 Hi everyone, so we're at time now, so I think we should start with the webinar. My name is Kate Morgan and I'm Head of Policy and Access here at Miloma Patients Europe. Before handing over to our moderator for the session, I just wanted to briefly welcome everyone to this MP webinar on access to clinical trials in Central and Eastern Europe. The webinar should last for around 90 minutes. Next slide please. During the event we'll hear from our colleague Ampere about the findings and recommendations from an MP report analysing access to clinical trials in the region and you can see from the agenda too that we have invited stakeholders to present their country specific perspectives on access to clinical trials. So we have Professor Roman Hayak from the Czech Republic, Professor Oliver Karanfilski from North Macedonia and Barbara Leonardi from Poland and we're really happy that we have such great speakers and a range of attendees to discuss this important topic today. Next slide please. So again I just wanted to go through some of the housekeeping for today's session. So you'll all have noticed but this session is being recorded so if you wish to stay anonymous please switch off your cameras and change your name on your screen. Throughout the event we kindly ask you to meet your microphones so we don't have any disturbances and we will have a Q&A session after all of the speakers have finished and as we're expecting quite a few people to join today please write your questions in the chat box which is at the bottom of the screen and we'll collate those and the moderator will ask them at the end of the session and during the panel and if you're facing any technical difficulties please use the raise hand function again which is at the bottom of the screen and one of my colleagues will come and help you. So today marks the culmination of a lot of work from MP, our partners and our members in Central and Eastern Europe and we'd like to say a big thank you to everyone who's been involved and who's helped us with this and particularly members of the Central and Eastern European workgroup on access and that's that's a part of MPE. So without further ado I'll hand over to our moderator for today Bebe Doddiver. Bebe is founder of the North Macedonian Cancer Patient Organisation Borka and she's also a board member for MPE and has been instrumental in leading the work that we do on access in Central and Eastern Europe and she's just generally a superstar so we'll hand over to her now. Thanks Bebe. Thank you Kate so hello everyone I'm Bebe and I'm so happy to welcome you today. This webinar is a result of a programme of work initiated and designed by MPE Central in Eastern European workgroup on access which I co-founded with my dear colleague Cristina Modic from Slovenia. The workgroup was initiated to promote collaboration between MP members in C countries as their access issues specific to the region we need to address as a community. So today we have members from nine C countries and the initial advocacy issue we identified as a group was variation in access to clinical trials. So as a result of this we commissioned a project designed to understand the barriers and opportunities for conducting and accessing clinical trials in CE. Today we see the launch of this work I'm very happy with this and alongside advocacy recommendation for discussion so we know this is a very complex topic so no one size fits all for quick solutions however through the report we want to start discussion and ideas for the future. To kick-start the discussion I'm very happy to introduce service first speaker MPE PICAT MPE works for MPE as access secretariat and she is an independent consultant she brings to the table over 20 years of experience working on access and advocacy issues and she has helped MP with coordination, analysis and write up of the clinical trials research so which she will present today. Quick reminder to mute your microphone and post your questions and comments in the chat. Over to you MPR. Well thank you Biba for the introduction that's great so I'll get started next slide please. Yes so and Biba already mentioned the objective of this research in that there was this knowledge of the lack of access to trials and equalities in access to ongoing trials so really MPE with its members wanted to look into it and decided to conduct this research so I'll just remind again the objective to inform the infrastructure needed to run clinical trials but also to identify the barriers to those clinical trials and based on the knowledge collected through these two objectives to develop recommendations for patient advocates to call for policy initiatives and action to address those gaps. So this piece of research is focused on the Mieleman and AL amylodosis community but certainly some of the recommendations also serve other patient advocacy communities. Next slide please. So this side is sort of a snapshot I don't want to dwell too much on my methodology but I still want you to show how we came up with the recommendations. So it was a three step approach which first run analytics of the Mieleman trial that were run between 2001 and 2020 WorldWild. Then we conducted a literature review on barriers and facilitators to clinical trials and with the data collected in those first two steps we did we interacted with stakeholders in three central and Europe countries to get their feedback on the information collected. Next slide please. So this is a fairly busy slide and I will not go into detail just to show you the process through which the Consilium Scientific company we worked with on this and supported us in that particular step. This is the process that they went through. So identifying 3,229 Mieleman trials which run between 2001 and 2020 and just going through the process of identifying them, cleaning the data, analyzing the data and reporting it. You will see there's one key takeaway I would say the report will provide more details but one key takeaway really for this particular slide is that of those 3,229 clinical trials only 201 trials recruited well sorry well yeah recruited patients from Central Eastern Europe so only 201 took place in Central Eastern Europe that's 6% of the totality of trials and for the purpose of this study we considered you know we adopted a wider definition of Central Eastern Europe than the one from the World Bank and the OECD so it covers actually 24 countries which you can see on this slide so this is a very large definition of the region. Next slide. So this table is really really interesting and this piece of the research that we got from the analytics you could see a chart with all those 24 countries listed and how they feature in terms of the number of trials run in terms of the number of identified Mieleman research centres and you can see that the top 3 countries in terms of the number which were included in Mieleman trials are Czech Republic, Poland and the Russian Federation so with 128, 95 and 79 trials. Next slide. So that's an absolute term because if you look in relative terms look at how Hungary is doing really well also 66 trials that's fewer trials than the Russian Federation but considering you know in relative terms to the population which is much smaller they're doing really well so this is really just telling us that some countries you know we should really look into best practices in countries that do really well in relative terms like Czech Republic is doing extremely well in relative terms as well. Next slide. Another interesting piece is just like who's running who are running trials and the picture is you know it's different to Western Europe in that the proportion of trials being also by industries larger. Next trial. Sorry, last slide not next trial. So now I'm going to touch briefly on the methodology for the literature review. This is quite detailed but I just wanted to sort of point of entry we're a bit naive initially we thought there was more in the literature review than actually there is on various the clinical trials in Europe and centrally in Europe so we focused on the disease Mieleman on the region centrally in Europe or Europe and then on clinical trials. We got zero papers in PubMed scopus or lens so it forces us to actually expand our research so we actually looked worldwide and when we look worldwide then we get a lot of papers from the US but this is what it is this is what the people what this is what the literature says so then we'll start to expand from Mieleman to oncology but also looking at immunoproliferative disorders hematological disease and rare disease to make sure we would get you know relevant papers to barriers and facilitators to clinical trials in disease areas that would be sort of have similar challenges than Mieleman and then we focused on on a five-year period. Next slide. So on the previous slide there was a table with search scripts so you know the the sequence of the keywords and the combination of which so with those three search scripts on those three databases we identified in the end 24 articles next and so the the data the information in those 25 articles which identified we actually wanted to structure it according to pre published literature to publish mythology excuse me and we chose that of Zimbida which you know published a narrative approach to barriers and facilitators to trial so there's different sort of questions to ask oneself so does the trial exist is accessible is the patient eligible is it presented to the patient and you know does the patient accept all these different steps aware things could just go wrong and you see on the right hand side and next to this chart and that for example five papers out of 24 you know you know touch on and touch on that particular topic of the patient eligibility so this you know these topics are being structured that way next and then just sort of really making sure that you know we have the right process the way we are presenting the data we also cross check against another narrative approach that of another researcher who identified four barrier domains so structural clinical physician and patient which actually correspond very much so to Zimbida narrative approach so with that sort of solid framework we use that to really present both the key takeaways but also the recommendations and I'll go into more details in further slides but I'll just talk in the next slide about how we conducted the the stakeholder interview next. So as mentioned after the analytics the literature review we wanted to talk to stakeholders in the region in an ideal world we would have like to talk to a large number but you know we we eventually spoke to 11 stakeholders from three different countries and just to make it really relevant we chose specifically stakeholders from a leading country so Poland so with a high clinical trial availability then we wanted to go for a country with a medium clinical trial availability so we we which was Croatia and then for a country with a low clinical trial availability in Macedonia and so we spoke to an initially country an dermatologist patient organization representative also a health authority representative and a clinical trial organization representative. Next so this slide is is a bit busy and but it shows the four barrier domains that I mentioned previously I'm not going to go into details in each of the sub bullet points because I'll just present the recommendations which are structured in the same way but I want you to focus on the bottom part of the slide where you say right below structural you see reasons for more than three out of four U.S. cancer patients because the publications are mostly about the U.S. but you know the reasons why more than three out of four cancer patients do not participate in trials are structural this is where the the biggest challenges the biggest barriers lie then at the other end on the patient on the patient end you know when eligible patients offer the trial they actually accept yes 50 percent of the of the time so you see in terms of how this sort of weighs in is reflected in the number of recommendations that we drafted so we drafted 27 recommendations in total 17 relate to the structural barriers which is where we found the problems the most problematic and to relate to patients and then for clinical barriers we've got five recommendations and for physicians we've got three next but before we present those recommendations to you we know and as Beba highlighted and also Kate we would like to have a word of caution because we completely understand that all recommendations may be applicable in all countries due to a varying level of resources which will make it very difficult to implement might not be applicable might not be relevant to all but really the purpose here is to get the conversation started lists issues that were relatively you know really pointed out in the literature review and by stakeholders and we look forward to your feedback and questions in the chat next so as I mentioned 27 recommendations 17 are about structural barriers they're very you'll see in the report you have when you have time to read and they're very well detailed but I'll focus on some keywords which are listed on the right hand side for time's sake so recommendation one and two are really about cross-border research networks so to establish some join or work with existing ones and the benefit of cross-border research networks is really to have a more sizeable Neelama patient population for trial responses so really to have different countries joining together to offer a sizeable and patient population also that would help facilitate trial preparation and implementation and that would also help raise the international profile of CE researches recommendation three is really I mean stating the obvious but you know there's a need for more investment in R&D but just for stakeholders to really encourage and so pressure upon policy makers and decision makers to invest more in R&D the fourth recommendation is really to go to learn from best practice best practices from from various European countries in where some national rare disease or cancer plans were in place which really helped create a momentum and promote clinical trials next please also in our recommendations we call for medical societies to play a role in defining minimum staffing and infrastructure requirements that's recommendation five but also in recommendation seven is to set up clinical trial training so really just to help define and train and define on the infrastructure and and train researchers and mythologists also we felt that participation or being an observer to the European clinical infrastructure network would be a benefit to CE countries also we we feel that there's a need and a really urgent need for policy makers in the region but also in outside of the region but within Europe to address the the brain drain and the healthcare professional brain drain because a lot of researchers move from Eastern and or Central Europe to Western Europe and this is really detrimental to to research in the region we also felt that the COVID-19 had impact on on the clinical clinical trial and it would be of interest to understand how that impact did it and but also how to further address similar situations in the future next so something of importance that was highlighted is the EU membership and and the regulation that come with it but there's a regulation that was in that it's being implemented its implementation started in 2022 and we'd like to encourage stakeholders to monitor its implementation but also encourage non-EU members to look into this to this in this regulation and try advocate for and encourage that their own processes align as much as possible with the regulation so that it would it would stream down the process for them and to be for those countries to be included in international trials we also recommend and encourage EU stakeholders to look at back best practices in those countries that do really well in relative term in regulatory processes but also in terms of their international and R&D reputation so the Czech Republic Bulgaria and Hungary especially also we'll recommend that stakeholders in the region promote the creation of contract templates to shorten the contract regulation negotiation time next and to conclude so on the structural barriers so we also feel that you know journals and medical societies also could support and promote the participation of CE researchers by giving them dedicated funding to attend conferences but also to be able to publish in the journals also we you know we recommend sponsors to to arrange as much as possible for routine tests to be conducted in local hospitals versus the the experimental center so that way patients don't drop out in the process of the trial that it makes there the burden the emergency birds and the travel burden less and so that patients would just stay on the trial the longest possible also you know we recommend industry to provide travel and accommodation allowances to patients and their carers and also we recommend that there be an agreement in the research community on a short list of data management programs because there's a multiplicity of those and smaller hospitals cannot afford to purchase them also that's one piece as well next also so this is clinical trial barriers so we'd like we really recommend sponsors and increased sponsors to use broader inclusion criteria more often than not the inclusion criteria are very stringent and it's very hard for patients to be included very hard to actually find those patients we also recommend industry sponsors to support access to clinical trial to see patients by accommodating for different local standards of care and you know it's just it so happens that if those standards of care in the trial are just not nowhere to be found in the region then patients cannot access it also I recommend policymakers to establish or join existing cross-border research networks as I've mentioned earlier next and so the the the last two recommendations on clinical barriers is for to call for more homogeneity in the treatment guidelines than the clinical practice because what the patient will get in prior lines will definitely impact you know how and if he can she of if they can actually enter a clinical trial so this is really key that patients have the same chance at entering a trial by having an homogeneous clinical practice we also encourage you know stakeholders to look into fair pricing models to access standard of cares in clinical trials which is a big challenge next one please so now we're touching on the physician barriers and we identified three of those you know it's it so happens and this is published in literature review but also being discussed by patients is that not all physicians will actually discuss clinical trials with their patients not all immunologists do and it requires knowledge so we really encourage all stakeholders and healthcare professionals included to actually use the EU clinical trial register and promote the use and share information with their patients we also recommend that national international medical society set of training on how to communicate clinical trial information to patients because it could be at that particular point the immunologists will actually talk about a trial but is not trained in communicating in a more user-friendly way and patient not understanding what it has taken how the trial protocol is and so forth may not feel in a position that they can accept the trial also we'd like sponsors to involve patient representatives to not only to review the informed consent form but also to inform the clinical trial design which is really important next slide please and I'll conclude on the two patient barriers that we identified is that and two recommendations sorry two recommendations that we've identified to to help address and pay that barrier is that for patient organizations to to dedicate some time and resources to providing user-friendly information on trials so as you know clinical trial.gov exists for physicians but just providing a more user-friendly type of information to relay that in there in then in their own country and also we as mentioned information we collected in the literature is very much US focused so really we know understand and acknowledge that further research in country specific barriers to trials in central Eastern Europe are really needed so this this piece of research is in principle what has been published but we really want to actually go beyond and look at specifics in the region next and with this I'd like to you know to thank to provide some sort of limitations to the work there's always you know as much as this been such a huge team effort and as mentioned by Bebe and Kate and thank you to everyone but you know we had a really solid trial analytics we can't either to review but as mentioned a lot of it in the literature is US scientific and we only interviewed 11 stakeholders so from three countries and we probably have certainly missed some specifics from other countries so this is a kickstarter for conversation and we want to go beyond and go further and we welcome your contribution and input and and also we'd like to mention the recommendations here do not represent the opinion of the people that were interviewed we give special sense thanks to considering some topic without which the analytics would have not been so so fabulous also pet buckets and the professor Dominic Ditfeld Dr. Kinder, Professor Karen Filski, Barbara Alonadi, Mira Armour, Miajana Babamova, Eva Ordak, Maria Traveski, Besnik Hamiti, Lukash Vish and Gjoko Tolorevski and thank you very much. Well thank you NBF for your helpful insight and recommendation on access to clinical trials so you can find the shared link in the chat with this recommendation and well for me it was a very interesting to see how each country compares in terms of clinical trial access so North Macedonia my home country has a small number of clinical trials in my myeloma so the situation across the Balkan is very similar particularly in non-EU countries with no synchronization with EU legislative so I'm interested to hear the perspective of the panel during the webinar on why this is and how it can be improved so well our next speaker is professor Roman Hayek, Roman is a professor of oncology and head of the department of hemat oncology in the university hospital Ostrava. Roman is extensively involved in clinical research and trials in the Czech Republic he is the head of the blood cancer research group in the University of Ostrava and it's a chairman and a founding member of the Czech's myeloma group so we are looking forward to hearing him speak about this research. The floor is yours professor. Okay thank you Biba for a nice introduction. Hello to everybody good afternoon. Actually you know congratulations for such excellent analysis focusing on this clinical trials issue and challenges in our region it's really really important so it's actually one of my favorite topic in fact because I actually established first the clinical trial units exactly 20 years ago at that time I was in Brno and after moving to Ostrava 12 years ago there was nothing no clinical trials in Ostrava so we establish general clinical trial units and after 10 years now we are where we are so that would be just brief summary and some comments because yeah it's really important topic so next slide please so that's an example about our department of hematococcal gene Ostrava focused on active trials and you can see that we are currently running more than 80 trials in this year this year and one quarter of them has active enrollment. Of course I'm myeloma guy it's my favorite topic so more than one third of trials are focused on some monoclonal gamma party smoldering myeloma newly relapsed myeloma or even plasma cellular chemia or amyloidosis. So I just add information about new type of trials focusing on new immunotherapy tools like RT or by or three specific antibodies in fact we just opened another one so we have now active six trials and on the bottom you can see the distribution between the type of trials phase one two and three and we're trying to now already third year to change our strategy be more focused on more difficult but very interesting phase one trial and especially even phase one first of human use trial which requires even some special certificate from regulator authorities and then you can see the proportion about academic and sponsor trial actually this is not correct because it's proportional about patients in academic and sponsor trial and there are probably nine percent of academic trial currently in our department so that's how it's organized and what we achieved and what is available for our patients which is of course important for them next and this is example again focusing on what what we need really from infrastructure to run the clinical trials so we have a study team total of nine data manager researchers sitting in three rooms we have one another extra room for CRO staff monitoring the clinical trials and okay what you need is educational room as a part of outpatient clinic but the same is for large store not as a only part of outpatient clinic but you need more large stores definitely it's really nice for data managers and researchers if the centrifuge refrigerator refrigerator and freezer are specifically reserved only for clinical trials and exactly placed in outpatient clinic it's very convenient for them and then we have biobank and flow cytometry facility and both of them serve now as like central lab for check clinical trials IIT trials or trials under Umbrella of Europe myeloma network and of course if you're running the clinical trial space one you need special room special equipment and especially the place is important close to intensive unit care so that's the conditions what you need from infrastructures and team next please and you know it was nicely reviewed executive summary and 27 recommendation with previous speakers so I have just few comments from you know my perspective and based on my experience definitely establish or join cross board research networks that definitely could help and I definitely encourage anyone who want to visit our center to learn how we organize the clinical trials certainly will come then it was mentioned the European clinical research infrastructure network and you know to me it's from our countries it's only in Czech Republic Czech Republic is member they are this green is in Bruno but they have no impact actually to our activity the reason is because it's not only for cancer trials but it's for all type of trials of all type of diagnosis first and they have of course limited capacity and then they are focused on IIT trials academic trials and if you have some then they can they can probably help significantly and of course critical for good start it was several time repeated is really minimum staffing requirement job description hospital infrastructure as I try shown before next slide please and from other comment definitely important is training and peer-to-peer support programs on clinical trials to me COVID era actually now have no impact probably at the beginning had some limited impact but I think it's not needed to explore it even definitely to review best practice good positive example from countries like Czech Republic that could help identify some issue and challenges and to me it's usually not needed even to be focused on local hospitals to me the most important is to be focused on large main usually university hospitals in region region should be size as starting with half million of habitants one million plus is definitely better and local hospital and university or this main hospital that should be very flexible network that's that's that's then working and it's exactly what we are actually doing with regional hospitals and regional hematologist inside the Czech Republic it's nicely working next and then of course the you know clinical trials are important for university hospitals and management of hospital usually don't care significantly but they should recognize how important this for for hospital and I just briefly summarize it's important from patients perspective and benefit because there are so many animate neat clinical situation and of course if you have some option in clinical trials that really can significantly help to our patients then there are some academic benefits you know we are you know exciting if you can use new drug novel immunotherapy by specific three specific antibodies then we have to be seen you know so so be part of the publications that's that's important and usually typically in academic clinical trials but also in some pharma trials there are some type of collaborative research so again we can be involved in research from this is important from academic point of view and of course for the management of hospital is important money usually so the first I've always emphasize that the drug is for free at least the experimental drug is for free and usually replacing quite expensive drug which which cannot be used if the patients is enrolled the clinical trials and this really is significant and then of course running the clinical trials inside the hospital especially pharma trials it's you know it's a significant income for hospital I just use this model for illustration from all money coming from from clinical trials we first fix expense for data management team then we have something for physicians and bonuses then we have some operating expensive for all related things to clinical trials running in a hospital and then still significant profit for hospital just in Hauhen for example it's close to 3 million euros per year so it's significant and next finally I just try to emphasize minimum starting set for clinical trials we definitely need at least two data manager one is not enough because you always need some backup one room for data manager extra fridge or freezer and freezer education room one store room and definitely three four dedicated doctor who are willing to run clinical trials and participate and of course the most important starting point is to sit with management directors deputy directors and make some agreement that these conditions are mandatory and otherwise you can run the clinic returns so I think it's my final slide next slide please yeah yeah and next please and that's it thank you for attention happy to answer any question thank you professor roman for your presentation so you work in chairs republic is very impressive comparatively high number of trials in the country highlights the ability to attract research in myeloma and the important role that doctors and researchers have in collaboration in promoting a good research environment and actually there is a lot we can learn from the success of the Czech Republic and we look forward to discussing this further during the panel so our next yes and well our next speaker is professor Oliver Karanfilski from university clinic for hematology from scopio north masonia he is a professor of international medicine and head of the induction chemotherapy and the intensive care unit at the university clinic as a living expert from the Balkans on hematology he is a past president of the board of the national Macedonian hematology association and a founding member of the Balkans myeloma group so given his experience we will provide an overview of his research experience in north Macedonia and what currently is happening in our country so well professor Karanfilski the floor is yours thank you be well good afternoon to everyone and i'm very glad to be among the speakers here especially because i have the least good things to say about clinical research i was very pleased that professor Hague just touched the issues that we are still facing and probably that what they have overcome is a good result from joining the EU these differences between EU countries can be seen i mean founding members of the EU and the new members do have differences and they were well well visible in the table as well that Anne Pirret showed at the beginning but this is an idea a vision to unify our practices and possibilities to in get involved in clinical research i'm speaking from a country that has some geographical attributes that are not very easily understandable i mean we are belonging to a southeast european region members of the western Balkans and have north as an attribute for the country so this is all over the world the country as as i see it we can go to the one of the two slides that i have prepared their text slides so what are my opinions my views on why we don't have clinical trials at all or enough to play any kind of a role in managing to to establish a common common surrounding common environment and common conclusions about this and other diseases as well the first obstacle as i see it is the low recognition of the people working in hematology and myeloma in the region because we are mainly doing clinical research which is not the kind of research that the good papers would publish very large studies yes they would publish but in a country that you had a data that we are over two million one hundred thousand and the census of 2022 revealed results that we have decreased in size by about 10 so 1.8 million is the current status of population of north macedonia so there is only one hematology adult center and one pediatric hematology center so this is not a problem this is centralized by force of nature but doing clinical research meaning seeing outcomes and risk factors and treatment options and the results is the only thing we can do since financing in laboratory research is very scarce if you don't have clinical trials or results that would be worthy of a good medical journal then you you have slim publishing publishing options as well as it is also limited by the amount of money that would be needed to publish in a in a in a good journal this is something that equals about six monthly salaries of a starting physician in in our country so with all of this said it is not really possible to establish this expert status that will be visible to other colleagues around outside the country and this is a vicious cycle if somebody doesn't see you then you don't become a member of a clinical trial if you're not a member of a clinical trial you become less visible and so on it is very difficult in my country to try to treat patients by expert guidelines there are two guidelines that we mostly respect us and european so we need to adapt this is in a word that i chose to adapt to local circumstances which means adapt to what medication we have and what procedure and what procedures we can we can impose for the patients patients if we don't have some medication it would be okay but not to have maybe a second or a third line of treatment in several diseases would certainly limit the possibilities as professor hayek said the regular stuff you need to have the experimental drug will be given on account of the on the clinical trial yes that also includes some sophisticated diagnostic options we do have let's say flow cytometry we do have pet scans but when it comes to some sophisticated diagnostic options we i'm sorry to say but we don't really have them this also applies to investigational procedures we have gone in the world of my loma to diagnosing and monitoring patients with next generation flow cytometry next generation genetics and some of this we have but are not available to us and what professor hayek accented is that we don't have an existing statistics department which would be specializing biomedical statistics we do have a department of statistics but this is general and people over there do know the basis of statistics and details of statistics but it is not too much defined towards biomedical statistics survival bfs and stuff like that data management is performed mostly by medical doctors who would become a part of the of the clinical trial so this is not a specialized profile among this there might be problematic selection of patients where we would probably include our possible bias and this is what resulted in in patients failing to to survive the the clinical trials that we were included as little as they were in in the in the report of unpure not having the monitoring from the inside and certainly not having a centralized monitoring would problematize our data reporting because some people would feel that they're not as accurate as they should be that we include bias in reporting the outcomes or the level of success we have had with the treatment and when we define endpoints and outcomes we might be slightly adapting to our terminology this is why monitoring needs to be centralized and it needs to be from outside because in a small country where everybody knows everyone it's it might have some flaws selection of trial participants is a big question because if you don't have the so-called expert as a recognizable person then somebody that is running the trial should know should have a criteria how to choose the people that the trial is going to function with in our micro environment so this is a problematic thing having in mind that you cannot actually seek for the portfolio for the portfolio of the expert you are you're looking for to include in the clinical trial politics does have an influence in the profession and in the clinical trials because managers of the institutions and medical institutions are appointed by the political establishment and this is often not a person who has the expert status not only in one disease but in the in the field as it is now so this is what we have to deal with and obviously with trying to enter the union we are probably going to have some solutions that are going to overcome these issues we can go to the next slide Biba and over there I state what I think could be maybe improvements in this sense we do have quite a lot of discontent by knowing that we know the ways how to treat the patients but not having either the medication or the procedures to affect this and if we're not following guidelines we cannot use all of the guidelines available which means at least one of them is assigning to a clinical trial participating in clinical trials could enhance local visibility and expertise and also our patients could could benefit from this possibilities for including patients in clinical trials could provide them the innovative medication which we now lack they do standardize the treatment and diagnostic options for most of the patients or all of the patients so there are not going to be variations by individuals entered in the trial which is what also Professor Hayek just mentioned data analysis would be improved because if we managed to have a separate database or data management segment then comparisons and scientifically supported conclusions would be unified and centralized diagnostic possibilities could be upgraded enhance improved and international interventional procedures as well and we would have closer more dedicated care for the patients and the improvement of our performance status would be implemented on the whole department the whole profession what we need to provide as a starting point is enlarging of the territory and the patient number and this is what we're doing in trying to open ties between all the former us of countries and especially in the profession which we have done even before politically connecting with the other countries is we're trying to establish a community a network of regional centers hematology centers is what we have already done in the myeloma bulkhead group which is led by Professor Yelena Villa from Belgrade and who has also acknowledged the needs to have a really recognized expert in in this group which is why she succeeded in managing and to include Professor Meletio Dimopoulos in this group which is a very valuable acquisition and we hope then in the future we could present a wider array of patients entering and having the possibility to enter clinical trials thank you very much well professor Karam Fjulski thank you so much as a patient advocate for North Macedonia the key messages of your presentation really resonate so you as an expert in North Macedonia and it has a very important role and not only as a medical expert that recognized and support the patients in their needs and work together for overcoming the challenges that are not only in Macedonia but also visible in all other countries so synchronizing the legislation of EU implementation of that daytime biomedical statistic of course and the Balkan myeloma group I believe that will help to overcome the barriers and opportunities for conducting and accessing clinical trials and CE but as you said in your presentation we need to constant political establishment so I hope that this idea and work on Balkan myeloma group will be result to have progress in order not only to access the clinical trials but as well as the new therapies that could prolong patient lives and will be recognized by the policymakers in our countries well I will move forward so our fourth and final speaker is Barbara Leonardo Barbara is a patient advocate and she is a member of Carita the Polish multiple myeloma patient organization she also recently joined the board of NPE so Barbara who was diagnosed with myeloma 2019 is extensively involved in activities as national at national but also European level promoting access to treatment and clinical trials she will present her perspective as a patient advocate and experience of the situation in Poland and the central and eastern European countries so Barbara the floor is yours thank you very much Biba and a big thank you to NPE for facilitating and publishing this research I really think it's extremely important and I will say a few words about a patient's experience and of course it will be focused on Poland and based on my personal experience and conversations with other patients however I think a lot of these points are quite universal and can also apply to other countries so let me start with a simple question why do we need access to clinical trials I think we can see three main reasons one very basic very obvious that was already discussed are therapeutic reasons so clinical trials provide access to modern treatment and the address unmet needs and as you all know and this both professors said there are still gaps between the western Europe and the central and eastern Europe and there is still a lot to be done in our countries to close these gaps and clinical trials part a big role here another big group of reasons is education and awareness about the disease and I mean it in a very broad sense because one aspect is the clinical trials provide education for medical staff for clinicians and for nurses and also can provide some professional opportunities and make the hematology profession more attractive but I think it also can raise awareness about the disease about the diagnostic process about the symptoms because the more we speak about it the more information will go to the media and will reach the public and this is what we need because myeloma is still it's a rare condition and still is not not many people are familiar with it not many people are able to notice the symptoms especially that as we know they are not very specific and what is very important for patients is the psychological impact and for patients this is something extremely extremely important and makes a big difference during their therapy one aspect is to give hope because as we know myeloma path hopefully can be very long and will mean which means also you know many treatments on the way so when we know that there is something there along the line it gives hope everyone and can can help during their during their myeloma path and also when we know that there is some clinical trial we know that we don't need to accept whatever is offered in our country we can always try and get maybe something better maybe something more suitable for a patient because every patient is different every patient needs maybe a slightly different approach and let me conclude this slide with a case study so a female patient over 40 overall in good health started her treatment in 2020 with there were two options the standard polish treatment which is VTD plus the transplant and no maintenance versus KRD so treatment with carfilzomib that lasts 24 months only chemo and no transplant after the first part maintenance so two questions which treatment is better from the medical point of view I dare to say no one knows the answer and the second question which one can suit the patient better and this is the question that only a patient can answer but what we know for sure is that the standard treatment is heavy and creates a big burden on the life of the patient because the transplant procedure although you know it's well studied and it's it has been done for many years it's still very difficult for a patient and requires a long recovery period while 24 months of carfilzomib may sound like a very long treatment but is well tolerated and doesn't affect a patient's life very much okay we can go to the next slide please so yes what are the barriers from the patient perspective again I see three groups and I think also they were they were all laid out and included in the report one is access to information or lack of information first of all as I know from these discussions with patients the internet remains the main source of information it should be doctors it should be our clinicians unfortunately it's still not the case and as we know myeloma is a disease of elderly people so by default they are excluded because not all of them use the internet they are not so familiar with the digital world and how to find information another point is the quality of trial materials one case is how they are prepared so they don't necessarily take patient into account the materials are prepared in such a way that they require certain medical knowledge or knowledge of the medical language they are long they they are difficult to digest and to understand and on top of this so basically they are written with a different goal in mind they are for clinicians and on top of that we also have the problem with translation because it doesn't help if a difficult document reads as if it was translated by google so certainly there is something to be improved here organizational issues or structural issues this is something we already discussed one is where the clinical centers are located and they are in big cities because usually the trials are run by university hospitals so it creates a problem for patients to access them because a we have a cost problem a cost of travel a cost of accommodation because if a patient has to be in the hospital at seven o'clock in the morning very often they cannot travel on the same day they need to travel a day before and oftentimes these patients have to come with someone else because they are unable to drive or maybe they are not in a shape to travel on their own so we have additional burden on on the carers and the final the final group of barriers or problems is the perception of clinical trials we still it's still quite common that clinical trials are seen as medical experiments and that patients are guinea pigs and this is something that can be changed and probably you know can be addressed by some campaigns also patients are afraid to commit to something that they are not familiar with so if they don't understand the materials the documentation oftentimes they don't understand they can withdraw at any time if they don't feel comfortable or if they don't feel well with the medication another point is that the process seems difficult and complicated so again perception next slide please what can we do to overcome access barriers i think definitely this is something that has to be done has to be tackled by all stakeholders together because patient advocates alone cannot change that we can support pharma we can support clinicians we can provide data to policymakers but we cannot do it on our own so what can be done is definitely to address the information gap and change the image of clinical trials we should distribute the information more widely we should think of some campaigns that can explain to people what clinical trials are in general plus what they do in myeloma because many patients are also afraid that they will just receive a placebo so we there are points we could we could ask patients about their fears and then tackle them one by one so it's really good to see that there are such initiatives like the mpe's white paper because this can really change change something so we really hope that it will be translated into polish and because this is the chance to you know make it widely available and start a discussion start a discussion on the on the wider wider level and what is also great is to see that you know in poland we have a polish network for clinical trials this is a unit that was established within our medical research agency and there is also a unit dedicated to patients where patients can go and ask questions get information etc of course we are at the beginning of their road but it's great to see there are initiatives what also has to be done is taking into account patients perspective and this is something that both pharma stakeholders and clinicians should keep in mind and we this is an open question we can think about how to address patients issues if they can get some support with their problems of reaching the these big hospitals and maybe there is an option to review the clinical trial protocols to find ways how to make them easier for patients so first we need to really understand our target audience and understand what people are afraid about what their challenges are and then we can we can tackle that thank you very much well thank you Barbara for your presentation and giving the important patient advocate perspective so it is very important to hear the patient perspective from this topic such a access of clinical trials and it shows why clinical trials are so important how access issues impact on patients and why effective communication on clinical trials is of ultimate importance and of course the role of the patient advocates are to inform and inform and to empower the patients to be to take a proactive role in the decision making for clinical access but first they need to be familiar with the clinical access so well this concludes the presentation for today and now we are move into QA panel session we have been monitoring the questions as we go along so thank you all for all your questions you can still send it in your chat and we'll take them in order and our first question from the audience yes I think from Ananda plate was what is the panel's option on whether challenges in running trial clinical trials are country specific or myeloma specific do you think the challenges you found in some of these countries also exist in other cancers or disease areas or they're specific to myeloma uh some of the presenters could answer Yoica would I try yes yes professor please and in my view the main difference exists between countries that are members of the EU and countries that are still not members of the EU I would rather hear professor Hayak's opinion on this because entering or accessing to the European Union also requires that you unify the legislature this also means help legislature and I think that once you have a standard option for working in this field you are also enabled to be included in clinical trials so I believe that professor Hayak does have different views about the situation before and after entering the European Union as far as the disease I don't think there are any essential differences in trials regarding myeloma or other diseases it's a design of the trial that is usually different but the aims are also always the same thank you yes yes to the point professor Karam Filoski so our next question is regarding looking at the success of the of the Czech Republic when it comes to availability of trials in myeloma and how they're and I wonder how much of a driving factor is it is to have an influential clinical clinician like Roman Hayak who is internationally recognized and who is invest time and efforts in attracting trials to his home country and how much this really depends on the other factors such as infrastructures, commercial interests, etc. I think that we already mentioned that in your presentation professor Karam Filoski or professor Roman you can also explain the differences in the importance of these factors yeah okay so I can agree it's always advantage if somebody from the country is internationally recognized that's definitely benefit but not it's not just about that you know it's really important for especially pharma companies have three four key centers with very good quality and ability to run the clinical trials so they really can realize that it's a pay in the end and they they want to open the country so the the first step is to decision to open the country and this is usually based on history experience and cooperation with the four or five centers from the countries it's make some you know like some some critical critical number of potential of the country and it's really really very important so so so that's for me starting point to have agreement inside the country two three key hospital you know make some announcement they are ready to they establish some basic facility for clinical trials and conditions make announcement and probably at that point we can we can we can help because the pharma companies very frequently ask who won't be another partner in these clinical trials and even for some specific clinical trials they probably require now to be anti-CD38 Navy which probably is mission possible to have patients anti-CD38 naive so so in Czech Republic and western part of Europe but it's possible in in in in country which usually these drugs are not yet rainbowed so so we can even help with some recommendation and redirection but that first we need to see that this is some critical two three key hospitals guarantee quality of the trials in country yes well thank you thank you professor roman the next question from our audience is diagnostic and their importance in trial we were discussed a lot today in the presentation of the doctors but what ideas do you have on improving access to diagnostic you know it's always important topic but i think it's not related too much to clinical trials yeah okay well it's a very important to have access yes we cannot put aside this this topic because we were we were witnessing the the the time frame between countries and the importance of diagnostic prior at the beginning of the of the disease set after it's in the latest stadium so well the next question maybe yeah i would i would like to add to this sometimes uh in the in the layout in the design of the study you need to have some kind of a facility or some kind of method for diagnosis if you don't have it you cannot become a member of the trial so this is also yes professor that's why i thought it is very important but maybe maybe you you could ask what do you have what do you think there's the best ideas do my loma vulcan group has some ideas how to improve this access because it's related to the clinical trials some investigations are possible to do across the border but this is not what we are striving to do i mean knowing that there are methods with which you could improve the diagnosis and with that the prognosis of your patients are something that a country and institutions should strive to have for their own patients so this is something that is a normal evolution of the health system so i think improving and enhancing the diagnostic possibilities do bring you closer to a clinical trial this is why it is important to to have the improvement of diagnostic and therapeutic options as a precondition for being included in clinical trials yes yes so the next question is regarding what you are seeing about the legislative as a bureaucracy issues but we would like to hear for example professor Hayek what is your experience with the bureaucrative issues so ethical approvals in setting clinical trials up because you show very good results in the Czech Republic so how do you think we that we how do you think that this should be evolve in in the future or overcome how to overcome these barriers i think the bureaucracy can be overcome because it's elsewhere you know and even you know i know very well do you know the administration procedures in key university hospitals so sometimes in some period of time in one hospital it's it's takes like four months it's okay in another hospital it's eight months and in another hospital it's mission impossible go through but after five years the management of hospital change and situation is opposite in hospitals so it's really fluid field and bureaucracy is elsewhere and only what i always doing you know as because clinical trials are for me important i always keep pressure on the management of hospital you know asking the lawyers if it's everything is clear blah blah blah so it's it's need be proactive that that's my recommendation otherwise bureaucracy is elsewhere well well yes so professor karantulski mentioned vicious circle in which the gap between the countries where trials are running and those where they're not running becomes bigger and bigger and well and pier do you have any thoughts around what will be the first step of how to overcome the vicious circle and is there any way patient organizations and patient advocates could be supporting researchers in this country to improve the situation i mean this documentation and this work of c countries within the mp program result to this all recommendation but have you any thoughts about this well i wish i had the solution you know just to say hey you know let's stop this and that because it definitely varies you know from a country to another but the you know the list of recommendations is the reason why we have you know we were trying to be thorough is to provide a list of options to sort of choose from down that would some would be more easily manageable than others so it's hard to say but as pointed out by professor Hayek certainly the patient organization could advocate to european and global medical societies to provide support in terms of training you know for for researchers certainly also provide support in the sense of you know help see researchers attend conferences have you know allow give more grants also medical journals support see researchers so that it's you know it's not the it's very expensive to publish you know regardless of where you allocate i mean in a lot of us and you know western european researchers say it's very expensive but relative to you know ggp in central eastern europe it's even more expensive so i think as patient organizations just advocating to it's a start it's not the key but really empowering researchers to access that knowledge to access that training being more visible that would be already a tremendous start then obviously the funding you know it's a problem if the government of a particular country does not want to invest in r&d is challenging but if european medical societies would help them just to you know to benefit from expertise from other countries like check republic for example and that would just give that would incentivize policymakers and decision makers to invest more because they say you know what we have researchers that are published they're trained let's invest so it could be an entry point yes well thank you thank you npr we have one question from the pharma so one of the issue that sponsors may have is the questions of whether it is ethical to run a clinical trial in a country where after the trial there is a very low chance that the medicine will be available for routine use so is there is no realistic chance of getting the local reimbursement so it is ethical to do the trial so what is the panel's view on this dilemma how do you how do these results compare to the results of the mp atlas i do believe that is still very ethical because never is a clinical trial unicenter think it's a multi-center thing and then you actually use the results if of course they're positive and you use them to do the pressure that professor hayek and everybody's talking about on the government on the authorities and say we have conducted this clinical trial we have proven that we have a better option of treating and saving patient lives with this new regimen and therefore we press you to approve these drugs or this regiment or this combination for further treatment of our patients so without that you don't have any means i agree if i may yeah i agree and it's a chicken egg thing because if we say we anticipate it's not going to happen it will never happen i mean then because in any country we'll say i want data about i want patients my patients to be in that data set if those patients are never included it will never happen so i think this is this is ethical because it's just we need to get we need to break that vicious circle that that professor carversky mentioned and if we don't include patients from from central more patients from those countries then that's just means that we're giving up on them and that's just from patient advocacy perspective that's unacceptable that's my patient advocate hat but i absolutely agree yeah uh yorika could you please send your questions in the chat we have uh well i i would i would i have i don't have a question i have a comment and i would rather talk instead of sending my my uh question first of all i would first of all i would like to thank all the speakers for their extremely illuminating presentations i'm quite content with everything in me in the sense that it responded all my queries i would like however to refer to something which and uh on the pickers uh stated uh when talking about barriers in my opinion one of uh the very important barriers which has not been covered unfortunately relates to the pharma lack of interest uh i'm saying that particularly after seeing the the chart where pharma according to the chart presented by an pharma covers 90 percent uh or organized 90 percent of the clinical trials however i can't rate how much 80 or 79 percent that was from the quite a lot it's still quite a lot however having in mind the very low number of clinical trials organized in rumenia and i will speak to rumenia only it seems that out of this 85 90 percent you know pharma has not been too much interested in organizing clinical trials in certain part of eastern europe and this is the fact and unless we confront this openly we will never be able to we will never be able to address the issue because we are living in a in a time where policy and finance controls our life and because we are speaking of finance when we talk about clinical trials it is very important for pharma to take some interest in organizing this kind of clinical trials in our part of europe particularly that mpe wishes to launch a white paper uh for addressing the barriers unless you stipulate this barrier i'm afraid that you will end to almost anything but to present to preserve the present status book so uh in my opinion you know to conclude uh it should be mentioned in this white paper the very low interest of pharma in organizing clinical trials in countries such as rumenia and i'm quite sure that the reason is not necessarily related to the fact that a lot of a lot of doctors migrating migrated to other parts of europe yes i do not know thank you yeah well thank you uh yorika for your for your comment is it true so we are we are having a time only for one final question so so as you said as you mentioned so the last question will be from recommendation and solution discussed today which ones do you think would make the biggest difference to clinical trials in cea countries if implemented well from my point of view you know always choose one two three key centers in the country uh working together establish conditions for clinical trials and then the second we can you know educate anybody from any country's high living will come and your part is probably to advocacy to talk with pharma business pharma companies saying okay here are the centers in this distinct country and probably you should consider these centers to be active in clinical in your clinical trials something like this you know yes well thank you uh unfortunately we have reached the end of the session we are so pleased with the uh rich discussion at today on access and trials clinical trials in cea and we're really hopeful uh this will facilitate meaningful work and discussions on improving access for patients and uh reduction inequalities so as a next step i would strongly encourage you to download the report and recommendations uh kate already sent you but and let us know any additional thoughts and perspective on the topic by emailing access at amp europe.org or address the topic for further we are planning a multi-stakeholder discussion event next year on the topic of access to clinical trials and medicine access to medicine in cea country so please register your interest in amp work in this area and the mail is also the same access at amp europe.org so well thank you very much all for all the uh for all the speakers for your insightful presentation and recommendation and have a wonderful afternoon everyone okay thanks everybody thank you thank you everyone as well thanks bye bye