Webinar: Tech-Enabled Dermatology Clinical Trials — Delivering Faster, Higher Quality Trials for Sponsors

Simon Burns: Hello. Welcome to our webinar today . Thrilled to host you all for a conversation about technology enabled trials. Let me share my screen and introduce our team today. Today we have our Medical Director, Dr. Janet DuBois and our VP of Dermatology Betsy Zbyszynski. To talk about technology enabled dermatology clinical trials and the path towards delivering faster, higher quality trials for sponsors. Dr. DuBois, please introduce yourself and I’ll be back on in just a moment. 

Dr. Janet DuBois: Hi everybody. My name is Janet DuBois. I am a Dermatologist. I practiced in Austin, Texas for 28 plus years. And part of that time I’ve been in clinical research, running phase one through four clinical research study site. I am now the Medical Director of the Vial Dermatology CRO. And it’s nice to have you all join us for today’s webinar and then I’ll turn it over to Betsey.

Betsey Zbyszynski: Hi everybody. Betsey Zbyszynski. I head our dermatology division here at Vial. I oversee our dermatology studies and help provide strategic and operational guidance to the team I’ve been in industry almost 25 years. And the bulk of that at dermatology focused CRO. So I’m psyched to talk to you guys today and to meet with our team. 

Simon Burns: Thanks. And just quick context on myself. I’m one of the co-founders of Vial and very passionate about our mission to reimagine clinical trials, alongside a phenomenal team with Betsey, and Janet, and the rest of the team. 

To quickly describe Vial, like I mentioned, we were founded with a mission to reimagine clinical trials for sponsors and delivering faster. Higher quality trials.

Our approach to do that is quite simple. First we build a network of sites, clinics, made up of leading investigators who are partnered with us. We’ve now built a network in dermatology of over 30 leading investigators. And second we build and deploy technology that helps run trials, everything from site startup through to final data capture and submission.

And we’ll talk a little bit today about some of our approaches, but really hosting conversation about technology core to our approach in how we’ve come to market as a CRO, is to marry phenomenal team of clinical operations and CRO leaders with a team of technologists who come from engineering product and design.

And we firmly believe that it’s only about marrying the skillset and understanding of clinical research, knowing indications, knowing specific therapeutic area of expertise and, indication level expertise, as well as having the systems and resources to build technology that empowers that team that you can really reimagine how trials are run.

So with that, let’s jump into our first question for the panelists. Advice for biotech ClinOps teams. We speak to a lot of these at Vial, And many of them want advice on how to design their protocol specifically how to run a successful trial in dermatology. I’ll start with you Dr. DuBois. What advice do you have for biotech, local operations team who would come to kind of a general company who would’ve advice on how to design a protocol?

Dr. Janet DuBois: I think that’s a really good question. Designing protocols can be a little difficult and it can be very complicated and I don’t think anybody should feel like they should know how to start with their own protocol. Like they’re reinventing the wheel. So I would say, look at studies that have already been performed, especially with medications that have come to market.

So you can get an idea of what those study designs look like. And then you can also get an idea of what the FDA might be looking for and wanting to see in a study. Keep it simple. Make sure you have a good understanding of all the endpoints that you’re studying. Consider your inclusion, exclusion criteria without making things prohibitively cumbersome.

And I would also recommend seeking feedback from folks in the field. I think I’ve had people come to me asking about my opinion about a, protocol. I’m sure Betsy has as well. So those would be kind of the major points that I would make. And I’ll see what Betsy has to say. 

Betsey Zbyszynski: Well, I will jump on the Janet bandwagon. I definitely look, what’s been done out there. We used to pull the summary basis of approval, which is the approval documents on. You can get that on the FDA website for drugs that are already approved and see how their studies were run. At [00:05:00] least you have an idea of what FDA is looking for and what they most likely will accept in your protocol.

Again, as Janet mentioned, seek some advice from key opinion leaders, folks that have run many studies in that indication out there. We do that a lot. We reach out to a lot of folks from our SAB that are pretty well known in certain dermatology indications. And then yes, keep it simple, specifically for your primary and secondary endpoints.

If it’s an early phase protocol, you can certainly include exploratory endpoints. If you wanna learn additional information about your product, maybe pain exploratory endpoint or itch is big in dermatology, but for the primary and secondary in order to achieve success, you keep it as simple as possible. So you can hopefully meet that primary endpoint.

Simon Burns: Well said, I wanna move along to our second question for the panelists, which are what are the key challenges running trials? Both of you have run and operate countless trials in, dermatology. Curious, maybe start from the site perspective with you, Dr. DuBois and then move to the CRO perspective with you Betsy. In running dermatology trials, what are the common challenges that you see, and to go back to those biotech clinical operations teams, as they think about their trial, what are some of the challenges that they can anticipate and, get ahead of?

Dr. Janet DuBois: I think that, in our experience at the site level, there are always potential pitfalls when the protocol and the procedure manuals and the EDC don’t line up, or if there’s a, certain requirement tucked away in a very obscure part of a protocol.

For example, you have your inclusion exclusion criteria, and there’s nothing mentioned there about exclusionary electrocardiograms, and then you go to the EKG section and there you have it, the excluded ECGs. So looking at a protocol with all the other accompanying manuals and information and trying to make sure there aren’t potential pitfalls in this in the design that could be lost, could be encountered at a site. So that’s one thing we spend a lot of time on at our site ,is to carefully design if we’re allowed to design the source document so that we make sure we include any possible protocol requirement. The other thing that I think a lot of sites will echo is that staffing is a big challenge.

 You have to have enough staff for the big complicated studies, but not so many staff that people are sitting around with nothing to do. You have to make sure that you delegate to the appropriately trained individuals. You have to make sure that you’re coordinators treat their studies as if they’re their own babies and they put their hearts and souls into it.

And it’s very difficult to find people who are willing to have such a vested interest in a trial going on at your site. So there’s always a constant attention to making sure that staff is trained and feels respected and valued, but also that they can come to the PI and the site director with questions, concerns, and certainly any mistakes.

We really wanna make sure there’s total transparency because in the field of clinical research, as we all know it’s one thing to make a mistake. It’s another thing to not let the sponsor and the IRB know. And so we encourage openness and honesty and all of you out there in the field will know that those individuals are hard to come by. And once you find them, you really wanna hold onto them. For Betsy, she’ll take over the part about the challenges for CROs. 

Betsey Zbyszynski: Yeah. Thanks Janet. I love the part about having enough staff and quality staff, because a lot of, clinical research is humans entering data, humans recording data, transcribing data and errors are gonna happen. So we just need to make sure we acknowledge them and resolve and communicate them. 

 From the CRO side, the biggest challenge, I’m sure anybody from CRO that’s on this webinar will say recruitment and especially of late. Maybe in the past seven plus years, patients are so much more educated about their disease state. They’re educated about what medications are out there. What maybe they’ve [00:10:00] tried, what’s worked for them, what hasn’t worked for them. So even enrolling patients that might be naive to a drug or a type of investigational drug is really hard. And really supplying them with enough information so they can feel comfortable about enrolling in this study. If it’s something new, people will read up a lot more on the investigational product, or maybe something that has worked for them before. So I’ve really found that does make it a little more challenging to enroll patients. 

I think the other biggest challenge for CROs is study startup. It’s always a long process. If you have, you know, specifically, obviously multiple sites studies, if we have 20 sites in a study, getting them all up and running can take three to four months where you might have some starting in the first month, but by the time you get that 20th site up and running, it’s already four months in and the enrollment of the first few study sites that already started, they could already have met that. I ran a trial once, with molluscum, which is pretty prevalent out there. And I think we had 25 sites in the study. And again, we estimated about a four month startup. We tried to get the sites up and running as quickly as we can, but people go on vacation, getting documents back. So it was a rolling startup, but some of those early sites that started up, ended up enrolling the whole study. So by the fourth month, some of the later sites, were upset because they had committed to us, but then we were like, oh, sorry, it’s already enrolled. I mean, secretly we were psyched because as a CRO, we love completing enrollment, but yeah so that’s always challenging getting all the sites up as quickly as possible. 

Simon Burns: Here at Vial, we spend a lot of time with our inhouse engineering team, working closely with project managers and CRAs, both our own internal team, but also working closely with external teams in order to build intuitive software to help improve their workflows.

In particular, our in-house eClinical platform that encompasses EDC resource and, the core workflows. It’s helped us reduce site startup considerably in, in the process, I wanna highlight a couple things that our platform is able to do. 

So like we were saying, a big focus has been building intuitive software working closely with, the team. Now, what that means is our team of engineers, product and designers, sits down every day with our project management team, with our CRAs, with our bio statisticians and with the sites and our trials, is building the systems in a regular kind of sync with, these teams, the technology we built starts at the site level.

This is what it looks like from a site perspective to use our, eSource platform. As opposed to traditional eSource platforms that many people are aware of. This is intuitive. It’s easy to use. It actually reduces the time spent in a visit. There’s automatic data validation to ensure that information is entered correctly and raises errors if it’s not entered correctly.

And it’s able to reduce the time in a visit by being intelligent about the questions that are asked as well as filling in any, information that needs to be filled in by simply typing in it, auto fills a lot of the information. Now from a CRA perspective reviewing a source data verification and keeping track of your sites is, made much easier.

We like to say it gives our, CRAs superpowers. And so from this platform a CRA can see all of their, visits at the sites that they’re overseeing. They can dig into the individual visit forums. Dig into the information, you can see here on the right we’re digging into vitals. And if we wanna raise a query, it’s one click, I can raise query.

Now Betsy mentioned the importance of recruiting. We spend a lot of time with our engineers building recruiting systems. There’s a two-pronged approach that we take to improving recruitment. First is using many channels to drive involvement. And so whether it’s direct mail or radio, sometimes for mollescum trials, one of those works and sometimes it doesn’t, or it’s digital and other channels we’ll do Facebook, Google, Nextdoor, Craigslist, other channels .What’s important is that we’ve tried different channels on different trials.

We’ve now run over 750 trials in our site network. We have repeatable playbooks that work, but it’s not just about the ads. Once the ad goes out, it’s really important. The subject is able to go to a website, fill out the information. And after that’s really where the critical component is, we’re able to do an automated review of inclusion, exclusion criteria through their online form submission.

And then our prescreen call team will get in touch with them. This is the first prong. The second prong [00:15:00] is our EMR integrations. Now a few weeks ago, we announced integration with ModMed (Modernizing Medicine). We also announced integration with Nextech. We now have integrations with over 90% of the leading EMRs, including the leading electronic medical records in dermatology. So we’re very proud to be a part of the, ModMed platform as well as the Nextech platform. And what this means is we’re able to pull information, pull data out of the EMR. Then one click. The second set is greenlit for enrollment, pulling out the information, finding patients who are a fit, reaching out on their behalf, if they want us to and scheduling their visit for a clinical trial.

Here’s a quick screenshot of that team. So we’ve a team across the United States. All come from healthcare backgrounds, incredibly talented team that’s reaching out on behalf of the sites. They’re able to review patients, our workflow highlights to them if a patient’s a good fit or not based on exclusion criteria, we’re able to be hands on and see them all the way through their first visit and on through the rest of the trial, all in those those channels.

I mentioned those recruiting channels, as well as the technology implementation has been quite successful. Now that’s our approach to how to use technology, but let’s zoom out. Panelists would love to hear your thoughts on the opportunity for technology enabled trials. Technology’s been talked about a lot for what it could do for clinical trials, but from your perspective, where should it be applied to drive the most impact?

 We’d love to hear your opinion, Betsy on where you think technology has the most promising clinical trials. 

Betsey Zbyszynski: Recruitment for sure. I love our Vial Connect, getting into the EMR systems. Not only does it identify patients really quickly but it also takes a lot of burden off the sites. So that’s really, helpful to them. It’s very time consuming for sites. I’m sure Janet can attest to this, to go through their database, filter out which patients may qualify and then calling them. Scheduling them it’s very time consuming for the coordinators. So that’s a huge area I think that will really help impact clinical trials.

Dr. Janet DuBois: I agree 100% Betsy. I think we all agree that we’re never going to replace the people, number one. We’re not gonna replace the subjects with tech. We’re not gonna replace all of the staff working on the clinical trials with tech, we’re not gonna replace the CRO with tech.

What we need to look at is how tech can help the humans and I think all of us who have carried out studies know that whenever people are involved, as Betsy said earlier, there’s human error. There’s just no way around it. And if we have tech to minimize human error, I think that’s where I see the biggest gain. For example, when we’re enrolling subjects and we’ve done our, telephone pre-screening and then the subject comes in. There are humans who have already done the step of deciding whether this is a potential candidate. And then you gather all the information that you need. And in most places it’s still done at most sites on paper.

And then by the time you’ve had the patient or the subject leave the office, you go into EDC to enter things. And that’s when you find out, whoops, this person is on an exclusionary medication or this person’s out of the age range. A type of tech enabled system that would give you alerts, say, as you’re entering into the eSource, the subject’s age. And it says, you know, the age is 46, but we’re only supposed to enroll folks from 18 to 45. Or somebody’s on a medication that happens to be metabolized down the cytochrome P450 pathway. And it’s, excluded . The technology could alert you that you better stop there because this person should not be entered.

And I think it can also help with alerting us to potential deviations potential pro exclusionary, or study stopping lab values, or electrocardiograms. Right now we rely on multiple humans to bring it to our attention and then ultimately rely on the very Imperfect human PI to find anything that everybody else has missed whereas I think technology could really help in that regard. So that’s where I think the eSource idea could be a tremendous help to those of us at the site level. 

Betsey Zbyszynski: Yeah. Agree. And whenever any of us go to any doctor’s visits now, the PA or whoever you see first that maybe takes your vitals, the med tech, they’re entering everything right away on a tablet, sometimes, maybe a laptop.

So that’s really very similar to eSource. The med tech or the [00:20:00] coordinator or the PA who’s screening the patient, they have their tablet, or maybe they’re walking around with their laptop and they’re doing inclusion exclusion. And there’s a red flag, saying no to this. They cannot go further. So that would be huge. Decreased screen fill rates, which of course decreases costs. It just goes on. 

Dr. Janet DuBois: Yeah. And, you know Betsy, I’m old enough to remember when we had to switch from paper charts to electronic medical records. And boy, I was one of the ones who complained the most, because I was so used to my paper. And then I had to learn electronic medical records and finally got to the point thatI loved electronic medical records. And then when the internet was down and we had to go to paper, I just hated paper. So I think those of us who have been doing clinical trials for a long time and are kind of stuck on paper, we’ll get used to eSource easily. And then we’ll, realize how did we ever function without it is basically, I think what’s gonna happen. 

Betsey Zbyszynski: Yeah. I mean, I’m not gonna say my age, but I do remember paper CRFs. And then going to EDC. So that was a huge deal. And now, it’s unheard of- paper CRFs.

Simon Burns: Well, wanna open it up to questions and answers from the audience here. It was great hearing you both talk about eSource and I think Betsey your analogy from the clinical component of a practice and the research component is exactly spot on.

 It’s remarkable how often we visit a site and we -ask what’s going on what systems they use for their clinical. They’ve got all the fancy technology, they might have modernizing medicine, they have another technology system. They have practiced management solution to keep track of visits and scheduling, and yet it’s all electronic and digital.

And yet on the research side, they’re still largely on paper. So you’re exactly right. There’s divergence between where the clinical component of a clinic has gotten, versus where the research part of the practice has gotten. 

Well maybe I’ll just throw one more question at you both. Talking more about the future of dermatology research and where things are going, what gets you most excited about the next five years? We’ve had a lot of recent approvals from many different groups. Lots of orals and topicals for the treatment, a lot of indications that , we hadn’t had a lot of approvals recently. Curious ,what gets you both excited and what we should be looking forward to in, in dermatology clinical.

Betsey Zbyszynski: I’ll start. While I do love a good acne study, I like the way dermatology is moving to rare disease and looking at even atopic dermatitis or psoriasis in new ways, a lot of patient reported outcomes. There’s just a lot of different efficacy endpoints as well as patient reported endpoints that are coming into play and being more accepted into trials.

Getting patient’s feedback is huge. So I do love the movement there. I’m sure that’s across all therapeutic areas, but I’m only in dermatology. And I just see that now in almost every study.

Dr. Janet DuBois: I think what I have found the most fascinating. Over the past, say 8 to 10 years in medicine in general. And it does apply to dermatology is the whole concept of the human microbiome and how the disruption of the human microbiome is potentially involved in so many different diseases. To me, that’s so exciting and doing clinical research, looking at the role of microbiome and skin disease to me is one of the most exciting and interesting areas that I’ve seen in my career.

A bit general, but, hey, it could potentially be the answer to so much in the area of medicine and disease. It’s just fascinating to me. 

Betsey Zbyszynski: And there’s some companies that are getting pretty far down the road, at least in dermatology that I know of that have products like this. And even for GI, that’s a big area for microbiome too right?. 

Dr. Janet DuBois: Huge area, just what, they’ve discovered. It’s mind blowing sometimes. If you learn about say clostridium difficile? It’s a terrible infection in the GI tract that usually results from the use of broad spectrum antibiotics.

And then you can do (thankfully we’re not at dinner time) I don’t think anywhere, but fecal transfers from normal healthy guts that can help treat clostridium difficile colitis. It’s just amazing to me. And I think the possibility of potentially exploring the human microbiome, especially gut microbiome and other things like alopecia areata, atopic dermatitis. I think this could be an [00:25:00] extremely exciting area in the years to come 

Simon Burns: Well, whoever had fecal transplant on their bingo cards is cheering up and down on this webinar. 

Dr. DuBois this is phenomenal chatting, Betsey, phenomenal chatting. Enjoy your weekends. And thank you audience for, joining us today on our webinar about technology-enabled dermatology clinical trials. It was an absolute thrill, both. Thank you so much. 

Dr. Janet DuBois: Thank you.

Betsey Zbyszynski: Yeah. Thanks, everybody. Bye, Janet. Bye, Simon.