Dermatology Therapeutic Area

R&D³ Podcast – Episode 5: Dermatology in Clinical Trials – What About It?

In our fifth episode of R&D³, we welcome back our Research Scientist, Jeet Roy, to discuss a very important therapeutic area, Dermatology, where he’ll be diving deeper into the ins and outs of dermatology when it comes to clinical trials, the different digital tools used for this TA in clinical trials, how those tools can help underrepresented populations, and so much more. 

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Jenna: Hello, everyone, and welcome back to the R&D³ podcast by Datacubed Health. My name is Jenna Jordan, and I’m the marketing manager here at Datacubed and the host of our podcast. 

I’m thrilled to have our research scientist, Jeet Roy, back with us on today’s episode. He was actually on our last podcast episode discussing how communication and engagement can increase patient retention and compliance in clinical trials. If you haven’t listened to that episode or any of our other episodes in that case, I highly suggest you do so because they are very informative and just wicked fun to listen to. 

Now, back to what we’re talking about today. Jeet is joining me to discuss a very important therapeutic area (TA), dermatology, where he’ll be diving deeper into the ins and outs of dermatology when it comes to clinical trials, the different digital tools used for this TA in clinical trials, how those tools can help underrepresented populations, and so much more.

I’m welcoming my dear friend, Jeet. How’s it going today?

Jeet: Hey, Jenna. It’s going great, and I’m really excited to be here for another podcast.

Jenna: Awesome, thank you! All right, let’s just jump right in. Jeet, can you tell us more about dermatology in clinical trials ─ what do we typically see?

Jeet: For sure. You know dermatology, it’s a massive and competitive space in the context of clinical trials. Skin conditions such as acne, psoriasis, and atopic dermatitis are also known as eczema. These are very common, and really, none of them have any known cures. So, itchiness or pruritus is really a common symptom associated with a lot of these dermatology conditions, along with inflammation and more increased susceptibility to things like wounds and infections. Often, symptoms for these patients may flare up and be triggered by certain environmental or even seasonal factors.

Jenna: Oh my, that doesn’t sound too good. That sounds pretty rough, actually. It sounds like these indications result in chronic health problems.

Jeet: Yeah, unfortunately, they typically do. Aside from the more commonly known conditions, there are also several skin cancers like Melanoma and other rare diseases within the dermatology space with really, really limited options for treatment. For example, ichthyosis, also known as fish scale syndrome, is a rare genetic disease that results in dry, scaly skin but also a number of other medical complications like dehydration, infections, chronic blistering, overheating, and even rapid hair loss. You can imagine how incredibly uncomfortable these symptoms would be for a day, but much less for a lifetime.

Jenna: I honestly can’t even imagine fish scale syndrome. What are the options for these patients? Can these conditions be life-threatening?

Jeet: Yes. Although skin conditions like these can be really debilitating from a quality-of-life standpoint, they’re more rarely life-threatening. Even Melanoma can usually be managed if intervention is early. However, the psychological distress associated with these conditions can be high, in addition to the chronic physical discomfort and symptoms. For these reasons, there’s a huge need to better understand dermatological conditions and their underlying mechanisms so we can develop new treatments with greater efficacy than you know what’s available today.

Jenna: That’s awesome. It’s great to hear that they’re very rarely life-threatening, but it seems like the perfect place to invest in R&D and digital technology. Do you mind sharing what digital tools are used in dermatology clinical trials?

Jeet: Given the visual nature of most skin conditions and the fact that many of these conditions aren’t necessarily life-threatening early on, virtual visits are an increasingly popular tool for dermatology trials. That’s really because virtual visits greatly reduce the burden for patients participating in the trial and oftentimes can entirely replace site visits. 

Jenna: That makes sense to me. I know I had to do a virtual visit with my dermatologist one time during COVID, and it was actually very helpful and not stressful at all. 

Jeet: Exactly. Even beyond just forms and questionnaires, image capture technology is another related and highly desirable digital tool for dermatology trials. We all are on our smartphones, and smartphone cameras have come a long way in just a few short years. It provides an easy way to remotely capture images for diagnostic purposes or even in the context of those virtual trials we mentioned. The other thing is, for dermatologists, making diagnostic decisions based on a review of images is routine and has kind of always been part of the game. This really helps these digital tools can really help streamline that process.

Jenna: Right. So, in some ways, dermatology studies are already perfect for virtual or decentralized approaches, aren’t they? Or am I wrong with this?

Jeet: Oh, absolutely, they definitely are. And eDiaries are another excellent digital tool for dermatology studies. In many cases, these trials will require participants to apply a study ointment done regularly, like daily or weekly. An eDiary really helps ensure compliance, and it greatly reduces the site burden in monitoring medication adherence. In addition to that, dermatology trials also have participants regularly reporting symptoms such as itchiness, inflammation, and soreness. Therefore, eDiaries are ideal for that type of reporting. It’s way less burdensome for a study participant to complete an eDiary on their phone or Android versus having to trudge through a paper form every single day for months or even years. Related to that, eConsent is also an appealing technology for dermatology trials that are fully decentralized because it streamlines the entry into the study, and that’s pretty powerful considering the massive cost of enrollment per dermatology trial. So, anywhere we can reduce the burden for sites and patients is always a major win.

Jenna: I totally agree. The less paper you need to fill out, the better it is. I’m on board with that. So, it seems like many, if not all, dermatology studies would benefit from these technologies. What should be taken into account when using these tools in the context of dermatology?

Jeet: It’s a great question, and I think one very important thing to consider is that diversity in dermatology trials has always been a key problem area. So historically, racial and ethnic minorities have been vastly underrepresented in the dermatology space, both as physicians and patients. In fact, a 2020 review published in the Clinics in Dermatology journal found that dermatology is the second least diverse field of medicine behind orthopedics. You know, the lack of dermatologists from groups that are underrepresented in medicine just means that inherently, there are fewer doctors who might be familiar with how these skin diseases present themselves in patients from those different underrepresented groups.

Jenna: That’s a very interesting fact to share, and honestly, I’m actually very shocked about that. That’s an important challenge to consider for sure. So, how can dermatology use digital tools to reduce barriers to entry for underrepresented groups?

Jeet: Great point. Any dermatology study that wants to sort of leverage the tools we’ve discussed would need to ensure a few things. The image capture technology should be highly adaptable to different skin tones ─ the best quality images are being reviewed by physicians, especially if it’s in a diagnostic context. Additionally, any electronic reported outcomes or eDiaries used for collecting patient reports of symptoms need to be very carefully migrated from paper to electronic and ensure that the messaging is relevant to all the groups. All of that ultimately means that we want to reduce the barriers of entry for underrepresented groups, and this should be a priority for dermatology trials. Different demographic and regional considerations should always be made to ensure patients feel safe and enthusiastic about their participation in a trial. Establishing trust is very important in maintaining that, and from a technological perspective, we have things like big data and machine learning approaches, which are powerful tools for processing huge amounts of imaging data delineating specific features unique to different individuals and groups in these trials.

Jenna: This is all great information. As much as I would love to keep asking you questions about these points, I’d like to switch gears a little bit if that’s OK with you. Do you mind just letting us know how we at Datacubed leverage behavioral science principles to drive participant engagement and retention in dermatology studies?

Jeet: Yes, behavioral science principles at Datacubed, we really apply those across many different aspects of dermatology trials. Given the chronic physical discomfort many dermatology patients experience, it becomes even more important to appropriately set expectations for studies and really establish that strong sense of trust I mentioned. That means providing as much information to study participants upfront as is necessary, making sure that they’re comfortable and willing to stay in the study past that first visit, whether or not that’s in the clinic or virtual.

Jenna: I mean, that makes sense. I mean, why would somebody stay in a study if they feel like they can’t trust the study team? It’s super important to me, so I 100% agree with that. Can the digital tools that you shared earlier help with this?

Jeet: Absolutely. We always try to leverage those digital tools specifically to reduce patient burden. We want to make it as easy as possible for individuals to take part in the study and also make it easy for sites. For patients, we don’t have them take off work and go to the clinic unless it’s absolutely necessary. There are more options, even drugs getting delivered right to people’s houses, to completely eliminate clinic visits. We can also offer virtual or remote options for completing study activities, and this is almost always preferred by participants. And it can really help them motivate them to stay in compliance and stay in the study long term. Another thing we think about from a behavioral science standpoint is motivation. This way, we utilize digital or monetary rewards at strategic intervals. In a study, this can greatly increase medium- and long-term motivation, especially for longitudinal trials. Keep in mind many of these dermatology patients are diagnosed at a very early age. Setting the right impression with families is critical for ensuring the overall best long-term outcomes.

Jenna: Yeah, definitely. I agree with that as well. It seems to come back to reducing burden and barriers to entry for patients, am I right?

Jeet: Absolutely, yes. And you know, here at Datacubed, specifically in the context of diversity, we also talk a lot about identity law. This is a concept where we want participants to see themselves as true collaborators in the study and, in a sense, actually incorporate their study into their sense of identity. Offering the participants the ability to represent themselves in this digital study world, such as with an avatar, greatly increases the chance of retention. And sort of related to that, repeated positive interactions with study participants. This will have a snowball effect, improve the overall quality of study data, and reduce stressors for sites, patients, and sponsors ultimately. We really want to make it easy for patient feedback to be heard and develop a sense of community within the study. And, of course, within our own digital tools and our app. At the end of the day, incorporating behavioral science principles into dermatology is really a win-win situation for everyone involved, especially in the virtual, hybrid space. Ultimately, we get the combined benefits of increased trust, reduced burden, improved data quality, and improved engagement and retention ─ that’s pretty much the holy grail for clinical trials.

Jenna: Oh, my goodness, well, Jeet, I can’t even begin to tell you how much I appreciate you walking me through all of this. It was such an informative session. I honestly learned so much, and I can’t even wait to talk about this with all my friends. It’s actually very interesting stuff.

Jeet: Sure, it was a lot of fun!

Jenna: Thank you again, and I’m glad you enjoyed this session. Everyone to our audience, we hope that you enjoyed this episode and also hope that you come back and join our next episode in the upcoming weeks. I would like to reiterate that we are now on all major podcast hosting sites, so feel free to check us out on Spotify, Apple Podcast, Amazon Music Podcast, and all the other major podcast streaming platforms. Until next time, I’m Jenna Jordan, and thanks for listening to R&D³ by Datacubed Health. Thanks again, Jeet!