Through the Lens: The Role of Ophthalmology in Clinical Trials

Ophthalmology, a medical specialty focusing on the structure, function, and diseases of the eye, has a growing role in non-ophthalmic studies. Jessica Mays, Vice President of Life Sciences at 20/20 Onsite, shares common challenges sites face with trial-related eye assessments and how to accurately budget for these types of services. Tune in to learn how 20/20 Onsite is making ophthalmology research more accessible to sites and patients through mobile services.

Transcript

Jimmy Bechtel: 0:00

Greetings and thank you for being part of the Society for Clinical Research Sites on SCRS Talks. I'm your host, Jimmy Bechtel, the Vice President of Site Engagement with the Society. Get ready to dive into pressing clinical research industry topics, celebrate noteworthy achievements, and create a deeper connection with the research community. This is a space to amplify voices and perspectives that shape the landscape of clinical research. Today, we have Jessica Mackenzie Mays the vice president of life sciences with 20/20 OnSite, here to share a little bit more about what they do and how they're doing some really interesting and we'll say reshaping things in the ophthalmology space. Jessica, it's great to have this opportunity to chat with you today. Really excited to learn more about 20/20 OnSite and what you guys do in this sometimes untalked about therapeutic area, very specific therapeutic area. But before we jump in to learning about the company, I'd love to learn a little bit more about you.

Jess Mays: 1:00

Perfect. Thank you, Jimmy. Really excited to be here. Obviously, our company is big fans of SCRS and the community. So I think this is an important topic and I'm, really thrilled to be able to share it with you. My background is pretty interesting. I started in my early career in a software company that was one of the first online IRB submission softwares, working with sites and helping them make that tedious switch from paper documentation to electronic documentation. And then I went out on a journey of working at different startups and different early stage companies. So really tackling problems that haven't been tackled before, doing them in a new and interesting way, which is what brought me to 20/20 OnSite. So for the last four years of 20/20 OnSite,since we made a pivot into clinical trials from the pandemic, I've been at the helm of really understanding what is the role of mobile ophthalmology and clinical trials and how can 20/20 OnSite support more sponsors and CROs and sites and, really get those drugs to market.

Jimmy Bechtel: 2:01

Really cool, Jess. And can you then, elaborate on what 20/20 OnSite does specifically?

Jess Mays: 2:09

Yeah, absolutely. So we are a mobile ophthalmology vendor, which is a mouthful, but really what that means is that whether it's on wheels or whether that's bringing equipment or people to places where they otherwise wouldn't be, we're able to take Any range of ophthalmology equipment and any range of ophthalmology expert from a technician, optometrist, ophthalmologist, and bring them to where assessments are needed. And in clinical trials, what that means is that if you're a psychiatry PI, and you're working on a major depression study, and there's a fundus image as part of the protocol and you don't have that resource at your site. We can come in and be your support. So you can still run this program through your brick and mortar site. You don't have to purchase more equipment or find a vendor down the road.

Jimmy Bechtel: 2:58

It's really, really interesting because I know when we talk ophthalmology, right, most people probably go right to ophthalmology studies, ophthalmologists and eye care. But what we know in the clinical trial space is that ophthalmology has a role in so many different trials and not even just optho specific trials. So can you share a little bit of insight into how common this is across therapeutic areas?

Jess Mays: 3:24

Absolutely. You're, really hitting the nail on the head. So to sound a little poetic for a minute, the eyes are the windows into the soul, but also into the body. You can tell a lot about what's happening in a body through the eyes. You can tell what's happening in the vascular system, in the nervous system. You can tell if there's any issues with blood pressure. You can diagnose a whole host of issues through a simple noninvasive eye exam. So what we've seen over the last decade is that the ability to take really high definition images through the eye and understand better what's happening in the body means that you're having less invasive procedures for the patients. What this has meant for clinical trials is that we're seeing an uptick of these types of photographs or assessments on non ophthalmology trials because you're trying to get that safety data. You're trying to understand the holistic picture of how this is interacting with the patient and their body. I've been seeing a lot of FDA mandated ocular sub studies or ocular endpoints as well. So, I don't have a I don't have an official statement on this, but it does seem like something that is going to keep increasing in the industry. This prevalence of ophthalmic exams on non ophthalmology trials.

Jimmy Bechtel: 4:34

It's so interesting. And I'm sure that people that are more, we'll say ingrained in, or in the middle of the clinical trials that would warrant the conduct of ophthalmology exams and the, Molecules and therapeutics that might affect eye health would be more this, but it's it's sort of one of those ancillary things that you don't always necessarily think of right away, which is probably exactly why 20/20 OnSite is in business. Because it's not something that every clinic or every research facility may have the equipment to be able to do. Again where you guys come in. So that's a really great point.

Jess Mays: 5:11

And I think, to also level set on why this would be an issue that wasn't already solved in the market when it comes to the prevalence of ophthalmologists, I'll just give you a little bit of data. So there's about 18, 000 ophthalmologists in the United States of those only about 2, 500 or retina specialists. They tend to be in urban areas or other really popular areas, which means that we're creating a lot of. ophthalmology health deserts across the U. S. So there are places where there may be patients and research sites that want to participate, whether it's not an ophthalmologist and what would happen in a in a normal situation where 20/20 OnSite wasn't involved is that if you wanted to be the P. I. On this study, and you saw that this was on the protocol, it usually falls to you to find that outsourced ophthalmology, so you'd probably be looking down the road trying to find an ophthalmologist. And then that opens up a whole host of questions. What's their schedule like? Can they fit your patients? How does that work with your schedule of assessments? And when you need to collect the data, that's generally pretty tough on a phase one where sometimes you're going down to the minute when you need to take an assessment from someone and then you have to contract with them. Are they good at filling out their exam forms? You know, are they all GCP? Do they check all the boxes? I mean, clinical trials is so highly regulated. So it just creates a little bit of a mountain out of a molehill for something that might seem really insignificant in the big picture of the protocol, which is one little fundus exam, can cause a whole lot of stress, I think for sites. And then that gets passed downstream to the sponsors as well. When, if you don't find it or it's not working out, it can delay a trial. And I think it's really unfortunate to think about an eye exam being the reason that something like a neuro study or one of these diabetes studies doesn't move forward. That's, that's not what we think about being the biggest focus for these types of studies.

Jimmy Bechtel: 7:03

It's a great point, Jess. And my mind went immediately to opening up the possibility to conduct clinical trials in those remote areas with patient populations, right? Diverse, just as deserving patient populations for clinical trials, but because there is not a retinal specialist or, some of the other Specific actions that might be required of a clinical trial that you had mentioned in that area that those patients or that clinical trial site has access to. You kind of close the door on the opportunity for them to participate in those clinical studies and, we could imagine and probably name off several different therapeutic areas and treatments and classes of drug or device that would kind of fit into that category. So it's a really, really interesting conundrum. It's great to see that there's a solution out there that we hope to raise a little bit more awareness for sites around. So can you talk a little bit about then for maybe me, I guess someone who hasn't been into this space as, as intently what kind of eye assessments are required for clinical trials, especially for those non optho specific TAs.

Jess Mays: 8:11

Great question. It does vary. So I'll just spit off a list of some of the most common ones that I've seen lately. Usually seeing something along the lines of a comprehensive eye exam. We'll see a dilated fundus exam, sometimes accompanied by fundus photography. The use of the slit lamp. And an O. C. T. I'm seeing a lot more with an O. C. T. Especially on neuro studies. I had an interesting conversation with some neuro ophthalmologists lately about where the role of O. C. T. is going in Parkinson's and M. S. And epilepsy studies. You might do some ocular motility testing in the diabetes space. There is a testing called E. T. D. R. S. Which usually goes along with a certified lane and requires a very specific setup and chart and then color vision. Those are probably the top ones that I've seen, over the last year.

Jimmy Bechtel: 9:02

Running the gamut, right? It sounds like we're there. That's a lot of different tests for a lot of different TAs. I can imagine. I do recall. When I was at the site several, several years ago now walking patients across the street to our ophthalmology clinic, and we were multi specialty. So we had the luxury of a regionally recognized ophthalmology clinic, walking them across to get their very research specific eye exam. And conducting some of those specific exams that you had mentioned there. I can't remember what the TA was but we did a lot of neuro and a lot of diabetes, which you mentioned specifically. So very likely, very likely was one of those, but that's, that's very interesting. So Jess, then how can sites take that to where they need to go and assess the required eye care within protocols and Accurately price it in their study budgets? Because these kinds of things that the site might not do this all the time, that list is long of things where they might have difficulty doing their cost analysis and understanding their costs and really trying Making sense of what those requirements are, if it's not something that they do regularly, because even some of those, tests,- you, rattled off several acronyms there- and if no one's ever done those before, they might not recognize even what those are or, what's required of them or how to even approach their ophthalmologist to recognize whether or not that needs to be done. So again, what can a site do here? To kind of take the first steps into doing an appropriate assessment of capability and costing?

Jess Mays: 10:26

There's a, whole lot in that question, so I'll try and make sure to get to all of it. Let's start with price, because if there's one thing that I've heard from the SCRS conferences that I've gone to, it's that we have to live at a happy intersection of cost effective for sponsors, but priced right, so that sites can keep their doors open and have happy employees and continue operating. And I would say the number one thing that I see oftentimes is that the opto endpoints have been underpriced, especially if the, if the site isn't familiar with it. That may work if you do have what you had, which is a great relationship across the road. There's no transportation involved. It sounds like their schedule worked with your schedule. But I do think that that's quite limiting for sites. And to be honest, I think in this industry, price is something that we all have a hard time getting our hands on, right? It's a little cloak and dagger but what I would say is that my gift, to the world is that I'm not interested in information gatekeeping. We are actually going to be putting out a piece of content where we are going to list these common exams, the piece of equipment that you would most likely need for them, the level of certification of the person that should perform it and generally a price range for what it would cost to do that in hopes that if there is a study coordinator out there that sees one of these on one of their protocols and has no idea what to do with it, it gives them a starting point when they're looking at that initial budget.

Jimmy Bechtel: 11:48

That's excellent. It's great to see and hear of resources like this again, just to kind of give sites a place to start. And I'm sure it will also aid in their assessment as to whether or not that's something they're capable of doing. Because I could imagine that from an economies of scale perspective, even if I might have an ophthalmology clinic kind of down the road. It's still very likely could make sense to employ a service like 20/20 OnSite just from a savings perspective. So that's really, really cool there.

Jess Mays: 12:16

Yeah, I might also add something onto there as well, which is that the exam form is another area where I see that that can cause a lot of pain and confusion at the site level when, it's been dictated that there's an ophthalmology endpoint, but there's been no ophthalmology oversight in the exam form. So what I would recommend if a site was to see this, that they would ask either the sponsor or the CRO To weigh in on or to help them develop a standard exam form to give to that ophthalmologist down the road rather than waiting for that ophthalmologist to give you their exam form. Because on the day to day basis it will save the site staff from having to enter in and translate information about ophthalmology that they may not be familiar with and instead can create a better one for one exam form to EDC data transition.

Jimmy Bechtel: 13:04

That's incredible and a really great example of a little take away for those sites that are listening and a consideration that they have here. But speaking to that, Jess, as we begin to wrap up here, what other advice or resources are available to sites without that ophthalmology experience?

Jess Mays: 13:22

I would say, most of the big CROs have within them the pillars of ophthalmology, neuro, et cetera. So don't be afraid to ask especially for CRO guidance. If that's, who's involved here. I would also say 20/20 OnSite, our door is always open. From a, study perspective, it's not always cost effective to bring us in for, one study for one O. C. T. For one patient. And we'll be the first to tell you that. But I think it's important to at least know what you're getting into. And I would love to hear from sites how we could be more helpful, if I'm being honest. This piece of content was a good start, and sort of exposing an area that if you're not in ophthalmology, it can be a little hard to understand what's happening in ophthalmology. So perhaps we can start to open the doors and shed some light. And if there are things that sites struggle with from this, I would actually love to hear it.

Jimmy Bechtel: 14:12

Absolutely. And I Encourage those that are listening, connect with the 20/20 OnSite team. Connect with Jess. And I think a great piece of advice is bring it back to your sponsors and CROs. Ask them. get that help that you need because you're right. While 20/20 OnSite is a great solution and it sounds like a really resourceful, valuable player in this space. It might not be the solution for every single study out there but it's great to hear that you're again, like you had stated so eloquently, your door is open. So thank you for making yourselves available to the research sites. And thank you Jess for participating in our discussion today. It was great to learn a little bit more about this space. One that I'll admit, I've only been ancillary involved in as I had mentioned years ago when I was at the research site. So thank you for providing some additional color to the great work that you guys are doing and this really important aspect of conducting the modern clinical trial.

Jess Mays: 15:08

Thank you so much. It was such a pleasure to share this with you. And I hope that this leads to more conversations so we can ultimately make everything better in clinical trials.

Jimmy Bechtel: 15:17

Excellent. Couldn't agree more. And as we wrap up for those listening, don't forget to explore other site focused resources made available to you, like various publications and webinars on our website, my SCRS dot org. Thank you again for tuning in and until next time.