in the U S and well, 15, 16, 000 sites in the U S and they're all going to be competing for the tastiest trial.
But I mean, I think sponsor relationships can be very situational in the sense that at least my impression is that, sometimes like Pharma reps would come to. To my friend's site and say, well, how can we help? What can we do to make this easier for you?
What can we do to make this better? And in other trials, they're completely removed from the process. They're like, you're replaceable, right? You're commodified. And some of these, with vaccines, with a lot of these new trials that are going to be very high enrolling, very quickly enrolling. That relationship is, probably. Yeah. A lot different from the ones for these specialty sites that have become very good at doing certain things and doing certain indications, doing certain TAs. So that, to me is like, I mean, it's a problem, but it's understandable, right?
Like that's how business works, unfortunately. And, despite the good that we're doing, you know, it's still business to an extent, that it's for-profit and these companies have to make money somehow.
And also, to your point, every single clinical trial is different. Uh, so, I understand that also the sites are different. Like, there are some professional sites and others are that's a part of other things they're doing. So, it requires different types of relationships and different types of dynamics.
But at the same time, I can see the need for more scalable ways to interact and build relationships for the sake of more efficient clinical trials. And I wonder where Cure Clinical fits into the whole ecosystem. What is the main gap that you're trying to, fill in?
So what we're trying to do is address problems of opacity or, you know, or lack of transparency all along the chain, all along
the ecosystem. so from a site level, we use our data to help sites, professional sites that are trying to grow or trying to better, do business development, trying to get
into these are trying to even understand, like, where they are on the pecking order in the studies that they're in.
So, you know, right now, a site may not be aware. I mean, some sponsors send out progress reports and they'll give you leaderboards or anything like that. And some sponsors will be transparent about how they are recruiting compared to their peers. But that's just sort of a number, right? You don't really get the bigger picture of how a study is progressing and what your part in that larger ecosystem is. So at a site level, having access to data on how the study recruited or how the, you know, from a payments perspective, like who the sponsor paid the most money to where you were in that order, can be very useful and also to see other sites that are in your same competitive environment, sort of your peers, right?
Like, you know, whether you're a small site, a large site. Who are the people that are doing the studies that you're doing? How are they doing them? What other studies are they in? So you get that kind of viewpoint. And from a higher level, so we work with site networks who are looking to either do MNA or do de novo,
open new location. Or just assess their existing, uh, study mix to determine whether maybe their sites are underperforming in certain therapeutics and they shouldn't be in those therapeutics. Or maybe they need to address those therapeutics and why they're underperforming. so site networks and, financially owned sites, can. Gauge their activity and performance that way. And then at a CRO and a sponsor level, I mean, site feasibility and site selection is it's a big,
you know, big industry. And I think, our focus is primarily for maybe smaller to midsize CROs and sponsors, who aren't already working with every single, source out there and all the big software sources and software providers and IRBs, to say, to give them a look again at the, not one specific study or one specific set Of recruitment data, but just the whole landscape, like a directional look to say, okay, well, what's happening in the entire therapeutic of neurology, last year, like, how did that look?
Where were the sponsor's money? Which sites were they working with? Who owns those sites? Are they, working with academics? Are they working with private sites? So that's all of those things kind of combined we're not limiting the people that we want to help to 1 particular industry, and I, and I'm highly sympathetic to site owners and site operations people because that's who I've worked with for the last few years.
And I've made many great friends and
You know, there are challenges inside out.
Totally so, I'll always be on on the side of the site folks in terms of just. They have far fewer resources and they face a lot of challenges.
I think that's sort of where this started and, if there are other industries and other, or other parts of the industry that can find our data useful, then, we're happy to try to empower them.
Yeah, but Colin, you mentioned that you'll be always on the side of the sites. and one thing I know from my experience in the industry is that sites have way more tools and like things that they have to use. But if I understand correctly, though, that they do have a lot of tools.
But they don't have tools that help them understand and orientate themselves where they are and let's say the research progress. Do you think that, like, were they asking for that and sponsors didn't deliver or was it something like that they just realized recently that they need better statistics on how well they're doing compared to others?
It's hard to say because my sample size is primarily of people who are taking site their professional sites. I guess you'd call them,
where they're taking, they're, they're trying to take a more focused approach, and treat it more like a business, rather than, some of the ways that the industry's progressed in the past. But I think, it's yeah very difficult to interface with one sponsor for one study and get everything you need from that sponsor that's not to say that that's the sponsor's fault, but that's whoever your coordinator is, or whoever you work with at a particular sponsor has many other people that they need to provide support and services to as well.
Right? Or the CRO has a lot of people that it needs to provide support to. So I think it's just a lot to ask for. You're running. Mm hmm. 10, 12, 15 studies that you're going to get, you're going to have the time and the, and the energy and the resources to work with each one of those sponsors, or, even if it's four or five, six sponsors. To get all that information, right? Like to say, okay, well, I need all this documentation. I need constant updates on how I'm performing. And that's also just an awkward conversation, right? Like you don't necessarily want to ask a sponsor, like, well, am I doing well in this study? Because the answer might not be one you want to hear.
And, the sponsor relationships for sites can be so important to their literal existence that I'm sure they don't want to jeopardize that, right?
Oh, yeah. I understand what you're saying. But at the same time, honestly, I would challenge that, at the end of the day, you said it correctly. It's a business relationship in every managerial book, like you would read that you need to be transparent on the performance of like, of your, let's say, team, making sure that they know how well or not well they're doing, because, if you don't do that, then you can't expect better results. It's not about criticizing, it's more about promoting, let's say, transparency. And at the end of the day, I don't think that, especially nowadays, I don't think that there is any sponsor out there that actually wants to work with the low-performance sites, of course, with the exceptions of the key opinion leaders, but even then more and more pharma companies are realizing how important it is to actually emphasize on the
well-performing sites. And sometimes better performance comes with better feedback. So I understand what you're saying that sometimes can be sensitive information. But at the same time, it's critical if you want to see better performance. Colin, because we're running out of time. I do have one last question.
It's a question that I ask every single one of my guests. What do you think is the number one thing that will make clinical trials more efficient and patient-friendly?
Oh, man,
Your perspective. Yeah, right. I'm looking for your perspective, not what's really right or wrong. There is no right or wrong. It's about what, how do you feel things?
The challenges that I see - in my work at the recruitment level, right? -are that study design can still be very difficult to navigate at a site level, like inclusion-exclusion criteria can be real challenging. And I think that, especially in Alzheimer's, which is, again, my area of expertise.
You have studies with crazy failure rates, because they have these strict screening criteria, and, to me, like, listen, I, I understand that they're solving for a very specific kind of issue
and it needs to be designed very carefully and cautiously because there's lots of money and time involved and they want to make sure they get the desired outcome. But I think, when you have a large percentage of studies in a particular therapeutic, that's a very important therapeutic, neurology, and not that they're all important. Sorry. But, when you have a lot of studies with a very high failure rate. But you're also encouraging sites to recruit from this particular population.
You know, you're saying you want people over a certain age with these certain criteria, but then you're running them through a bunch of different pet scans and all these other things and saying, well, okay, 98 percent of those people don't qualify for the very specific thing that we want. I think there needs to be some consideration for the people who have to go through all those procedures just to be told, well, sorry, we can't help you.
Right. So I think
I think there, there needs to be a bit more, and I know I'm not certainly not the first person to say this, but I feel like looking at it from a patient recruitment perspective, we get a lot of people who are very eager and excited to be involved in clinical research. And then, unfortunately, a lot of them get told, sorry, like, you don't, you know, you're not in this tiny little box that we need, in order to move forward. So,
I'm hopeful that sponsors will get better with this, but that to me seems like the biggest stumbling block right now in terms of getting people into trials and progressing medicine,
Thank you, Colin. I really appreciate your perspective. Thank you so much for taking the time to, share your insights. Good luck with Cure Clinical and, hopefully, we'll hear more about your progress, your results, and I'm pretty sure that you also motivated a lot of other people to see these challenges from a different perspective.
Thank you once again for joining me.
great. Thanks so much. It was a pleasure.
Hope you enjoyed listening to Trials with Mya Z. If you're interested to hear more about how clinical trials can serve patients globally, subscribe to the podcast on Spotify, Apple Podcasts, and Google Podcasts. Have a great day.