Time to focus on a partner organisation of PRESTIGE-AF. Collaborating in a major, pan-European research project is no small feat. Our partners are what make the research come to life, and it is only fair to regularly bring under the spotlight, the dedicated and passionate researchers behind PRESTIGE-AF. The ‘partner in focus’ this time around is Universitaetsklinikum Wuerzburg (UKW). Located in Germany, UKW is closely linked with The University of Würzburg and its Medical Faculty as clinics, preclinical and clinico-theoretical institutes work together closely in the field of science and research.
What does it mean for you and your team to be part of this EU-funded project? What are the highlights? The challenges?
Stroke is one of the most frequent causes of death, and its prevention presents a considerable challenge for research. The PRESTIGE-AF trial brings together top-ranking researchers in the field of stroke research and is precisely working on this challenge. The fact that the EU funds the PRESTIGE-AF trial makes it possible to pool capacities of all consortium partners for such research efforts. The collaborative effort of all contributing parties, in particular, enabled us to develop new scientific and innovative ideas, which are realised in the form of PRESTIGE-AF substudies, and represent a highlight of the project. Through the cooperation, the consortium partners benefit from each others’ expertise, which also gives us the opportunity to look at situations from a different perspective. This unique opportunity to cooperate with many partners at the same time also represents a challenge, as it demands great communication skills to consider each partner’s ideas. It is an exceptional opportunity for us to be part of such an amazing international research collaboration.
Tell us more about your team working in PRESTIGE-AF. Who are they and what are they working on?
Our team at the University Clinics Wuerzburg (UKW) includes project managers, data managers, and biostatisticians. With professionals from different areas and years of experience conducting clinical trials, we support the Sponsor Imperial College as Clinical Trial Support Center in the implementation, execution, and completion of the PRESTIGE-AF trial providing support in the areas project management, data management, monitoring, as well as biometrics. Our project management activities include, among others, regulatory advice, development of documents, and execution oversight. Besides project management support, the development of a validated database system in compliance with the ICH E9 guideline and other regulatory requirements is one of our central tasks, so that valid data can be provided for analysis at the end of the trial. During the course of the trial, we will oversee clinical monitoring in France, UK, Italy, and Spain, and will monitor the sites in Germany and Austria. We also developed the statistical analysis plan, perform the final statistical analysis at the end of the trial, and participate in the Steering Committee. Therefore, our project management team, our data management team, and our statistician are involved in PRESTIGE-AF trial and working closely together with the sponsor and the consortium partners.
How did UKW get involved in PRESTIGE-AF2020?
As Clinical Trial Support Center of the UKW, we focus specifically on the conduct of investigator-initiated clinical trials. Due to previous cooperation with the project coordinator and the Institute for Clinical Epidemiology and Biometry (ICE-B) of the University Wuerzburg, it was obvious to bring in our expertise in the PRESTIGE-AF trial as well.
What is UKW main motivation to participate in international collaborations such as PRESTIGE-AF2020?
Our goal is to accompany the project partners throughout all steps of the clinical trial and to enable the successful start-up, execution, and completion of the trial. It drives our motivation that PRESTIGE-AF allows us to learn from partners in other countries, to gain a deeper insight into their processes and structures, to exchange experiences, and develop innovative ideas together. The new contacts with the consortium partners are also of great value for possible future collaborations in the clinical field at the end of the PRESTIGE-AF trial. We live Europe, through such projects.