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Beyond the data: Human stories from clinical trials in Ukraine
16 Plays3 months ago
In this final episode of season 2, Sylvain Berthelot welcomes Anna Titkova, who shares her first-hand experience of running clinical trials in Ukraine before and during the conflict. In 2022, Anna lived in Ukraine and acted as the country head for Pratia, a research site network.
Anna describes how Ukraine, once a thriving hub for international clinical research, was suddenly forced to adapt to unprecedented challenges. From halting patient recruitment and struggling with the shipment of investigational medicines, to relocating vulnerable oncology patients across borders, she paints a vivid picture of resilience and resourcefulness under pressure.
Together, Sylvain and Anna discuss the rapid regulatory adaptations that allowed continuity of care, the growing demand for clinical trial participation among internally displaced persons, and the remarkable story of a young patient whose treatment continued thanks to cross-border collaboration.
Tune in to hear how clinical trials in Ukraine have not only survived but are resurging, and why patient trust, unity, and human-centered approaches are shaping the future of research in the region.
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Transcript
Introduction to Clinical Data Talks Podcast
00:00:14
Speaker
Welcome to Clinical Data Talks, a podcast brought to you by CRSQ.
00:00:19
Speaker
I'm your host, Sylvain Berteloux.
00:00:21
Speaker
Join me and industry experts as we discuss the latest trends impacting the world of clinical data.
00:00:28
Speaker
As many of you know, I truly care about patients and their journey.
00:00:33
Speaker
That's why I started my patient advocacy podcast a few years ago.
Meet Anna Titkova: Role & Advocacy
00:00:38
Speaker
And that's also why I'm very excited and honored to welcome Anna Titkova to the podcast, as we are going to discuss what true patient care looks like.
00:00:50
Speaker
A cardiologist by training, Anna has contributed to the evolution of medicine and the healthcare system in Ukraine in many ways.
00:01:01
Speaker
She is now an International Operations Director at Pratyah.
00:01:07
Speaker
Hi Anna, welcome to the podcast and thank you for joining me.
00:01:13
Speaker
Hello, I'm very glad to be here.
00:01:15
Speaker
Thank you for having me.
00:01:17
Speaker
It's a great honor to share my expertise, to share my experience in the clinical research field together with my participation in patients' advocacy activities and involvement in patients' relocation from Ukraine to Poland and their life during this period of time in Ukraine.
00:01:41
Speaker
Yes, yeah, and thank you.
00:01:43
Speaker
That's a great introduction to our discussion.
00:01:49
Speaker
So as we know, although everyone plans trials very carefully, no single clinical trial perfectly runs to plan.
Ukraine's Pre-War Clinical Trials Environment
00:02:02
Speaker
But today we're talking about situations that completely derail a clinical trial,
00:02:08
Speaker
as you've experienced and unfortunately you're still experiencing in Ukraine.
00:02:16
Speaker
Before we go into the journey you've been through, could you share with us what the clinical trial landscape was like in Ukraine before the conflict started in 2022?
00:02:29
Speaker
We've got almost 700 active ongoing clinical trials in Ukraine.
00:02:34
Speaker
We've got experience then with more than 1,000 completed clinical trials.
00:02:39
Speaker
Approximately 200 clinical trials were approved each year.
00:02:43
Speaker
We've got almost 3,000 medical institutions and clinical research sites performing clinical trials.
00:02:52
Speaker
And Ukrainian contribution was a 2% to the global clinical trial data worldwide.
00:02:58
Speaker
So that was actually a very good place with a big population because you know that Ukraine is a big country if you compare with many countries in Europe.
00:03:10
Speaker
We've got almost 50 million of population living there.
00:03:14
Speaker
And actually we were famous for this, for having patients, for having doctors, and for having good quality data.
00:03:24
Speaker
Wow, that's impressive.
00:03:27
Speaker
And I'm not sure people are actually aware of those numbers.
00:03:32
Speaker
So when the war started, then considering that you have so many clinical trials ongoing, how did the clinical industry react?
Impact of War on Clinical Trials in Ukraine
00:03:46
Speaker
Clinical industry reacted immediately, probably together with the first bomb that we read at 4.45am in the morning of the 24th of February 2022.
00:03:58
Speaker
And all sponsors and CEOs, they stopped recruiting of new patients for clinical trials.
00:04:05
Speaker
They stopped all of the logistics and all of the activities related to this field, to this part of industry.
00:04:14
Speaker
The main problem was also for us for the next few months, even half of the year, the shipment of IMP, the shipment of even registered drugs.
00:04:25
Speaker
on the territory of Ukraine, because it was also not possible to have this logistic.
00:04:30
Speaker
It was not established for some period of time, and people on the territory of Ukraine, they were suffering from the lack of medications.
00:04:39
Speaker
You want to go to the chemistry to buy it, not to participate in the clinical trial itself.
00:04:48
Speaker
That was a shock for everyone, for the industry as well.
00:04:51
Speaker
And then smoothly we're starting to adapt the businesses.
00:04:56
Speaker
We're starting to think how we can continue the work in the clinical research.
00:05:02
Speaker
So within Ukraine itself, were you able to keep patients on treatment or did patients not get access to those treatments anymore?
Challenges of Patient Relocation Within Ukraine
00:05:15
Speaker
So some of the patients, they were relocated inside Ukraine, so mostly from the eastern part of Ukraine to the western part of Ukraine to the southern side on the west.
00:05:27
Speaker
Some of the patients, they refused to continue because it was also dangerous even to go outside from their homes or they decided to stay in their homes and their flats, houses in the eastern part of Ukraine where sites were not active to continue clinical trials.
00:05:44
Speaker
So that was, of course, the decision of each person, what is the best for him or for her at that time.
00:05:52
Speaker
But we've got these statistics, even I cannot probably say it quickly, the numbers, but we have not only externally relocated patients, but internally as well.
00:06:02
Speaker
Okay.
00:06:03
Speaker
And so that means that because you described a situation where it was even difficult to receive IMP, but that was to the eastern part of Ukraine rather than the whole country.
00:06:16
Speaker
Is that correct?
00:06:17
Speaker
At the beginning it was for the whole country.
00:06:20
Speaker
So the borders were closed.
00:06:21
Speaker
It was any logistics, any transportation on ground because the sky was closed as well.
00:06:28
Speaker
So we were not able to do this.
00:06:33
Speaker
And it's the risk even for a person who will do this, who will transfer the medication through Ukraine from the border, from Polish border, from Hungarian border.
00:06:44
Speaker
That was the reason why we haven't got any shipments for some period of time.
00:06:51
Speaker
Okay, wow.
00:06:53
Speaker
And I've heard of patients moving from site to site within one country, but I don't think I've ever experienced moving a patient from a site in Ukraine to a site in a different country.
Cross-Border Clinical Trial Participation
00:07:08
Speaker
How did you manage that?
00:07:11
Speaker
You talked about working with the authorities and so on, but there are so many rules that are country specific.
00:07:19
Speaker
So how did you manage to move patient data and physically a patient from Ukraine to a different country?
00:07:29
Speaker
Yes, Opraki is the international site network.
00:07:31
Speaker
So we are a company that has sites in eight European countries, and this might be our own clinical research sites or embedded research sites or clinical research units established on the base of some state or big private medical facilities.
00:07:49
Speaker
That's why we've got this possibility to
00:07:53
Speaker
communicate with people from different countries and speaking about the trials that we can find to the same trial because it would be the same, exactly the same study of what the patients from Ukraine to somewhere in our countries where we are.
00:08:08
Speaker
We were successful in 14 patients' cases.
00:08:11
Speaker
These were patients that were continuing participation in Poland, on our different Polish sites, in different cities here in Poland.
00:08:21
Speaker
And they did it with the communication, not only authorities, but the sponsor and CROs, or sponsor if it was direct to sponsor clinical research and with the governance of the sponsor.
00:08:35
Speaker
all of these stages of clinical study because this was their approval to share data, to share the ID number of the patient with the data that was in the electronic data systems and from which the
00:08:52
Speaker
doctor from another site in another country can open and have the access to the data previously done by his colleague on the territory of Ukraine.
00:09:03
Speaker
Also, the main was this language barrier.
00:09:07
Speaker
And it was written in these guidelines, which I mentioned previously, so how we can manage patients, so what can we do?
00:09:14
Speaker
This was also written there, like the rule, that in case of having a certified translator,
00:09:20
Speaker
Together with the patient on the site, it's possible to continue participation in the clinical study.
00:09:25
Speaker
But the person should once again sign ICF to confirm the desire to participate in the clinical trial in the new place.
00:09:35
Speaker
And this was done together with in-person presence of the translator on the site.
00:09:41
Speaker
And each wizard is also accompanied by this translator for the person.
00:09:46
Speaker
If the person is not able to speak and understand Polish language, as in our case was.
00:09:53
Speaker
And the documentation was translated in Ukraine or in Poland.
00:10:00
Speaker
from the Ukrainian language, I mean the primary medical documentation, and also sent the hard copies of it to sites in Poland.
00:10:12
Speaker
Wow, that's a lot of logistics.
00:10:15
Speaker
Were sponsors welcoming those solutions and being able to move patients?
00:10:22
Speaker
Because it's very important and I'm sure sponsors see the benefit of keeping patients in treatment, but at the same time, logistically, it sounds quite difficult.
00:10:32
Speaker
management and all of that stuff.
00:10:35
Speaker
It was great.
00:10:37
Speaker
Not everyone, let's say not everyone was so quick because we have a short and timelines, you know, that it is so have the windows for the next visit.
00:10:46
Speaker
And if you're not in this window,
00:10:48
Speaker
That means that you are losing the patient and almost in 100% of cases this person is not able to restart from the visit zero, the same clinical study.
00:10:59
Speaker
That means that patient is losing forever the possibility to participate.
00:11:05
Speaker
And as usually all of these windows, they're like three, four, five, maybe maximum weeks in different therapeutic areas.
00:11:13
Speaker
That means that we were so shortened in this timeline with quick decisions and from many stakeholders in the process.
00:11:23
Speaker
So not always this was a positive trend.
00:11:25
Speaker
So we've got much more
00:11:28
Speaker
We request much more people, patients who would like to continue, but due to some of these reasons, due to some misunderstanding, some of these risk management things, we haven't got this possibility to relocate them and to work in the clinical research.
00:11:48
Speaker
Anyway, we've got some of the cases.
00:11:50
Speaker
Sometimes it was also upset.
00:11:55
Speaker
Then we made all of these things and the patient was transferred, the documentation was transferred and the patient was coming to the next visit and due to
00:12:04
Speaker
you can imagine shock, stress, everything else.
00:12:06
Speaker
So his parameters became not so good as it should be.
00:12:10
Speaker
And the patient couldn't be involved in the clinical study due to some inclusion-exclusion criteria, but previously they were okay, but due to obvious reasons.
00:12:20
Speaker
And we were fighting for this as well, trying to convince the sponsor that it's due to the obvious reasons, let's give the chance, let's make the possibility.
00:12:30
Speaker
But yeah, it was...
00:12:32
Speaker
said no and we've got such disappointed and negative results as well when a lot of work was done but at the end the patient was not submitted to participate in the clinical trial so we've got happy ends we've got some
00:12:48
Speaker
not so optimistic outcomes but anyway it was a good experience to to follow and even i may tell you that after some of the period of time many sponsors and heroes they are starting to include in their protocols in their some of their guidelines uh things regarding the
00:13:12
Speaker
unexpected circumstances, unpredictable circumstances, participation of patients and the follow-up visits of such a patient.
Post-War Revival of Clinical Trials in Ukraine
00:13:20
Speaker
In the clinical trial in Ukraine was a case study for them to think and to include such case in their documents, in their procedures.
00:13:34
Speaker
Hopefully we will not need this anymore, anywhere.
00:13:38
Speaker
Anyway, it should be included.
00:13:40
Speaker
Who knows next and where.
00:13:44
Speaker
It's good to see that the industry is learning from those cases that unfortunately for those individuals they couldn't carry on in the trial but still it's a learning.
00:14:00
Speaker
Talking about that, so you're talking about what has kind of changed now in protocols to take into account future events.
00:14:12
Speaker
But thinking about Ukraine specifically, have you seen an evolution over the past maybe year or 18 months in the execution of clinical trials?
00:14:27
Speaker
What's the situation now?
00:14:29
Speaker
Yeah, we have a clear upward trend in Ukraine.
00:14:34
Speaker
That's very optimistic.
00:14:36
Speaker
And if I compare, because I started this, my activities with patients, with promoting once again Ukraine and saying that this is really a place where we can do, where we want to do clinical trials.
00:14:48
Speaker
And if to compare even the feedbacks that I hear now, which I heard, for example, in 2022, there,
00:14:57
Speaker
absolutely different.
00:14:59
Speaker
And that's good.
00:15:00
Speaker
That's good that we managed to change, to prove to sponsors to the world that this industry can exist even in such circumstances as we have on the territory of Ukraine.
00:15:14
Speaker
If we take some numbers, for example, the new approvals of new clinical trials in 2022, probably it was fewer of them in the end of the year, 23
00:15:25
Speaker
60 approximately studies per year approved 2475.
00:15:31
Speaker
And this year I saw the numbers, it's almost the same 70 something clinical studies approved during the first half of the year.
00:15:41
Speaker
So we have all, if I'm not mistaken, 400 active clinical studies altogether because they restarted the operations on the territory of Ukraine, big companies like Ilili, AstraZeneca, Merck.
00:15:54
Speaker
And they reopened the recruitment in the studies that were before the war, that were frozen for some period of time.
00:16:02
Speaker
So for now, we have the half of the active studies over the pre-war period.
00:16:08
Speaker
But it's also good.
00:16:09
Speaker
We have the good trends in the number of clinical research sites participating in the clinical studies at the beginning, maybe 23 years.
00:16:17
Speaker
It was 100 clinical research sites involved.
00:16:22
Speaker
Now we have 300.
00:16:24
Speaker
So it's increasing significantly.
00:16:28
Speaker
So we see that people, they adopt themselves.
00:16:30
Speaker
So of course, these are sites on the western part and central part of Ukraine.
00:16:35
Speaker
And we see these medical professionals who moved to other regions in Ukraine, but they're still available and they still have this
00:16:45
Speaker
possibilities, facilities to perform clinical studies in other places on the territory of Ukraine.
00:16:53
Speaker
And it's worth to mention a very good regulatory thing that was done by our Minister of Health of Ukraine.
00:17:01
Speaker
They shortened the approval period of clinical trials to 30 days.
00:17:05
Speaker
And now this is the shortest period in the whole Europe.
00:17:09
Speaker
And this was done intentionally to increase the attractiveness of Ukraine for international sponsors.
00:17:17
Speaker
It's incredible.
00:17:18
Speaker
It's amazing to see how it's adapted actually and how the regulatory bodies in Ukraine have adapted so much that it makes the country still appealing to run clinical trials.
00:17:36
Speaker
And actually, that's something I wanted to ask you as well.
00:17:42
Speaker
Clinical trials don't apply to everyone, but for the people who it applies to, it's a way of getting access to innovative treatments, treatments that might be better for them than what's already on the market.
00:18:03
Speaker
So do you think it has had an impact on access to innovative treatments in the country?
Importance of Clinical Trials for Drug Access in Ukraine
00:18:12
Speaker
uh we uh some some humanitarian aids some programs of donations of the drugs to ukraine that's probably was the main source of medication especially during the first year of war thanks to our international support companies all around the world we receive this medication we have some uh humanitarian procurement so when
00:18:37
Speaker
such big organizations like UNICEF, Red Cross and many others, they supply drugs on the territory of Ukraine.
00:18:45
Speaker
We've got a very good change in the law also done during the war period about the compassionate usage of the drugs.
00:18:56
Speaker
So, pharma companies, they can continue
00:19:00
Speaker
treatment of patients on the territory of ukraine even when the stage two or three of clinical study has finished but the drug was not registered yet on the territory of ukraine it's also allowed and i saw recently a high interest from sponsors regarding this point that they need such places where they can continue
00:19:22
Speaker
to examine, to monitor the patients, continuing using their drugs after the stop of clinical trial.
00:19:30
Speaker
We've got in Ukraine such a national program as Affordable Medicines, the Stupny League in Ukraine.
00:19:37
Speaker
So it's like a list of drugs, mostly for chronic diseases, and the patient has a prescription from his family doctor or specialist, can get some of the medication for free.
00:19:50
Speaker
or with a discount in the chemistry.
00:19:53
Speaker
But overall, it's not enough.
00:19:55
Speaker
And the lack of medications due to these programs, of modern medication, of cutting-edge treatment, of
00:20:06
Speaker
some drugs that can be helpful for people with specific diagnosis, with comorbidities, because it's also important for them to combine the medication that can work on different
00:20:25
Speaker
diseases and different nosologies that they have.
00:20:28
Speaker
That's why for today, these clinical trials is really a place, the only one place, due to this limitation in the volume, in the amount of drugs that are on the market in Ukraine.
00:20:40
Speaker
where patients can continue clinical research and clinical care.
00:20:44
Speaker
And moreover, what I observe, many patients, they are internally displaced.
00:20:49
Speaker
So they are coming to the new places.
00:20:51
Speaker
They do not know the medical facilities, doctors who can follow them in their disease.
00:20:59
Speaker
and they are without this constant medical care.
00:21:03
Speaker
So, yeah, of course, if it's urgent, the person will go to the hospital, definitely will get the treatment, surgery or something like that.
00:21:11
Speaker
But in the majority of cases, people are waiting because they're not in their place.
00:21:16
Speaker
It's not their home.
00:21:17
Speaker
Everything is foreign for them, even on the territory of Ukraine.
00:21:21
Speaker
Clinical trial participation for now even in a higher demand to have
00:21:27
Speaker
to be together with doctor to be uh to be confident that you're under observation that you will be monitoring you will have this proper analysis done you will be uh consulted in case of some changes and we see in the clinical trials that we have already started in ukraine how big
00:21:49
Speaker
uh interest is even to compare with for example 2020 2021 when patients always are thinking okay this experiment maybe i do not need to go there i do not know what they are investigating what they are examining there but now i haven't heard such so even when we one person started this participation it's like they
00:22:12
Speaker
the relatives, all of the people who know him, they're sending this world of mouse information and we hear a new patient is calling to us saying, I would like as well to come to you to participate.
00:22:24
Speaker
I heard that you have such a clinical study on your site.
00:22:28
Speaker
That's why we
00:22:30
Speaker
we see this and uh we're speaking about it today and sending this message to sponsors to cros that actually uh we have what you need patients and doctors willing to participate
00:22:45
Speaker
Yeah.
00:22:47
Speaker
And I think you raised a very good point that for a patient moving from a site to another, it's not just moving any clinical records or so on.
00:23:01
Speaker
It's this connection that they have with their doctor that they lose and could be quite difficult to actually
00:23:08
Speaker
find someone who like from the site staff who will advocate for them to be part of a clinical trial because they don't necessarily know their condition, they don't necessarily know their medical history as well.
00:23:25
Speaker
um well that's a lot to to think about but i'm glad you you raised this uh this appeal to to the community out there because i agree with you that um it's good to to bring treatments everywhere uh especially when you have doctors and patients who want to take part in clinical trials
00:23:48
Speaker
I have one last question for you, Anna.
00:23:52
Speaker
What's the best piece of advice that you've received and that you consistently apply in your work?
00:24:02
Speaker
If to speak about and to think about the advice that I can apply to my work, perhaps it was the first one from my first days in medical university when we were saying that patient is the first.
Patient Stories: Resilience Amidst War
00:24:15
Speaker
Patient is in the center of each of our work.
00:24:18
Speaker
But we were taught in such a way, our mindset is built in such a way as doctors that we need to think
00:24:25
Speaker
Firstly, about patient, but honestly, when you're starting your medical practice, it doesn't matter.
00:24:30
Speaker
You're a doctor, you're a research professional, or you're a manager of the medical institution.
00:24:36
Speaker
You're so much overwhelmed by this bureaucracy, papers, protocols, issues and troubles that we're not usually
00:24:47
Speaker
thinking of the priority.
00:24:49
Speaker
We're thinking about patients, but this is one of the things that in our list that we should follow.
00:24:58
Speaker
And this example of our Ukrainian case, and one of them was with the one girl.
00:25:04
Speaker
If I have time, I may briefly tell you about the story of one girl.
00:25:09
Speaker
who had and still has this lymphoma Hodgkin, a 20-year-old young girl from a native city from Harkiv.
00:25:17
Speaker
Before the world was diagnosed, she started her chemotherapy in Ukraine without any positive results at the end.
00:25:26
Speaker
So two years were spent on this treatment.
00:25:28
Speaker
Her condition worsened significantly.
00:25:31
Speaker
She couldn't even move.
00:25:32
Speaker
She lost her job.
00:25:34
Speaker
She just was laying at home.
00:25:36
Speaker
And the doctor said that there is any available option on Ukraine, the territory of Ukraine, with the registered drugs that can help her.
00:25:45
Speaker
And before the war in November 2021,
00:25:48
Speaker
The doctor called her and said that there is one clinical trial in Kyiv where you may try to participate because it's according to your condition that you have.
00:25:58
Speaker
So she went to Kyiv, she started participation in clinical trial.
00:26:02
Speaker
It was very, very positive with her.
00:26:08
Speaker
results of their blood analysis, she started to feel better.
00:26:11
Speaker
But then the war started and she was informed that unfortunately she cannot participate anymore.
00:26:18
Speaker
Any IMP shipment is not available to Ukraine anymore.
00:26:21
Speaker
So that's the end.
00:26:23
Speaker
So that's the last visit to our site, the last chemotherapy that you can receive.
00:26:28
Speaker
And that's all.
00:26:30
Speaker
And let's wait what will be next.
00:26:32
Speaker
And she was among these patients whom we
00:26:35
Speaker
relocated to Poland and you can imagine this speed because her next visit should be in the middle of March, so in two weeks, two and a half weeks after the full-scale invasion, but we were successful.
00:26:51
Speaker
story with a happy end so she was transferred to poland to our site in krakow she received this proper medication for the next week that were performed on the territory of poland and she she's still in this clinical study with in a good physical condition she has a new work here and a new love even here in poland and that's that's how it is so that's what does it mean to have this patient's centricity to put your patient first
00:27:19
Speaker
And this experience reinforced the lesson I have been told, that all the protocols can be adopted, logistics sold, data collection adjusted, but if you lose the patient's trust, you lose the whole clinical trial.
00:27:35
Speaker
And this is just a reason why we're able to continue our work and why patients still believe in us and put their trust in clinical trials, even such a challenging.
00:27:48
Speaker
circumstances where we are.
00:27:52
Speaker
That's a wonderful story.
00:27:55
Speaker
Thank you for sharing it.
00:27:57
Speaker
I don't have anything to add to this.
00:28:01
Speaker
Well, thank you, Anna.
00:28:02
Speaker
It's been wonderful talking to you.
00:28:07
Speaker
I really love what you're doing and I love the story you're telling about all the efforts that have gone
00:28:15
Speaker
through to carry on clinical trials in Ukraine and really caring for patients one by one.
00:28:25
Speaker
That's amazing.
00:28:26
Speaker
Thank you.
Conclusion: Unity in Advancing Patient Care
00:28:27
Speaker
Yeah, I believe that we're speaking about clinical data.
00:28:31
Speaker
It's important, but with each clinical data we have life, we have hope, we have belief, and we have patients who believe in us, who trust us, who trust this data to us.
00:28:44
Speaker
And that's actually why we are doing this work.
00:28:46
Speaker
It doesn't matter who you are.
00:28:49
Speaker
A person working with clinical data, with numbers, or a person dealing with a patient on a clinical research site, that's the same process, it's the same world in which we live, in which we need to support each other.
00:29:03
Speaker
And actually we see, passing such an example, unfortunately, that we have in Ukraine, but it teaches a lot how united we can be.
00:29:14
Speaker
and what results we can achieve together with data and real clinical practice.
00:29:22
Speaker
Yeah, fully agree.
00:29:25
Speaker
And thank you all for listening to us.
00:29:27
Speaker
You're probably as moved as I am by this discussion.
00:29:31
Speaker
You can find more episodes of our podcast on the CRS-Cube website.