In this episode of Inside Look, Yesha Raval discusses patient retention in ophthalmic clinical trials with Clinical Research Coordinator Chris Bartizal from Midwest Cornea Associates. Throughout the episode, Yesha and Chris discuss strategies for maximizing patient retention, emphasizing the importance of collaborating with a site that is experienced in the study’s indication and has a thorough understanding of its patients. Yesha and Chris also dive into methods for maintaining consistency, flexibility, and transparency when managing patient needs and expectations.Watch the video above for an inside look at subject retention in ophthalmic clinical trials.

The following is a transcript of the above video.

Yesha Raval: Hello, everyone. Welcome to this episode of Inside Look, a podcast from Lexitas where we discuss all things ophthalmology and clinical research. My name is Yesha Raval, and I’m the Operational Strategy Director at Lexitas. I have spent my entire career in ophthalmology and CROs with a focus in operations. In my current role at Lexitas, I leverage my operational know-how to shape strategy for clinical programs. That spans site selection, patient enrollment, and patient retention, which is actually today’s topic. I’m very excited to welcome Chris Bartizal from Midwest Cornea Associates.

Chris Bartizal: Thank you, Yesha. I’m happy to be here, and I can’t wait to get into subject retention.

Awesome. Thanks, Chris. So I think Dr. Nottage’s site [Midwest Cornea Associates] and Lexitas have worked on at least ten studies, to my knowledge, and that spans from dry eye to blepharitis and corneal surface diseases. Can you give the audience a little bit of an intro, Chris, about yourself and what it is that has drawn you to clinical research?

Yes, I started for Dr. Nottage five years ago as her clinical study coordinator. Prior to that, I had just a Bachelor of Science, and I had done some benchtop research in HIV out at Johns Hopkins. I had a friend in clinical research who convinced me that clinical is better than benchtop, so I made the segue over to clinical research, and I love it. I found a job working for Dr. Nottage at Midwest Cornea Associates, and that was my first taste of ophthalmic clinical trials. I’ve been doing that now for her for five years, and we’ve had a very successful run. This has spanned, as you said, more than fifteen studies across a broad spectrum of topics in ophthalmology, particularly in the front of the eye (anterior segment). Dr. Nottage is a cornea specialist, so we look at as you said, dry eye, also different diseases of the cornea, neurotrophic keratitis, and local stem cell disease. So it’s been a really interesting job for the last five years for her.

Thank you. Yeah, I mean, that’s a great background. What drew you to [clinical research] initially, and what tips would you have for people looking to break into the field?

Good question. So this is a field that is known for connections. When I first started, I knew no one, I knew no [clinical research organization] CRO, and I knew very little about any of the sponsors in ophthalmology. Luckily, at our site, we had a seasoned study coordinator who took me under her wing, taught me a lot of the regulatory side, and introduced me to Lexitas as my first CRO. At that point, she retired and I moved on to say, “hey, Lexitas, can you entrust me and Dr. Nottage in one study? Can we show you what we can do?” Then from there, we built a relationship with Lexitas. They did a great job and overperformed on that first study. Over the last five years, I’ve really learned that relationships in this business are the most important. You, as a study coordinator, are tasked with providing a certain number of patients—quality patients— for these clinical trials. The things I’ve learned allow me then to branch out and meet sponsors, meet other CROs, and kind of keep that relationship going. There isn’t just one study in particular that I always strive to have. It was more of, what could we accomplish at our site, and knowing our site’s limitations to provide services to these CROs.

Yeah, thank you. And we certainly value your relationship here. Thank you for your continued support. We want to keep you engaged. I guess I’m gonna take this to today’s topic, which is patient retention. You know, this is so critical and often I feel like we focus a lot more on patient recruitment rather than patient retention. But it kind of goes hand in hand, right? A high dropout rate can compromise the study power, as well as, the data integrity. It can derail the study scope, the timelines, and the budget, right? Because if that deficit is statistically meaningful, it may need to be made up, meaning we may need to enroll again in order to get that bottom line for that program. So at Lexitas, we are patient-centric, and that means that we want to empower you as a site to give our patients a pleasant and holistic journey. That really requires you as the site to be plugged into the community of research participants so you can understand, and collectively, we can serve the needs of the community. So I guess with that said, what are some of the biggest challenges you have faced for retaining patients in your clinical trials?

That’s a great question. It’s a very broad question. I’m going to try to make it into parts. I think the best thing that I can do, the most challenges I’ve seen for subject retention, has been keeping a subject engaged in a study. As a site, we have seasoned subjects that come back to us for trial after trial for certain diseases. We have other subjects that are new to our site. And so you have to take into account, the biggest challenge would be, know your site’s limitations. Do I have a sample size of subjects for that clinical trial that we’re interested in? And do I have specific people in mind or are these people coming off the street and are they a first time research subject for the clinic? Those people that are seasoned are gonna have more experience, kind of know the ins and outs of what a study entails and know what they’re getting into. Those fresh, naive patients who just come in and are convinced that this might be a good trial for them, they have no idea about the length of the trial, what it entails to take eye drops, for example. and any other little intricate part of the study that me, as a study coordinator, that I would have to let them know about. So there’s a big, vast range of problems that could occur if you have somebody who’s new. Even with my seasoned subjects, some of them have to be kept on point with their dosing routine, or how long the study will be, or what to fill out in a dosing journal. So there’s a lot of topics there, and I’m sure we’re going to dive into it with our next couple questions.

Yeah, for sure. I think one of the times we were discussing this, you had also mentioned that your sort of the types of studies that you select are somewhat related to what kind of patients you have, right? And what is going to serve them best. And I thought that was really interesting and a good point that not all sites really take into account.

Yes, yes. If you’re a site, you could have four study coordinators, three PIs. At our site, I’m the sole study coordinator for Dr. Nottage, and she’s the sole Principal Investigator. So for us, you said it correctly, our site tailors to our subject population. If I see a study for something that we don’t really study or see a lot of, then it’s not one study that I try to bid on because I know I’m not going to be able to produce the numbers that the study would require. But we’re talking about subject retention, so I’m stacking the deck for myself when I say we do see a lot of dry eye patients. And so we tend to have dry eye studies here. We do see a lot of medical corneal infections. And so with that, there’s a lot of those studies in the ophthalmic space right now with these NK studies and the limbal stem cell studies. So, I find it intriguing that it’s a range that you at your site need to tailor to what you can provide. And don’t fool yourself. If they want twenty patients for that indication, you need to have, and be sure that you have, that indication in coming through your clinic. Otherwise, you’re going to come up short for this subject enrollment numbers. But for retention, it helps me because I know I can get twenty dry eye subjects. I have a list of people that I trust with the longer studies and then the shorter studies.

Yeah, so I guess my next question was, can you share success stories where the site has excelled at keeping patients engaged throughout the study?

Yes. So a great example would be this year-long dry eye study that we just completed. That study involved having subjects over multiple visits for a year dosing in both eyes. And so because of that, I was worried that we’d choose twenty subjects that probably couldn’t last that long. So, I really went through my dry eye database to find the ones that I knew could last. But even so, that’s a lot to ask of somebody. So in the contract for this study, I was able to tier the amount of subjects stipend that the patient receives per visit to increase as I got closer to that year mark, so they knew that they would earn a little bit more if they came in for the second to last visit and the last visit. And that financial incentive kept them in the study. Also, I wrote in a fifty-dollar gas card that would be given to them halfway through the study as a small perk to say, hey, I understand this is a long study, and you’re driving to me a lot, but here’s a fifty-dollar gas card from the study for you because you’ve made it halfway. With that, it’s a long study, and I have given them study updates throughout to kind of keep them engaged with the study, saying you are part of this study, and we need you, and this is how everybody else is doing. And it worked! We had very little dropout for that study. I was worried at the start that a year-long study wasn’t going to make it, but we were over ninety percent enrolled and it’s completed.

I love it. That was sort of my next question, and you’ve already sort of delved into that, but really what strategies and tools do you see being most effective in encouraging patients to be in a clinical trial. And I think what you said, which I wanted to highlight again, is keeping them as part of this, you know, journey with you. So I’ll let you go a little bit into that as well.

Yes. So another angle you can take on that question, Yesha, would be- you involve the subject, not as a number in the study, but as part of the study or as part of the clinic’s family. I like to let them come into the clinic, tell me, hey, how’s it been dosing for the last couple months? Any problems? Anything wrong with your study journal? Oh, you know, I heard that at another site they had this issue. Are you having this issue? And so I really give them an update on the study that they’re currently in. I allow them to speak and get to hear them tell me their woes or their compliments of, hey, you are a hundred percent compliant dosing this last quarter and you did great. Good job. Give them that pat on the back and say, “Because of your great work, we are going to get a compliance rating that is a hundred percent compliant. Your data is really going to matter.” They don’t understand that they’re not just coming into dose and then go home and dose again. They become part of this bigger picture of completing a clinical trial that could come to market. So they get really excited about that. Involve them and make them feel that their opinion matters as they walk through the door, not just sit them down, run through the source and then kick them out.

Yeah, I mean, I can’t agree anymore. And then I think with that actually kind of ties again into the next question I had, which is, how do you educate patients about the importance of them completing the clinical study? Some of it you already touched on.

Yes. So, I think if I was a new subject off the street coming to a clinic for my first trial, I would have no knowledge of what I’m about to step into. I think educating them both, obviously, from the informed consent all the way through to the completion, they learn very quickly that their assessments matter and that they need to be done via the protocols standard and done consistently each time in the same way.

When they come in, they get used to that routine. A lot of these people are used to the routine, and if they get used to it then they get better at it. Doing the same assessments, having the same assessors do the assessments, allowing them to see the same PI if it’s possible at your site. Those are all good ways to give them that chance to build a relationship with your site.

Whether it’s a new patient or a database patient who’s been here five times, I’m always the one there to greet them. I don’t make them wait very long. I try to involve them with the scheduling of visits. And I’ll go into that a little bit later with you. But it all stems back to involving them as part of that study family and giving them updates of, “Hey, we’re almost there. Enrollment is closed. We are two visits out from the last study visit, and you will get your study check at the end. You’re almost there, stick with it.” Then reviewing those dosing diaries is a lot of what I do. That would be, “Hey you know what you missed a couple doses here, what was going on in your life?” Ask them about their life. They will gladly give you some detail, and you guys will build that relationship from there and help the study by maybe influencing it to have better dosing compliance.

Great segue. And yeah, so familiarity, communication, really inclusion all sounds like it’s part of your strategy. That’s actually my next question, which is how do you establish and maintain that trust with your patients, especially with the long-term commitments?

Okay, so since I have been here for five years, I’ve had the ability to kind of track which patients are the better subjects to do a short study, which of these are potentially better for a long-term dry eye study. And then the ones that are medical, that I only get to see once and I typically never see them ever again. You have to know your audience. Who are you talking to, and who’s going to fit this bill best?

Using the example of that year-long study, I had somebody who I thought would be perfect for it, but her life was just a little bit crazy this year. She was not a good candidate for that study. I couldn’t foresee that. You learn how to ask them about themselves. When you do that, you get more detail that helps you understand, well, maybe this person is just better for a short study. When I do that, I take a little note, I write it down, and then the next time I have a short study, I actually reach out to that subject and say, “Hey, this is more like the three-month studies that you’re used to. Would you want to try this instead of that year-long study that you decided not to do and that we discontinued you from?” Those little notes helped me judge my patient population better if you have a fresh subject off the street it’s harder to do that so it really depends on your clinic and what kind of consistency you have do you have the same study coordinator calling the same people.

Amazing. Yeah, I mean, it really, you know, I think the more we have this conversation, the more it sounds like you guys have figured out that the best way to do this is to provide each patient like almost a tailored approach to what works with them and what works with you guys, which obviously when you have that alignment, we see a higher success rate with patient retention. I really appreciate that. That sounds great. My next question is, what steps do you take to ensure that patients are feeling valued and supported throughout the entire clinical trial process?

Great. So, this is where the study coordinator and the person potentially doing the contracting works best. I’ve used Lexitas as a CRO now for multiple studies, and so when it comes to contracting talk, I, as a study coordinator, try to build in a decent subject stipend, financially compensating them for their visits. I also make sure that if it’s a study where we’re casting a wide net for our study, say anywhere in the state of Indiana- where we’re located- I would ask them to write in a travel stipend where if the patient travels more than fifty miles round trip that they get the IRS’s reimbursed mileage, so that they feel like they can drive to us from two hours away, be compensated for their travel per mile, and then get to our clinic and say, well, that was worth driving here two hours. If it’s on their own and they want to come to us for two hours and there’s no reimbursement, typically they’ll stop coming. It’s just too much of a burden for them.

Then there are also other things you can do if you are hurting for subjects in a specific study. I’ve reached out to different internet-based recruitment companies to help find me and cast the net around my city to help try to find patients that would be in my indication for the study that I’m interested in. Typically, when it comes to contracting, I try to write those into the contract so that when the patient comes, they’re compensated for their time and their effort. Obviously, there’s other things we can do, and you and I will touch on those other benefits into that money, but it can’t just be money. I think for a subject to be valued, they really, really need to be involved and say, hey, this is something that I have a problem for, and I want something that can potentially solve my dry eye. And I’ll say, okay, well, this is one of those dry studies where you could potentially have an eye drop that helps you with your dry eye. Would you want to enroll in this study? Those recruitment tools and those enrollment tools, they help. But if you have somebody who the money doesn’t mean anything to, they really want a medication to help with their disease, then you have to target your speech towards that for them.

Yeah, you touched on a lot of great points and I think, you know, to sort of sum it up a little bit would be- communication. making your patient feel valued, really giving them that holistic journey almost. I’ve worked in clinic where patients come in because they found it as a social aspect to it too. So getting to know the site, as you mentioned, so you do have to put in that time I think to establish that trust, to establish that long-term relationship, and then also reducing the patient burden where possible. As you said, helping with gas, helping with the stipend, making sure that they feel that their time is valued, providing meals if it’s a long visit. Any of those smaller parts that are not really money, but they can feel valued. We know that we value those patients from the time they are recruited to the time they complete the study. So I think really sort of getting to know your community and selecting the right type of studies based on that sounds like a really good strategy. Are there any other closing thoughts and tips you have for why you guys see a lot of success with your clinical trials and what other sites could possibly learn?

Yes, so obviously when I first started this job, I did not know the ins and outs of the subject retention. So over the last five years, what I have built on is the fact that these subjects never want to be treated like a number. They have real lives and you touched on that with the sense of community. I think to dive into that idea- my subject, let’s say, Yesha, you’re my subject. You come to my clinic. Yesha has her real life in the background. She is more interested in her real life than the day-to-day of my study, but she is signed on to do this study. I, as a study coordinator, have access to tools such as a visit calculator. The visit calculator allows me to tell Yesha when her visit window would be. As a study coordinator who’s involved with Yesha in her life and wants her to be committed to this study, I’m willing to say, you know what, Yesha, we could do every Friday for the next three months? Or, hey, I realize that you’re a real person with a real life. Here’s my visit window. We could do Thursday, Friday, or Monday. What works best for you?

Just by taking that extra time- it might inconvenience you and your clinic a little bit- but as long as it’s still your working schedule, ask them. Maybe Friday is not the best day of the week for the first three months. And maybe giving her an option of a Thursday or a Monday shows Chris is really trying. He’s trying to work with me around my life schedule, and I’m willing to stick with the study because I don’t have to sacrifice every Friday now. So that visit calculator works well for me at my site. That’s a little tip and trick I have.

The other thing is, you touched on this, the food, if they’re staying for too long from a long distance, and a lot of my studies are that, we give them food vouchers that are written into the contract from the sponsor. We also provide a hotel if it’s longer than a two-hour drive one way. So there’s perks, as you described, not just financial compensation, that allow them to say, I can make this happen in the reality of my life now. That’s going to be your real true goal for subject retention. Otherwise, it’s too hard. I don’t want to give up another Friday, I’m not going to come into my study visit, I’m going to stop taking my study dose, and then you have a discontinued patient. That really hinders our data. So I include them in subject study updates. I include them in study stats, if they want to know, hey, how close to finishing are we and will we have enough compliant patients? I try to give them as much detail as I’m allowed to give them so that they stay engaged for that whole period of whatever the length of study is. But then I also try to work in that reality of this is your life and you’re involved in a study, not the other way around. The study doesn’t take precedence over your life.

Thank you. Yeah. I mean, I’ve been doing this for a long time, but it’s always still refreshing to hear more ways for how we can support our sites to then support our patients. So thank you for that. I guess as last closing thoughts, is there anything that you think that the CROs and sponsors can be doing that they’re not doing to help you with patient retention?

If it’s patient retention, I have seen multiple studies where protocols have changed in the middle of the study. And we all know this. I mean, you know this from your end. I ask that you don’t dramatically change anything for the study halfway through the study as a CRO or as a sponsor. Because that makes the subject lose trust in me and my site, when suddenly now they’re not coming in once a week, they’re coming in twice a week. Or you promised me that there would only be a blood draw at the start of the study and the end of the study. And now the informed consent has been changed so that there’s a blood draw at every visit. I don’t like being stuck that many times. These are examples of things that hinder what I promised them at the start that they then say, well, this is too much. This is the breaking point. But no, as far as a CRO and sponsor, show what you are going to show, what you’re going to require of us at the start and please try not to change it throughout. That would be my biggest ask.

Okay, great. So just clear communication, making you guys part of our partners and having that be very clearly communicated and have that partnership, I suppose. Well, thank you so, so much again for joining us today, Chris. It was great chatting with you. We’re very grateful, not just for your time today, but your partnership with Dr. Nottage’s site and Lexitas. And we hope to continue that from there.

And thank you, as always, to our listeners! If you enjoyed this episode, let us know in the comments. Be sure to follow Lexitas on YouTube and LinkedIn so that you don’t miss an episode of Inside Look again. And you can subscribe to our quarterly newsletter, Visionary Insights, for new episodes and exclusive content. Thank you so much. Thanks again, Chris. We’ll see you next time.

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