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Anders Bjartell: Really would like to underline a lot of what has been said already, that collaboration is the key. There are difficulties, we need to be humbled and there are different ways to go. And we need to look at more international perspective, and also, to really collaborate.

So these are my disclosures.

This is what I would like to present to you today, a little bit about what is the EAU Research Foundation, previous and ongoing studies and registries, and future strategies, and what we believe would be good to work on in the future.

The EAU Foundation for Urological Research has been around for quite a number of years now, and the aim is to promote, and facilitate, and stimulate, clinical research, but only basic research also, and set up a number of registries. So we really would like to bring together to create European network within urological research, and to connect centers, and not only urologists, but also, a multidisciplinary collaboration.

So if you go to the EAU website, you can find this picture, the composition of the board. Where you have a number of extremely talented, good and experienced researchers, focusing on clinical studies, registries, basic research. And especially, I would like to highlight the importance of engaging the young, extremely active. And one example is from Milan, [inaudible 00:01:50], and many others. And you can also follow us on Twitter.

So, just a few examples of what we have performed within the EAU, and what we have supported from the EAU Research Foundation. One of the studies, probably the most successful study, was the study on the MRI by the group in London, many, many collaborators. The PRECISION study was published a few years ago, presented by Veeru Kasivisvanathan. And that showed us, and really changed our guidelines, how to perform MRI before prostate biopsies. So this was a big success.

Another study, that we believe could be a big success, and this has been discussed earlier today, the shortage of BCG. So one way to go would be to reduce the number of BCG installations. So this was a noninferior study, but it was actually stopped half ways after an interim analysis, which showed that it was not good to reduce the frequency and number of BCG installations. It was the opposite. So we had to stop the study, but it gave us a clear answer, that we should not reduce the number of installations, and that was published in European Urology. And now, we are offering young urologists and others to make sub-studies on the database that we have created.

Another example, and this is to be humble, that we're not always successful. And this was an excellent idea from Andrea Necchi, to treat patients after cystectomy with adjuvant and FGFR3 inhibitor, after a molecular screening with a foundation one test. Unfortunately, less patients than expected, only about 10%, showed positive screening for the receptor mutations. So unfortunately, we have to stop the study and that will be published in a report soon.

This is overview with somebody, ongoing recruiting, registries, and studies we have now. We have great variation here within urology, we have not only oncology studies, we all also have other kind of studies. One example is preemptive study. This is the registry, because we have identified a gap of knowledge in the guidelines how to, in the best way to treat priapism. So that was also an initiative from an Italian young urologist. And then, we have the ROGUE-1 registry, setting up with T1 bladder cancer registry. So you can find more information about this on the website.

And then, I would like to highlight again, the group from London, Caroline Moore and Veeru Kasivisvanathan. And after the PRECISION study, now they have started a PRIME study, also supported by EAU Research Foundation, but also from other sources, funding bodies.
So the PRIME study would probably recruit quickly. So within two years, 500 patients will have been recruited. And this is to answer the question, can we go for biparametric MRI in the future? Or which patient doesn't, will it not work for? So it's a noninferior study, and within the first 200 days, many patients and nine, almost 10 centers now actually, have been opened, and the recruitment goes much faster than expected.

So another few upcoming studies. We have the BRAVERY registry together with Andrea Necchi, in the group in Milan, to collect rare variants of bladder cancers. And then more recently, we have now, together with a group, together with Eric Barrett in Paris, and Juan Martinez-Salamana in Madrid, designed a prospective multicenter study, to collect a lot of information about focal therapy in prostate cancer, which will be more and more in focus in the future, we believe. But there is, it's been discussed for many years to set up a registry from it, to really understand, what is the best way to go with focal therapy? So I hope we can get some answer. But that will, of course, also take a number of years. There will be about 27 centers engaged.

And this is another recently redesigned study, an initiative from Vienna, and from San Raffaele, where we would like to look at patient treated for oligometastatic prostate cancer, diagnosed using PSMA-PET/CT, and then to analyze the time until they are castration resistant. So this is also under planning, hopefully, it'll start before next summer. And there will be at least 12 centers, different centers from Europe involved in this.

So now, to also something that we believe will be important in the future, and that is to... We understand we cannot do prospective randomized trial for every gap, to fill every gap of knowledge in our guidelines. So we need to look at something different. So in the future we believe, and it's already been mentioned in the discussion today, that big data is important, and to collect and combine data from different sources.

So the first initiative was taken by James, professor James N'Dow, urologist in Aberdeen, I'm sure you everyone know James by this time. He took the initiative about five years ago, and EU, the European Commission, they funded this IMI initiatives, big data, for better outcome in cancer. And it started, so it's been ongoing for almost five years now. I've been the deputy academic coordinator on the study, and we have learned a lot.

This is an overview of the group here. It's a big group working together, also with excellent input from the Milan group. And there are about 35 public and private stakeholders. And we have really had a possibilities to work together with the industry in this project. We have learned a lot, and I believe that the industry has also learned a lot from all the academic partners.

So this was to collect big data, and set up an analytic platform based on the innovative tools. So this is the overview of the platform that we have been working on for five years now. We will end it, the work, next year. So first, we made a survey to different stakeholders, patient organizations, key opinion leaders, major centers, other centers, et cetera, to identify the most important questions to address in prostate cancer. And we have list of more than 50 questions, and then we shortlisted about, at least five of them.

And then, we were working on the data sources, to collect all different kind of information from patients, and also them. The big task was here, to handle the data, to harmonize the data. I mean, you can create a big database, but data's been collected different ways in different formats. You need to, and we have image, besides clinical data, we have omics-data, we have images. And so, there is really a need to know exactly how to handle the data and harmonize the data to be able to. And there are a lot of advanced tools that urologists usually don't really understand. But I think we've learned a little bit on why we can use the new tools, and how to collaborate with experts on the data analytics. So as in many other studies, I mean, the outcome would be to make it better for patient, and improve the way we practice evidence-based medicine. And you can find more information on the website here.

This is just an example of, we have I think, at least two million patients now included in different databases here, and the blue boxes here represent data that has been now formatted to be analyzed. And then, we are also still working on some other data sets. And so, this is from many, many different countries, and also from, both from the industry and academic centers. So this is something that we have built for the future.

This is the way how we can work on it. We can put data in the center database, and use different tools there to analyze it. And we can also use the federated method, where data stays behind the firewall at the every center who will contribute, and then, they will be provided with the tools to do the analysis of the data, and then, the results will be exported. And it's up to every reporter to decide whether they want to go for the central or federating model.

And then, now next year, another initiative from James N'Dow, was to continue work on big data, but also add artificial intelligence models to analyze the data. And this would then be together with lung and breast cancer experts. And it was again funded by the European Commission, for a five-year IMI program. And so, we have started to work on this, and the experience from the PIONEER, how to identify gaps of knowledge in the guidelines, and to build big databases, has been transferred to lung and breast cancer expert. And then, we have now included experts on analytics and AI models. So this story about last year, and I think this will be really exciting to see what will come out of it.

This is just an overview of the different partners involved. You see, the industry is multiple companies are here, and many academic big centers are also involved in this. And then other stakeholders, organizations, the patient of course, but also ERTC and other organizations.
So now, the final part will be, what will come next? So again, James N'Dow, he came up with the idea to create what we call the data haven. And this is to collect real world data, try to build real world evidence based on the data, and combine it with what we have learned, and what we're doing within the PIONEER, and with the OPTIMA program. So of course, it will be at the end, better personalized treatment for urology patients. But so this is a little bit outside of the PIONEER OPTIMA, where we will collect real world data from the centers that usually do not have the possibility to contribute much to the big study, the big Phase III trials. And so, that will give us a more broad picture of how patients are treated in different countries, and what we can learn from each other, from countries that are not always have a possibility to participate in the big projects.

And why would real world data be so important? Well, we cannot fill all the evidence gaps by randomized clinical trials. And also, data from these big studies usually come from centers of excellence, which will not always reflect what's going on, and what can be provided for patients in other countries. And then, I think we, evidence-based medicine in the future will also include real world data.

So this is almost my final slide here. This is how we can put everything together in one context in the future. We have the EAU data innovative product, we can call it the data haven, the data service and evidence hub, or whatever. And then, we are already connected to different organizations from different countries, and the PIONEER a OPTIMA or there you see, but also the EAU data space that is being created, but that covers many other diseases.

So I mean, I think we are like pioneers with the project and big data that we have within the EAU today. That is something that can be a template for how the European Commission will work in the European health data space. And also, DARWIN is a little bit similar to the OPTIMA, that the next step you take in how to analyze the data. And EHDEN is another IMI product for big data that will facilitate other products, how to use the new innovative analytic tools. And of course, many more databases can be added to this. So this is how we would like to see it from the EAU perspective in the future.

So the future aims would then be to expand the portfolio. We have what investigator initiated, and we are more than happy to get ideas from the young academic urologist, in Europe, and of course, from other specialties. And at the ESMO meeting recently, I was really happy to see that the young academic urologists are now connected to young ESMO, and young ASCO, et cetera. So it's really important to go multidisciplinary in the future. And not only product, but also, registries. I think in the future, to create many good registries, and then to fully get the knowledge to identify from our guidelines. So big data, really more data, data haven, that is what we would like to focus more in the future.

And I thank you so much for being, giving me the opportunity to talk to you today online, and I'm really sorry I cannot be with you in person and to discuss, because I think the interactions there is really also really important.

So I'll stop here, and thank you so much for your attention.