An Insider View on Clinical Trials in Ukraine - Roman Fishchuk

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HANNAH LIPPITT: Hello and welcome to the Totally Clinical podcast brought to you by Teckro. Totally Clinical is a deep dive into the freshest trends, big-time challenges and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders and, most importantly, the people benefiting from clinical research. So, tune in, settle back and don't touch that dial. It's time to get Totally Clinical.

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HANNAH LIPPITT: This week, we have a very special podcast guest, Roman Fishchuk, an ENT

doctor and principal investigator who works for a clinical trials unit based in Ivano-Frankivsk, a city located in western Ukraine. Roman updates us on the latest situation on the ground for both the average person and for clinical trials and puts into context the current safety situation in Ukraine. Roman is also a Teckro user and explains how Teckro helps to address some of the challenges investigators and site staff face in a country suffering from disruption, whether war, natural disasters or other unforeseen situations.

Welcome to the podcast, Roman. Can you start by explaining what the situation is right now on the ground across the country in Ukraine?

ROMAN FISHCHUK: It is quite challenging in some areas. It's more challenging than in the others. We have a full-scale war with Russia right now. The front line is in the east and in the south, but the whole country is affected and even a few minutes ago, we had an air raid siren here in Ivano-Frankivsk so we had to go to the shelter, and I am at the hospital right now, and all the patients, all the employees who can do that, they go to the shelter, and the hospital created good conditions for the patients who are not able to move around to be in the basement all the time. So, surgical patients, patients from the ICU, they are located in the basement, so they don't have to be moved every time we have an air raid siren. Here we can have up to four air raid sirens a day. Closer to the front-line people can have it, you know, five, six, up to 10 times a day, even more.

HANNAH LIPPITT: I know that the situation really differs depending on the region and some areas are much more affected than others.

ROMAN FISHCHUK: Yes, absolutely. So just the recent developments in the war, so Russia has been targeting our power, infrastructure, electricity, they used the drones, the missiles and some of the big power plants were hit, including the one in western Ukraine about

20 miles away from where I work and live, and a lot of places in central Ukraine, eastern, southern Ukraine, they have power cuts, so we had it as well. And according to our president, about 40% of the infrastructure that provides electricity – not only for internal market, but also that we export because we export a lot of energy – it's been damaged. But our services, the people who maintained all these electricity and power plants, they are doing really great job in renovating, restoring where they can do that. So again, Ukraine is such a huge country, and I think that's what many people underestimate because in western Ukraine, where I live and work, the situation is much safer than in eastern Ukraine or southern Ukraine. And here in western Ukraine and central Ukraine, where Kiev, the capital is, we have to support our army. We are working, we need to provide medical services to the patients, we want to do clinical research and we need to run the economy so we have the taxes to pay and to help the army win this war as soon as possible.

HANNAH LIPPITT: A lot of people wouldn’t realize that. There can be real misconceptions around how different regions are and how life is for the average person in the country. Can you explain more about the daily struggles for Ukrainians and things that you used to take for granted that are now really difficult?

ROMAN FISHCHUK: Yeah, that's, you know, the war has been going on for more than eight months now.

And it was really difficult in the beginning, especially once you're used to being so flexible and free in terms of your mobility, your movement around a place is open 24/7. Now because of the war, we have a curfew. So, in most places, shops, grocery stores, markets, cafes, restaurants, they all have to be closed usually by nine, 10 p.m., because the curfew starts in most places at 11. And because of the electricity outage, you know, it gets really dark and we don't have any city lights in most places after nine p.m. Even when all the attacks on the electrical system were happening, we didn't have any city lights at all in the evening. But because the number of car accidents increased dramatically, by a quarter – by 25% – there was a decision to turn the lights on in the cities in the morning and in the evening so people can get home safely or to the places where they work.

So, these are the things we didn't even really notice in our daily life, you know, like light bulbs and just light in our houses. We're being recommended to use as little as possible: things like microwaves or electric kettles or washing machines, ovens. We are asked to use that after the curfew because then this will decrease the load for the power system – the electrical grid. These are the things we don't usually appreciate in the daily life, but the things that you do think about and the things you need to consider if the country is at war and your electrical grid – electrical system – is under attack, then especially the winter is coming. And we do depend a lot and winters tend to get cold – sometimes we had -20 Celsius in some areas. So we need to heat our houses and apartments and without electricity, it will be very difficult to do. That's why we try to get the generators to get backup supply of energy and even clothing. Just get the supply of clothing, power banks for the cell phones, for the laptops, just to have some like a backup plan in case, electricity goes out.

HANNAH LIPPITT: If we talk about more specifically about where you're based in your hospital, could you describe

what you provide for general clinical care and the scope of clinical research at your hospital?

ROMAN FISHCHUK: So as an ENT doctor, I provide services to patients who have complaints in ear, nose and throat, both adults – I consult adults at the hospital where I work – and I examined children, especially to do a very specialized test like auditory brainstem response, auditory steady state response – I do that at another facility. As an ENT doctor, I provide these services – consultations – at different specialized tests, examinations. I used to do surgery, but because of my health issues, I had to quit surgical activities. So I focus more on diagnostic techniques and just conventional treatment methods, like prescribing medications or referring patients to get surgical care in other centers.

So, as an ENT doctor, I do that and the clinical research is a huge part of my work as well. I am the head of the clinical trials unit at the hospital, so I'm responsible for everything in terms of clinical trials at the multi-specialty hospital. So everything from contract, budget negotiations to human resources planning, finding clinical trials, daily management of clinical trials, conducting patient visits, communicating with sponsors, CROs, regulatory submissions, ethics committee

submissions. So, pretty much everything.

HANNAH LIPPITT: How many patients are still coming into the hospital? How many are you seeing each day?

ROMAN FISHCHUK: As an ENT doctor, I do see that less patients are coming to the hospital for consultations, and that was caused by, sometimes by the fear of the patients coming to the hospital. It's not very convenient for them because when they come to the hospital and there is an air raid siren, we stop working. We can't see patients because we all have to go to the shelter. If the condition is not that critical, they try to do some sort of telehealth. So, they would call you on the phone or they can use different messengers or applications on their phones to get the consultation remotely. When the condition is severe and they feel really bad, then they come to the hospital and they get admitted to the hospital, to all the tests. On a routine day, an average ENT doctor would consult 15, 20 patients, maybe less. On average, we have about 10, 15 patients at the hospital, being treated as inpatients.

In clinical research before the war started, we had approximately 200 patients that were participating in clinical trials at the hospital, and they were with different indications. So COVID inpatients/outpatients, respiratory diseases, rheumatology, cardiovascular conditions, GI conditions – gastrointestinal, I mean – neurology, so different ones. ENT as well. And I'm happy to say that we didn't lose any of our patients after the war started, only one or two moved to another country, but we managed to follow up most of them. Patients do come to the hospital for routine visits in clinical trials. Now, because of the war, most of the sponsors and the CROs, they put all of their recruitment on hold and no new trials

are being started. So we're pretty much finishing with the trials that we had before the war started. And we still have a few – about 20 patients – who are still actively participating in clinical trials at our site.

HANNAH LIPPITT: If we move on to your experience in clinical research, how did you come to be an investigator in Ukraine?

ROMAN FISHCHUK: Well, it's very interesting. And since I got into medical school, I was really into research and I started participating in research groups to start from my first year of medical university. So I'd started going to international student conferences. The first one was in Berlin and I went there when I was in the second year of medical university. After that, I noticed that most of the research internationally was done and many publications were from big randomized multicenter clinical trials and I was wondering what that was, because at that time I had no idea what a randomized clinical trial is. So, I was also a medical research director at a European medical students’ association. So, I got to know more about research. When I finished medical university, I got into internship or residency in ENT, and that's when I found out much more about it. I did a few fellowships abroad at research

institutions, and I wanted to connect my career with research as well. And probably 2016/17, I approached the hospital director where I work now and offered him to develop clinical trials as the area of the hospital work because they were done randomly, not organized well, so I offered him to do that and that's what I've been doing since that time.

HANNAH LIPPITT: You know, one thing that's interesting that I've learned whilst hosting this podcast and speaking to guests around the world is just how different the approach to clinical trials can be, depending on the country. What are the challenges in normal times, so to speak, of running trials in Ukraine, and how do you believe they can be improved?

ROMAN FISHCHUK: Well, I'm sure that all countries have their own challenges in clinical trials, and some of them are similar, some of them are different. In the last five, six years that I've been involved in clinical research, I see that one of the things I would like to see improved is just cooperation and communication between the research sites and the sponsors, CROs, because usually most of the misunderstandings we get and most of the things we discuss are related to communication. So this is quite difficult for us, the people we communicate with, they change so quickly and so sometimes in a year we can have five different CRAs in one protocol, which is not good for us and for the company. I think it's bad for business because every person comes with his or her own vision on how things should be done and then we get into all these discussions where it has to be done this way or the other way. So I think the major issue is and challenge is communication with the companies, then there are a lot of issues related to logistics because we see that logistically clinical trials in Ukraine could be improved in terms of shipments of lab samples. You know, some small things that we work with on a daily basis. We see that they're done so inefficiently, and you know, by improving them, we could, first of all, save a lot of time and effort and money for the companies who pay for the trials.

Another issue we face, and I think this is quite common globally, is the stereotype and perception of clinical research and clinical trials in the community. Because I thought that only people in Ukraine had this image that, you know, clinical trials, it's like, you know, the people are considered to be guinea pigs. But after going to different international meetings and talking to people from other research sites and industry from other countries, this image and this perception stereotype is present globally. And this is something that we can improve, I think, by educating communities and by just spreading more information about what clinical research is, how important

clinical trials are. From our side, we did quite a few educational events locally and online just to talk about what clinical trials are, how they're done, how safety of the patients is preserved in clinical trials, how safety is the major concern in clinical trials for everyone, both for the sites, for the sponsors, for the CROs, pretty much for every person involved in clinical research.

Yeah, so these are the challenges we face every day. Most of them, to be honest, I think they are universal, globally.

HANNAH LIPPITT: Now you’re a Teckro user, which is great. Could you explain how you came across Teckro and why it appealed to you as an investigator?

ROMAN FISHCHUK: Teckro is one of the applications that makes our lives as investigators much easier. And that's another one of the challenges that we have. We have to work

with so many platforms, so many technologies, so many different software and devices. And, you know, if you have 10, 15 different trials in different indications and every company, every CRO uses its own set of software, set of devices, in one trial, we can work with up to 10 different systems online. It can easily confuse you and we're always happy when the companies introduce software or technology that sort of makes things easier for the site and also for the patients.

The app

helps us. We have everything in our hands, in our cell phones or tablets and now especially you have a web-based version. It is really helpful in our daily work because for example, if a patient comes in and then I need to make sure that I don't miss anything in the visit, then I just open my cell phone, my smartphone and open the app, and then I can check everything to see if I didn't miss anything during the visit. And this is very, very helpful. So instead of going looking for the printed version of the protocol or go into my computer looking for a PDF, I just use my cell phone which is just in my pocket so it makes life easier and gives us this flexibility.

HANNAH LIPPITT: Do you have any examples of how Teckro could specifically help investigators and other site staff in Ukraine operate in difficult conditions?

ROMAN FISHCHUK: It gives us the flexibility. So, right now during the war, or even if during a hurricane in Florida or any other disasters that happen all the time globally, you don't always have access to printed resources that you have or that you were provided with. For example, now at the hospital, part of the hospital is a military hospital so we don't have access to some of the facilities, some of the research rooms we were able to use before in the clinical trials. We do have some of the materials there and instead of going there looking for site file or protocol or things that we need for patient visits, I don't have to do that. I just, I can use the app and check everything I need there. A useful thing is that we can see all the newsletters, emails that are related to a study in Teckro as well. I mean, this is not something that you check all the time, but it's useful to have it in the phone instead of looking for it in the email, because you just have your specific protocol, you go into the updates and then you can find the document you're looking for. So, I think these are practical things that we appreciate and in the software, so it saves us time. It gives us confidence in that we are doing the right things and that we're not missing anything if we conduct a visit for a patient.

HANNAH LIPPITT: Finally, from the outside looking in, there's a perception that the whole of Ukraine is unsafe. And I know you need companies like pharmaceutical companies to come back to areas that are currently stable, like where you're based in western Ukraine. What is your advice for leadership in these companies?

ROMAN FISHCHUK: Thank

you for this question. It is a big pain point for me right now because unfortunately the companies stopped all of their activities in Ukraine when the war began and all of the enrollment was stopped. Clinical trials that were already approved by the national regulator and local ethics committees, all of them were put on hold. No new trials are coming into the country, no visibilities. I can see the risks for the companies, but I can also say that there are places in Ukraine, where we can do clinical trials, we can provide high quality data for the companies, and we are really encouraging the companies to come to, to resume their work in Ukraine, because right now, clinical trials are needed here more than ever, because that's not only work for us, but that's a very important thing for our patients because, you know, if you have a chronic condition like asthma, COPD or diabetes, you know, this is about quality of life, having less complications. But then for patients with cancer and kidney diseases, those who need dialysis, for some of the patients, access to clinical trials is a matter of their survival. So, we do ask the companies and encourage them to resume their work because there are places where you can do it safely. But don't say that you can do it everywhere, but you can be very selective about the places where you conduct clinical trials. And it's always like that. We sort of compete for clinical trials because we want to be the best. So, the companies choose us and we do encourage the companies to resume our work because there actually is for certain sites we can even perform much better than before because of the migration of the population inside of the country. So ,our city, we had about quarter of a million population before the war and now we're almost 400,000. So you can imagine how our recruitment potential increased with all this internal migration. So yeah, we're just asking the companies to come back to Ukraine and resume your work because this is very needed right now here for the patients in the first place, but also for the hospitals. It's a huge support and it will help the health care system here as well. And again, we are working really hard to be on the same level as other sites globally so we can provide high quality services and do the clinical trials in a high-quality manner.

We wish the war finishes soon, we win this war and we can come back to some sort of normal life. We just want this to finish and continue working in Ukraine and being part of the global community of clinical research.

HANNAH LIPPITT: And that's your dose of Totally Clinical. You can download our podcast on Apple, Spotify and Google. Please subscribe and leave a rating and review so more people can find the show. See you on your next visit and remember to bring your friends. Thanks for listening! Goodbye!