Trials with Maya Z

Hello, and welcome to the next episode of Trials with Maya Z, brought to you by TrialHub, a data intelligence platform that helps clinical research organizations and sponsors plan clinical trials. This podcast is about how we can make clinical trials more successful and patient-friendly. Friendly, I am your host Maya C and in every episode, I will be interviewing a leading expert from various industries in order to discuss some of the major challenges and brainstorm how we can solve them.

Let's get started.

 Hello everyone and welcome again to Trials with Maya Z this is your host, Maya speaking here. And I have a very interesting guest, a friend of mine actually- David Rosenbaum. He's here with us today to share an incredible story and very powerful message, that can help us improve our decision-making and way of thinking about clinical trials and are these clinical trials actually inclusive.

We will speak about immigrants in clinical trials. David is the founder of uh, Rosenbaum Group, a clinical research organization with experience throughout Europe by conducting clinical trials throughout Europe and main focus on the Southeastern Balkans. David, welcome. And yeah, please, give us a little bit more background about yourself and yeah, what you do today.

Thank you, Maya. Thank you for having the chance of talking to you and discussing the issue today. So as you said, we are friends and have been also previously working with you. And, yeah, since 2019, I started to conduct things in my own way, and this led to creation of our own CRO. Mainly at the moment, we are subcontractors for bigger CROs, and we are focusing, as you mentioned, to the Southeastern Balkans and Turkey.

So our prime countries of operations are Albania, Greece, and Turkey, and, sporadically, we also support Slovakia, the Czech Republic, and Germany. So, yeah, as you mentioned today, we'll have a very interesting topic to discuss.

Yes, indeed. So last time we spoke, David, you actually told me a story, that surprised me completely. And I've been working in the clinical research space for many years, but this is something that I never came across. And I was very eager to bring the attention of my audience to this topic.

And again, it's about immigrants and clinical trials. So David, you told me about this story where you tried, you're fighting actually for allowing immigrants that are eligible for a certain clinical trial to be part of the clinical trial. But you're fighting, like fight is a very good word. So why don't you first start by telling us the story?

So, yes, this is a topic that has to have a broader audience, in my opinion. So the whole situation. Or the whole focus is falling on Turkey. As you may be aware, Turkey is a country of 70 million, inhabitants, and there are a lot of minorities, but also a lot of communities who are not of Turkish descent.

Yes. So. There are people who are long term working in Turkey. , and, this brings us a huge diversity in the patient, pool a couple of our investigators, had the idea to enroll patients who are not Turkish. Okay. So, for example, in Turkey, you have a large minority of people from Iraq, and Syria, but there are also seasonal workers, for example, from Azerbaijan, and Uzbekistan.

There are also a lot of English-speaking people living in Turkey, people from Libya. So, it is really a beautiful mix. And, this also gives an opportunity to have a good, patient mix when it comes to the data collection. However, when we tried to consider this patient population, to be included in the study, based on the suggestions from our investigators.

We have performed an initial request to the authorities, so to the TMMDA, the Turkish Medicine and Medical Device Agency, and also the centretics committees, whereas the feedback that we have received is that these patients are considered as a vulnerable group, and, unless they do not have a document that is confirming them as a citizenship as a Turkish citizenship,

this patient cannot be included in the clinical trial, so we couldn't accept that in the way as it was. And we started making a, uh clarification request to the authorities, because the first feedback that we received was just simply, no, this is not possible. But when you are reading between the lines, actually there are some small hints, that make this process possible to enroll foreign nationals, but the whole process is extremely, extremely difficult. For some sponsors, this may not be valuable because it's a time-consuming and also the enrollment timelines are to be considered for every clinical trial. However, if you have a clinical trial, where you have difficulty to enroll patients, whether it is due to the study design or whether it is due to the inclusion exclusion criteria, or because of the rarity of the disease, then you should also consider every possible patient which is enrolled.

And, furthermore, if a patient who is, of a different origin lives in a certain country and cannot be allowed to participate in a clinical trial that he thinks he may depend on, the patient may benefit from it, in my opinion, it's not very ethical even though the patient may be considered as a vulnerable as the authorities referred to us in the response.

But it's just a simple example. I am living in Istanbul in Turkey, long term. If I'm going to have some disease and there is a treatment, that can help me in Turkey, I want to take a part in it. Or I remember, also other patients inquiring from Bulgaria to participate in clinical trials in Turkey many times.

This is quite a big interest and for this reason, you know, if there is this treatment available, I see a little bit illogic why to prevent those patients from benefiting from the treatment. So right now we are having this discussion with the authorities and they provided us with instructions, what additional documents

has to be provided in order to officially be able to enroll these patients into the study. So now we are in communication with the authorities.

Yeah. You're like, yeah, you're waiting. Help me understand. So they came back with some conclusion and basically they said this community, they're like vulnerable patients and therefore we think that they shouldn't be enrolled in the study. Or when we speak about vulnerability, do they provide any precise comments?

What makes them vulnerable? More vulnerable than other people to be enrolled in the study? Okay.

the reason number one was the language. So one of the main reason was that the patients who are of a foreign descent. They do not understand the local language. Therefore, they cannot complete the questionnaires in the local language and cannot communicate with the study team in the local language.

But, again, this is something that is quite different because what we are focusing on are the patients who are living and working in Turkey. So if you are living and working in Turkey, we also have a foreign patient who has a, Turkish, level of Turkish language, like language certificate you see.

And that's why we cannot simply accept this kind of claims. Of course, patients who do not speak Turkish, cannot be enrolled into the study, but those who fluently speak the language. Because of they have spent a certain time of years living in Turkey, those can be considered potential patients.

Besides the language, also the documentation. So like residency or work permit, because Turkey has a very, very strict requirements when it comes to a residency and work permit application and the document issue.

So, this is also one of the bottlenecks.

Yeah, and one of the requirements that was, given to us by the authorities is to have a certain specific approval from the directorate, who is managing the migrants. Yes. The directorate of migration. And after discussion with many colleagues from the Turkish industry, they have never had Such a request from the authorities.

So here you can already see that the information you are being given every time is completely different. And this is also the beauty and the main challenge in Turkey. The regulations, they are constantly changing and many times it is really different just follow the guidelines because it's constantly changing and the requirements are always updated.

And that's why it's so challenging to obtain this approval.

I am listening to you, and I have so many other questions, but the first one that comes, to my head is actually, okay, Turkey.

But do you know what's the situation in other countries? Is it the same? Let's start with the Balkans for example. Have you had any experiences in the Balkans, similar experience?

Mm-Hmm.

So in the Balkans, no. But, right now due to the conflict that has occurred in Eastern Europe, two neighboring nations, many of the patients migrated, for example, to the UK or to Germany or into the European Union. And the European Union was quite open to having these patients allocated to the sites across Europe.

Okay. So this is definitely an unexpected event. Yes. Like a major event that has changed the causes. Force majeure, force majeure events and the European Union were quite open to make these patients, eligible or to make these patients participate in clinical trials across Europe.

Even though the patients were not from the European Union itself. So I would expect the same approach in terms of Turkey being more open. As you said, this situation is occurring. And also what I have observed, there are studies that are enrolling foreign patients without any prior approval

of the authorities, which is not exactly kosher. However, in Rosenbaum Group, we are really trying to go along and play along with completing all the requirements of the bodies because, it can be an easy win. In the short term, but in the long term, if you have an audit or something, can not end up good for the study.

  I hope you're enjoying this episode. If you find this topic relevant, you'll find it helpful to book a demo with our team on trialhub. com. Since 2019, we've supported more than 3, 000 clinical trials with country, site, and patient feasibility. We'd love to show you how and help you get your trial right from the start.

And now, back to my guests.

 So from what I'm hearing, there is a miscommunication and misalignment between different regulatory bodies I'm speaking about and different institutions, like ethics committees, with the drug association, and the immigrants' agencies, and they actually have to work together so that they can make it possible for these people to be a part of these clinical trials.

And like you mentioned, I love that you provide a different perspective. Sponsors, they definitely are struggling because they have their sponsors in both like CROs like you. You're struggling because you have timelines, you have a budget, you hurry up to meet your enrollment target. But at the same time, if you don't go the extra mile for these patients like this old patient-centricity that we're speaking about goes, I don't know how, where, because these people at the end of the day, if they are eligible, if they can benefit from this clinical trial, or at least they want to try out, they should have the right.

So do you have any recommendations? How this communication can be improved? And third, can not only.

So, for Turkey, definitely the improvement that can be made is more communication with the CROs in person. Or at least via teleconferences because Turkey, one of the biggest benefits that I can say for Turkey is that they are using an electronic portal for study submissions. So everything is being done electronically.

That is very good. The problem is the communication with the authorities. It's either via email and if you send an inquiry via email. They send you usually to the portal to submit a request. So again, it's done electronically, whereas in cases like this ones, you really need to meet with somebody and to book an appointment.

Also in the TMMDA portal, we tried many times to book the appointment, but just the module is not working and you cannot book the appointment and officially they have appointment times only on Tuesdays between 10 to 12. I mean, it's almost impossible to book ad hoc meeting with authorities to discuss this.

And, this is making. Everything just more complicated.

Yeah. Complicated. Is it the same with the European portal? Because they released a new portal last year, so do you have the experience there, like a similar experience there as well?

So regarding the CTIS, since we are now focusing as a subcontractor, we don't have direct access to the CTIS. We don't use it as often many sponsors are doing the regulatory activities through the CTIS by themselves. So, usually this action is being taken either by the main CRO that we are working with, or the sponsor, but I can tell you from what I have seen and from the minimum activities we started, the whole implementation of CTIS is much more difficult.

Even German regulators, they pushed back and they said, we need to extend the time of submission in the old way. And frankly speaking, I do prefer the old way of submitting documents then through the CTIS platform because, how to say not to sound rude, the idea is good. But the execution is, it's still missing the fine tuning.

as expected.

Yes. And this is going to delay a lot.

It's very interesting because last year, maybe same time or a little bit like later in the year, maybe sometime in April, I think, I had another podcast episode with, Martin, the CEO of, LGK clinical. And he was actually one of the leaders.

He's also one of the leaders of the local CRO association, the German one. I think it's a German one. Yeah. And, we were having exactly a conversation around the CTS and the fact that it's a complicated platform, like a lot of. Different companies, different stakeholders have maybe pretty high expectations or maybe their expectations are like reasonable, but they don't definitely don't meet what's being delivered and that's causing a lot of difficulties in many cases.

Do you think that impacts like working through these portals, no matter whether we speak about the CTIS and the Turkish one, for example, does this. Make it a lot more complicated for, companies like you. Do you prefer the old fashioned way in like calls? Like you already mentioned that, but my questions around where's the balance between tech portals and direct communication with the regulatory bodies and ethics committties?

good and tough question. Certainly, if you can do things the old fashioned way. You will be in your comfort zone because you know the processes and, it is good for the speed of the processes, but also with the technology, I very much believe that if the CTIS is set up properly, then we can speed up the whole regulatory process per se.

In terms of the European Union, this will much help, for example, for the timelines in Romania, because I don't know if you are aware, but for Romanian approvals, it took quite some time. So, as a vision for the future, the implementation of new technologies is necessary, and it will be beneficial for everybody.

But in a short-term plan, it is just problematic and making things more difficult. And that's just because It is not properly set up. And I think that's all I can say to that.

can imagine. Yeah. I've been working on many projects, software development, governmental, and private ones as well, and I know that, it's very hard, especially when you work with multiple stakeholders, which brings me to my initial, our initial topic, the immigrants, and generally speaking patients, what should be their role in these technologies?

Should they also be connected somehow to these portals? Like in this case in Turkey that you mentioned, because the ethics committees provided the voice of these immigrants, but was the voice of the immigrants actually taken into consideration?

Interesting question. So in my opinion, for the moment, there is no need for the patients to be involved in these processes. However, the patients should definitely be involved in the patient groups. So groups, which are, large groups for patients with certain diseases and trying to find a way to communicate with the CROs with the clients in one unified voice. That's something the patients should do and be proactive for the treatment of their disease, whether it is an oncology disease, whether it is another autoimmune disease. This is what the patients should do because if you do not communicate with the clients, with the sponsors, with the CROs Then you cannot be heard. Some of the organizations in the industry, they are open to communication with patients.

However, they are still quite stigmatized not to talk with the patients. And I think that this is a very bad approach. How can you enroll? In your trial, if you do not speak with the patients, it is like, I'm going to make a carrot soup, but it's not going to be with the carrots. Right? So then what it will be just water.

Exactly. Yeah, that's a very interesting analogy. But then going back, so the ethics committee’s main role. It's to present the patient's voice and to make sure that, okay, not to present the patient's voice, but it's to make sure that they, that the clinical trials are ethical towards patients.

They represent the patients. That's their ultimate goal. That's why they exist in the first place. So if they are like if they're to have this main role. Then, wouldn't they be more connected to patients and wouldn't it be their job to actually be out there with immigrants? And actually, in your case, I just wonder I'm like thinking loud here Wouldn't be a good next step to actually connect these interested patients to this authority So they can actually speak even without you being the middleman so that at the end of the day the ethic committee can consider Okay.

Well, we still think this patient is vulnerable. They're not making the right decision right now because of circumstances, for example. And then you're like, okay, I understand. And I commit to what you decided. But maybe they can see that the patient's point of view is different. And that can impact their decision-making as well.

Hmm. Hmm.

That's a good approach. And I think if ethics committees could make meetings with the patients, this would be definitely more beneficial in taking their decision because the ethics committee, they are generally deciding on behalf of the patient, what is ethical and what is not ethical. If you look at the ethics committee list, for example, many times they are just a group of doctors or lawyers or Pope.

Yes, which is independent, a different pharmacist, the, , different, jobs and education levels, but definitely at least two times a year there, it would be a nice initiative for the authorities to organize a specific therapeutic area meetings with the patient to listen to the patients. And actually, this is what we are trying to do with the patients in Albania to help them be heard.

Yeah, that's very, very important. And I'm so happy to see that there are more and more initiatives to empower the patient's voice and I'm using these like buzzwords and even hating myself for that, but actually I can see that this is happening if more people like you, more companies are out there to support.

people with diseases to actually educate themselves how they can communicate properly what they're going through and their needs and their expectations. Then hopefully everyone that works in this industry can hear this, these insights in a meaningful for them way. And that can impact better, our projects and decision making and everything else.

David, I'm enjoying this conversation a lot, and there are so many gaps that I have. that I'd love to fill in after this episode, like, understanding better the ethnic committees and the immigrant situation. I definitely would like to dive deeper into the cross border initiative that the EU started.

So, I think it's not just for clinical trials, but it's throughout health care, basically. So that's a lot of things going on. But I know we're running out of time. So if there is one thing that you think will make patients, like clinical trials, I'm sorry. If there's one thing that will make clinical trials more patient friendly, what would that be from your perspective?

So Maya, you know my background, but maybe I forgot to mention that the beginning, and this is the key

for the future. I came to the clinical research industry by pure, pure luck because when I started, I was 20 years old and I had no university. I just, I was just speaking Slovak language and English and I decided to start working as a clinical trial help desk analyst, resetting passwords for metadata rave and other platforms. But throughout the time. I understood that clinical trials are my passion and I love to do it. And, this helped me develop a little bit out of the box thinking and a huge critical thinking when it comes to the problem solving. And currently the main main focus, what the whole industry should focus on is to focus less on the processes and more. on the human aspect of the study, because if you are focusing too much on the processes, you will turn into a bunch of robots and you will not be able to complete the enrollment because you will face the issues and you will not be able to solve them. If you think outside of the box, and if you are trying to put a little bit more human aspect into the study, then the things are happening. I think ...

That's powerful. More human focus. Yeah.

I mean, we are doing the clinical trials for the patients at the end.

True. Yeah, you're absolutely right for the patient for every one of us as well, because we're all patients one day, another day and so on and so forth. So, yeah, you're absolutely right. And for that, in the past, you told me something also quite insightful in order to be human centric. You also need to be flexible because people are flexible as well.

All right, David, thank you so much. I really enjoyed this conversation. I hope that your story will have a positive resolution anytime soon. I hope that conversation with David will raise some good questions, to many people out there and hopefully we'll work towards a more simplified processes, more structured, let's say platforms, but also better communication between all of us.

Thank you once again, David.

Thank you. Pleasure. All mine, Maya. And I'm looking forward to repeat this once we have some positive outcomes.

  Hope you enjoyed listening to Trials with Maya Z. If you're interested to hear more about how clinical trials can serve patients globally, subscribe to the podcast on Spotify, Apple Podcasts, and Google Podcasts. Have a great day.