Transcript
Speaker: Welcome to Clinical Data Talks, a podcast brought to you by CRSQ.
Speaker: I'm your host, Sylvain Berteloux.
Speaker: Join me and industry experts as we discuss the latest trends impacting the world of clinical data.
Speaker: As many of you know, I truly care about patients and their journey.
Speaker: That's why I started my patient advocacy podcast a few years ago.
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.
Speaker: A cardiologist by training, Anna has contributed to the evolution of medicine and the healthcare system in Ukraine in many ways.
Speaker: She is now an International Operations Director at Pratyah.
Speaker: Hi Anna, welcome to the podcast and thank you for joining me.
Speaker: Hello, I'm very glad to be here.
Speaker: Thank you for having me.
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.
Speaker: Yes, yeah, and thank you.
Speaker: That's a great introduction to our discussion.
Speaker: So as we know, although everyone plans trials very carefully, no single clinical trial perfectly runs to plan.
Speaker: But today we're talking about situations that completely derail a clinical trial,
Speaker: as you've experienced and unfortunately you're still experiencing in Ukraine.
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?
Speaker: We've got almost 700 active ongoing clinical trials in Ukraine.
Speaker: We've got experience then with more than 1,000 completed clinical trials.
Speaker: Approximately 200 clinical trials were approved each year.
Speaker: We've got almost 3,000 medical institutions and clinical research sites performing clinical trials.
Speaker: And Ukrainian contribution was a 2% to the global clinical trial data worldwide.
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.
Speaker: We've got almost 50 million of population living there.
Speaker: And actually we were famous for this, for having patients, for having doctors, and for having good quality data.
Speaker: Wow, that's impressive.
Speaker: And I'm not sure people are actually aware of those numbers.
Speaker: So when the war started, then considering that you have so many clinical trials ongoing, how did the clinical industry react?
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.
Speaker: And all sponsors and CEOs, they stopped recruiting of new patients for clinical trials.
Speaker: They stopped all of the logistics and all of the activities related to this field, to this part of industry.
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.
Speaker: on the territory of Ukraine, because it was also not possible to have this logistic.
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.
Speaker: You want to go to the chemistry to buy it, not to participate in the clinical trial itself.
Speaker: That was a shock for everyone, for the industry as well.
Speaker: And then smoothly we're starting to adapt the businesses.
Speaker: We're starting to think how we can continue the work in the clinical research.
Speaker: So within Ukraine itself, were you able to keep patients on treatment or did patients not get access to those treatments anymore?
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.
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.
Speaker: So that was, of course, the decision of each person, what is the best for him or for her at that time.
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.
Speaker: Okay.
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.
Speaker: Is that correct?
Speaker: At the beginning it was for the whole country.
Speaker: So the borders were closed.
Speaker: It was any logistics, any transportation on ground because the sky was closed as well.
Speaker: So we were not able to do this.
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.
Speaker: That was the reason why we haven't got any shipments for some period of time.
Speaker: Okay, wow.
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.
Speaker: How did you manage that?
Speaker: You talked about working with the authorities and so on, but there are so many rules that are country specific.
Speaker: So how did you manage to move patient data and physically a patient from Ukraine to a different country?
Speaker: Yes, Opraki is the international site network.
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.
Speaker: That's why we've got this possibility to
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.
Speaker: We were successful in 14 patients' cases.
Speaker: These were patients that were continuing participation in Poland, on our different Polish sites, in different cities here in Poland.
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.
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
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.
Speaker: Also, the main was this language barrier.
Speaker: And it was written in these guidelines, which I mentioned previously, so how we can manage patients, so what can we do?
Speaker: This was also written there, like the rule, that in case of having a certified translator,
Speaker: Together with the patient on the site, it's possible to continue participation in the clinical study.
Speaker: But the person should once again sign ICF to confirm the desire to participate in the clinical trial in the new place.
Speaker: And this was done together with in-person presence of the translator on the site.
Speaker: And each wizard is also accompanied by this translator for the person.
Speaker: If the person is not able to speak and understand Polish language, as in our case was.
Speaker: And the documentation was translated in Ukraine or in Poland.
Speaker: from the Ukrainian language, I mean the primary medical documentation, and also sent the hard copies of it to sites in Poland.
Speaker: Wow, that's a lot of logistics.
Speaker: Were sponsors welcoming those solutions and being able to move patients?
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.
Speaker: management and all of that stuff.
Speaker: It was great.
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.
Speaker: And if you're not in this window,
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.
Speaker: That means that patient is losing forever the possibility to participate.
Speaker: And as usually all of these windows, they're like three, four, five, maybe maximum weeks in different therapeutic areas.
Speaker: That means that we were so shortened in this timeline with quick decisions and from many stakeholders in the process.
Speaker: So not always this was a positive trend.
Speaker: So we've got much more
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.
Speaker: Anyway, we've got some of the cases.
Speaker: Sometimes it was also upset.
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
Speaker: you can imagine shock, stress, everything else.
Speaker: So his parameters became not so good as it should be.
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.
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.
Speaker: But yeah, it was...
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
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
Speaker: unexpected circumstances, unpredictable circumstances, participation of patients and the follow-up visits of such a patient.
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.
Speaker: Hopefully we will not need this anymore, anywhere.
Speaker: Anyway, it should be included.
Speaker: Who knows next and where.
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.
Speaker: Talking about that, so you're talking about what has kind of changed now in protocols to take into account future events.
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?
Speaker: What's the situation now?
Speaker: Yeah, we have a clear upward trend in Ukraine.
Speaker: That's very optimistic.
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.
Speaker: And if to compare even the feedbacks that I hear now, which I heard, for example, in 2022, there,
Speaker: absolutely different.
Speaker: And that's good.
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.
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
Speaker: 60 approximately studies per year approved 2475.
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.
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.
Speaker: And they reopened the recruitment in the studies that were before the war, that were frozen for some period of time.
Speaker: So for now, we have the half of the active studies over the pre-war period.
Speaker: But it's also good.
Speaker: We have the good trends in the number of clinical research sites participating in the clinical studies at the beginning, maybe 23 years.
Speaker: It was 100 clinical research sites involved.
Speaker: Now we have 300.
Speaker: So it's increasing significantly.
Speaker: So we see that people, they adopt themselves.
Speaker: So of course, these are sites on the western part and central part of Ukraine.
Speaker: And we see these medical professionals who moved to other regions in Ukraine, but they're still available and they still have this
Speaker: possibilities, facilities to perform clinical studies in other places on the territory of Ukraine.
Speaker: And it's worth to mention a very good regulatory thing that was done by our Minister of Health of Ukraine.
Speaker: They shortened the approval period of clinical trials to 30 days.
Speaker: And now this is the shortest period in the whole Europe.
Speaker: And this was done intentionally to increase the attractiveness of Ukraine for international sponsors.
Speaker: It's incredible.
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.
Speaker: And actually, that's something I wanted to ask you as well.
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.
Speaker: So do you think it has had an impact on access to innovative treatments in the country?
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
Speaker: such big organizations like UNICEF, Red Cross and many others, they supply drugs on the territory of Ukraine.
Speaker: We've got a very good change in the law also done during the war period about the compassionate usage of the drugs.
Speaker: So, pharma companies, they can continue
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
Speaker: to examine, to monitor the patients, continuing using their drugs after the stop of clinical trial.
Speaker: We've got in Ukraine such a national program as Affordable Medicines, the Stupny League in Ukraine.
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.
Speaker: or with a discount in the chemistry.
Speaker: But overall, it's not enough.
Speaker: And the lack of medications due to these programs, of modern medication, of cutting-edge treatment, of
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
Speaker: diseases and different nosologies that they have.
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.
Speaker: where patients can continue clinical research and clinical care.
Speaker: And moreover, what I observe, many patients, they are internally displaced.
Speaker: So they are coming to the new places.
Speaker: They do not know the medical facilities, doctors who can follow them in their disease.
Speaker: and they are without this constant medical care.
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.
Speaker: But in the majority of cases, people are waiting because they're not in their place.
Speaker: It's not their home.
Speaker: Everything is foreign for them, even on the territory of Ukraine.
Speaker: Clinical trial participation for now even in a higher demand to have
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
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
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.
Speaker: I heard that you have such a clinical study on your site.
Speaker: That's why we
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
Speaker: Yeah.
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.
Speaker: It's this connection that they have with their doctor that they lose and could be quite difficult to actually
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.
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
Speaker: I have one last question for you, Anna.
Speaker: What's the best piece of advice that you've received and that you consistently apply in your work?
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.
Speaker: Patient is in the center of each of our work.
Speaker: But we were taught in such a way, our mindset is built in such a way as doctors that we need to think
Speaker: Firstly, about patient, but honestly, when you're starting your medical practice, it doesn't matter.
Speaker: You're a doctor, you're a research professional, or you're a manager of the medical institution.
Speaker: You're so much overwhelmed by this bureaucracy, papers, protocols, issues and troubles that we're not usually
Speaker: thinking of the priority.
Speaker: We're thinking about patients, but this is one of the things that in our list that we should follow.
Speaker: And this example of our Ukrainian case, and one of them was with the one girl.
Speaker: If I have time, I may briefly tell you about the story of one girl.
Speaker: who had and still has this lymphoma Hodgkin, a 20-year-old young girl from a native city from Harkiv.
Speaker: Before the world was diagnosed, she started her chemotherapy in Ukraine without any positive results at the end.
Speaker: So two years were spent on this treatment.
Speaker: Her condition worsened significantly.
Speaker: She couldn't even move.
Speaker: She lost her job.
Speaker: She just was laying at home.
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.
Speaker: And before the war in November 2021,
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.
Speaker: So she went to Kyiv, she started participation in clinical trial.
Speaker: It was very, very positive with her.
Speaker: results of their blood analysis, she started to feel better.
Speaker: But then the war started and she was informed that unfortunately she cannot participate anymore.
Speaker: Any IMP shipment is not available to Ukraine anymore.
Speaker: So that's the end.
Speaker: So that's the last visit to our site, the last chemotherapy that you can receive.
Speaker: And that's all.
Speaker: And let's wait what will be next.
Speaker: And she was among these patients whom we
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.
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
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.
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.
Speaker: circumstances where we are.
Speaker: That's a wonderful story.
Speaker: Thank you for sharing it.
Speaker: I don't have anything to add to this.
Speaker: Well, thank you, Anna.
Speaker: It's been wonderful talking to you.
Speaker: I really love what you're doing and I love the story you're telling about all the efforts that have gone
Speaker: through to carry on clinical trials in Ukraine and really caring for patients one by one.
Speaker: That's amazing.
Speaker: Thank you.
Speaker: Yeah, I believe that we're speaking about clinical data.
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.
Speaker: And that's actually why we are doing this work.
Speaker: It doesn't matter who you are.
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.
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.
Speaker: and what results we can achieve together with data and real clinical practice.
Speaker: Yeah, fully agree.
Speaker: And thank you all for listening to us.
Speaker: You're probably as moved as I am by this discussion.
Speaker: You can find more episodes of our podcast on the CRS-Cube website.
