Trials with Maya Z

Clinical Trials During War Times in Ukraine
Maya: [00:00:00] Hello everyone. I'm super excited to have today Yuriy with me as one of my first guests to my podcast, Trials with Maya Z. Yuriy is the CEO of Pharmaxi, a clinical research organization based in Ukraine now having an office in Poland. And, he was one of the first people I wanted to invite to this podcast because I wanted for him actually to share with all of us what it's like to run clinical trials in Ukraine prior to the war and after the war. But first, Yuriy, please tell us a little bit more about yourself, about your company.
Yuriy: Oh, thank you Maya, for the introduction , thank you everyone. Thank you for sharing your time with us. I'm Yuriy Lebed, I'm the CEO of Pharmaxi. We were established almost 10 years ago as a Ukrainian company. Now we have all types of services inside our company [00:01:00] to conduct a clinical trial in Ukraine, now Poland and in Eastern Europe. So we have everything from medical writing to data management, and statistical, , expertise. It's good to to be with you here today and to speak about the clinical research market prior to the war and to speak a little bit about the current situation.
Maya: Thanks, Yuriy, when mentioning the market, I decided to check what it was like running a clinical trial in Ukraine prior to the war, and I just saw briefly some stats that really amazed me. I always knew that Ukraine is one of the top recruiting countries, but I didn't know that from the entire world, it's number 8 on numbers of people recruited in clinical trials, which is incredible.
Can you share with us what it was like to run a clinical trial in Ukraine prior to starting the war? [00:02:00]
Yuriy: Oh, thank you. That's a very good question. And I can say that maybe it is surprising, but for us, it's not a big surprise because we know that Ukraine historically is a very good country for clinical trials, basically because of early adoption of the GCP standard. It occurred almost 20 years ago.
So, legislation has been harmonized with European and US legislation. And from this time, we have started to train investigators to learn more about best practices. Many CROs established their offices here in Ukraine. They were successful because enrollment rate historically is much higher than in other European countries. This fact [00:03:00] attracts a lot of customers and sponsors to initiate clinical trials here. Even big pharmaceutical companies established here, big research units to manage clinical trials.
I would say that we have the three most important factors for why we are some kind of leading country in terms of recruitment and quality. The first factor is that Ukraine is a big country. It was 40 million. Now it is maybe 35 million or 30 million, but it's quite a big number of citizens.
And then we have a centralized healthcare system. When we have a network of small hospitals, which are linked with big regional hospitals, and very high number of patients, who visit that clinic. It is a big [00:04:00] resource for screening patients in order to find proper patients to be included in a clinical trial. It's like a constant flow of patients and investigators can evaluate if this patient is valid for a particular clinical trial or not. The third factor of success is that in Ukraine the average salary for a doctor is not very high. It's not as high as in Europe, it's not as good as in the USA.
Investigators are actively involved in this process. They try to be efficient. They try to create their own referral networks. They maintain these referral networks between different investigators and when a trial is initiated in the hospital, then this investigator sometimes is called [00:05:00] by different investigators and they say, "Oh, I have this patient for you."
It's also maintained on some autonomic level, no one invests in these networks. But investigators try to develop and maintain them because it is a good resource for their monthly income and some addition to their salary. They are very motivated to be efficient and to provide data in a good quality and on timely manner.
In the end, we've had many FDA and EMA inspections and audits of top recruiting study sites, and they've been really successful. So, these are the three important factors and we have an additional factor too, which is non- global coverage of insurance for patients. So [00:06:00] patients are also motivated to be involved in clinical trials because it gives them free medication, diagnostic procedures, and other benefits.
Maya: So, if I am to summarize, a big portion of the success of Ukraine in clinical research is the fact that it's a big country with big population, and this population is very eager to get access to new sorts of treatments. And clinical trials are their only way. These people being organized in a centralized system, concrete hospitals, the big hospitals, but also these regional hospitals provide the investigators with easy access to these patients.
But one thing that really surprised me here, I have to say, is the fact that these investigators have organized an internal system where they even suggest to each other different patients so that they can support each other. And I remember my early days in clinical research, maybe 15 years ago, [00:07:00] I remember how much we were discussing with different stakeholders, how we can build referral programs, and they never worked among doctors, but I can see that this organically somehow happened in Ukraine, which is great. Okay, so, yeah, again, before we started, the conversation, I also checked, how many clinical trials were ongoing in Ukraine when the war started and I remember, if I'm not mistaken, it was around 600 clinical trials, so a big number. What happened afterwards?
Yuriy: Oh, then we had big problems. And in the first three or four weeks, it was complete destruction. No one knew what happened. And investigators weren't really willing to speak with us about clinical trials because their main motivation and main fear was about their physical safety and their family's safety. [00:08:00]
In one or two months we discovered that investigators wanted to talk about ongoing trials, but they didn't want to talk about the new ones. Six months later when they checked and when they knew that Pharmaxi is the only company which initiates new trials and submits new trials, they started calling us constantly and saying, “We can see that you are the only company which adjusted to this situation. Please, keep our center in mind to get involved in your projects and your clinical trials. I would say that in our newly started clinical trials, we have a very good enrollment rate, and it was a big surprise for us. It was not self-evident, but due to the absence of [00:09:00] internal competition inside the hospital, inside the study site, all patients, who are available, enrolled in our clinical studies and this gives us even much better dynamics than before the war, surprisingly.
Maya: Yeah, I was going to ask you exactly that, because you were the person behind the first clinical trial after the war and I'm very excited to learn what it's like to run a clinical trial during war times. You mentioned four factors for why Ukraine is successful in clinical research.
Are these factors still relevant or maybe are there other factors making Ukraine successful in clinical trials?
Yuriy: In general, I think that those factors are still relevant. Yes, we've lost some population due to immigration during the first several months, and we lost millions. It's true. [00:10:00] But, in the end, we are more than 30 million people here in Ukraine. It remains quite a good number. Also, the centralized healthcare system works as always. And the main motivation to be involved in clinical trials for investigators and patients, they became even bigger.
Maya: Even bigger.
Yuriy: Even better. Yes, because very famous and productive clinical sites before the war have been somehow relaxed by multiple projects.
So, we have enough patients, we have a big number of ongoing trials. They are not really motivated, and they can choose between one study or another study. They can say, "Oh, this investigator fee is not so big. Please, find another study site." So, some issues [00:11:00] have been linked with this big number of trials, but now everyone is motivated. They say, "Okay, we are ready to be involved for the less investigator fee per patient." Especially, if we talk about rare disease or diseases with very big competition between clinical trials.
Now we have these patients who are actively looking for clinical trials. They try to find this trial and once you would have 7-10,000 euros just finding fee for this trial. And now we have patients who are looking for Crohn disease, for example, or hemophilia study.
They are looking for this project that will not cost some thousands anymore.
Maya: [00:12:00] I guess the sad side of the things is that these people will be even more incentivized by the fact that the clinical trial provides even more support and more care. Because when you are in a clinical trial, you must be monitored sometimes 24 hours, and that might provide them with an additional motivation for them to be a part of a clinical trial.
Since the healthcare system might be challenged in one way or another. So, what are the new challenges in running a clinical trial nowadays in Ukraine?
Yuriy: I think that maybe the big challenge is to speak with sponsors on this phase. It is the biggest challenge, because people see through the TV or other media that all Ukraine is constantly bombed, and it is at a very high risk. And this picture is somehow corrupted or a not very clear reflection of [00:13:00] what we have here right now, if we talk about Kyiv and the western region, central Ukraine. Maybe if you are here, you will know. You will not notice any sign of the war. Supermarkets are full, streets are crowded, traffic jams every evening.
And the restaurants are open, so it's very close to normal life. Maybe we have some problems with electricity from time to time. It is the only challenge, but hospitals and institutions are now equipped with, with diesel generator and alternative power supply.
So now this factor is eliminated. The biggest problem now is to speak with sponsor and to say that the real war is 600 kilometers [00:14:00] from the capital of Ukraine.
Maya: Hmm. When customers and sponsors ask me, "Okay, do you see any risks in clinical trials when you live in Kyiv? I answer them, "Guys, in this flat, I live with my family, with my daughter and I do not try to send them out somewhere in Europe or in Germany or somewhere. I live with that here and maybe this is the best evidence that I consider this risk of physical damage is very low.
Yeah, I think we discussed that in previous calls. You lived for a while outside of Kyiv and then suddenly your daughter felt, [00:15:00] "Oh, maybe it's better to go back, daddy, I want to have my room back. " And you decided to go back and once you were at home, you really felt at home and secure. Does that mean that you don't need to think about any extra measures when it comes to patient safety or maybe the data safety?
Yuriy: I think that we must think about even the small chance of data damage. We have our own EDC system and, for example, the servers for this system are in, Frankfurt, Germany, so no risks for data safety in this regard. Also, we store our documents in a cloud storage.
It could be a OneDrive cloud storage, or a Google Drive. All those storages are completely [00:16:00] safe. One of the measures is to store primary documentation and scans on these cloud storages. We try to update electronic systems with patient data as fast as possible, to not keep it in paper format and those are mitigation factors or activities to guarantee that data is completely safe. For example, now we speak with you via Sterling, so it is also a risk mitigating strategy and action to stay online no matter what.
Maya: Yeah, that's great. And what about startup timelines? What was it like when you submitted the first clinical trial to the ethics committee and to the local institutions?
Yuriy: [00:17:00] Yeah. If Pharmaxi is the only company which submits clinical trials, it could be maybe within several days. There was some bureaucratic procedure, and the State Expert Center evaluated our documents for one week. Then, it was really fast because we have a fast line for COVID-19 trials and this trial has been approved within 10 days.
Can you imagine? 10 days.
Maya: No, I can't imagine, but wow.
Yuriy: Yeah, it's incredible. It's not 60 days, it's not 90 days. I have had the hope that it could be really fast, but I never expected that it will be so fast. But now we have timelines for COVID-19 [00:18:00] trials, so we can spend 7-10 days for the approval procedure.
It's really fast. We have several approvals for COVID-19 trials. I think that other projects will also move really fast, because additional advantage of this time is that big CROs are just continuing ongoing clinical trials. They did not initiate any new trials, because these, these big companies did not decide how to act in these circumstances. But the law on regulatory agency is quite low. Once other companies decided to restart activities here, we have a good benefit as a [00:19:00] very fast-acting company and country.
Maya: Well, I hope, Yuriy, that many people, representatives of companies, who are going to hear this conversation and will feel a little bit more comfortable exploring again Ukraine as a clinical trials destination. I'm personally convinced of all the factors that you mentioned that make Ukraine a really good country for clinical trials and, from what I see, you've already managed the situation and you moved on.
Generally speaking, COVID-19, the war in Ukraine, these are all factors that really had to shake us a little bit and start thinking about the clinical trials maybe in a different way. But if I have to summarize from what I've seen so far, it's all in the right direction to be more flexible, to customize our approach.
And if there are more companies like yours, Yuriy, to be able to really change their [00:20:00] strategy accordingly, I think that we will all be successful. So, any last words that you want to share with us, Yuriy, before we end up this episode?
Yuriy: Yeah. First of all, I would like to thank you, Maya, for this conversation and for your belief in Ukraine, and your passion for clinical trials. I feel this light from your eyes when you talk about clinical trials. I wish you all the best in your journey.
Maya: Same to you, Yuriy. Thank you very much for this conversation. I hope more people connect with Yuriy and learn more about Ukraine now. Thank you, Yuriy, once again.