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E.O.E Newsletter | www.huanet.gr
In going together, there is a need to work as a team, one family, leveraging complementarities within national structures and national societies, and critically, across the global urological community as a whole to the maximum towards this worthy purpose. We must commit to making (and evidencing) a positive difference to the lives of patients and their families with any and all of our educational and training activities. At the EAU, we are pleased to be entering a new era of evolution at the European School of Urology (ESU) led by well-respected Greek Urologist Prof. Dr. Evangelos Liatsikos; I am confident that Prof. Liatsikos will oversee this evolution with dedication, inclusivity and compassion. He continues the great work that Prof. Dr. Joan Palou did in the previous 8 years in building a very strong European School of Urology.
The PIONEER/OPTIMA projects aim to ensure optimal care for European cancer patients. Tell us more about these two projects.
A key ambition of the EAU Guidelines Office has always been to use the best evidence available to underpin guideline recommendations. It soon became clear that the quality of the majority of published evidence was unsatisfactory to underpin recommendations. We needed to look for innovative ways to fill the gap. The use of big data was one such option. However, to do so would require significant funding. With the EAU’s support in partnership with its Research Foundation, the Guidelines Office put together a strong consortium to secure €12M-funding from the European Commission’s Innovative Medicines Initiative (IMI) to collate the best and largest PCa datasets from within and beyond Europe. We feel fortunate to have had the privilege of working with patients, PCa specialists, scientists, epidemiologists, big-data analytics experts, ethicists, and Health Technology Assessment (HTA) experts. We are learning everyday about the exciting opportunities presented by use of real world data especially the complementarities it brings alongside traditional published clinical trials. We have long recognised that clinical trials often do not have participants that have multiple comorbidities, on multiple drug treatments, the elderly, or the obese; but yet still we apply the findings of such clinical trials (without evidence of effectiveness) to these sub-populations.
Equally, published patient outcomes from centres of excellence are not necessarily generalisable to all other centres when the majority of patients are cared for by urologists in hospitals that are not recognised as centres of excellence. Also, real world data allows us to better understand longterm outcomes especially adverse effects. It is in such areas that real world data truly brings complementarities to clinical trials. There is still much for urologists to learn however in the methods of real world data analytics to ensure we as a global community gain enough confidence is the estimates we get from real world data. It is no longer a question of whether we should be in this new arena, the question should be why it has taken us this long to be brave enough to embrace it and start learning together. To learn more about PIONEER, please see the following https://prostate-pioneer.eu/. In June 2021, we received confirmation of a €21.3M-funding from the European Commission’s Innovative Medicines Initiative for another Big Data project called OPTIMA, this time focussing on prostate, breast and lung cancers whereby Clinical Practice Guidelines are interfaced with Electronic Health Records and real-world data powered by Artificial Intelligence, if necessary. The OPTIMA consortium is also coordinated by the EAU. OPTIMA intends to help us individualise care for our patients. To learn more about OPTIMA, please see the following https:// www.optima-oncology.eu/.
The era of real-world data-based medicine is beginning however, not all countries are ready for it. As healthcare systems vary across the globe and well-structured local and central databases are lacking, this eventually will lead to a two-speed RWD world. How is the EAU planning to address this issue and offer guidance to national urological associations?
It is true that different countries and different hospitals are at different stages of preparedness for capturing real world data. The EAU has thankfully learnt a lot over the past 4 years including how to harmonise different data sources by mapping to a Common Data Model (CDM), the preferred CDM being the Observational Medical Outcomes Partnership (OMOP). Importantly, the EAU has learnt how to manage data sharing using a central model (where data is shared to a central
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