MCWBK of the MUG, UCC and UDC officially open

3.03.2023

Over 10 million PLN was awarded to the Medical University of Gdańsk for the creation of the Multi-disciplinary Clinical Research Support Centre (Multidyscyplinarne Centrum Wsparcia Badań Klinicznych, MCWBK) as part of the first competition of the Medical Research Agency (Agencja Badań Medycznych, ABM) for the creation and development of Clinical Research Support Centres (CWBK). The funds enabled the creation of the necessary infrastructure and the development of the Centre’s staff. The project will be implemented from 2021 to 2026.

The official opening of the unit took place on 3rd of March 2023. The event was attended by: Rector of the MUG Prof. Marcin Gruchała, Deputy Minister of Health Piotr Bromber and President of the Medical Research Agency Dr. Habil. Radosław Sierpiński together with the director of the Clinical Research Development Centre of MRA Agnieszka Ryniec. The ceremony was honored by the presence of, among others: Deputy to the Sejm of the Republic of Poland Elżbieta Gelert, Member of the Board of the Pomeranian Voivodeship Agnieszka Kapała-Sokalska, Deputy Mayor of Gdańsk Monika Chabior, Director of the Pomeranian NHF Monika Kasprzyk and Director of the Director of the PUW Health Department Jerzy Karpiński, Ph.D. Also present were: representatives of the University Authorities, the Senate and the University Council, General Director of the Univeristy Clinical Centre (UCC) Jakub Kraszewski, President of the University Dentistry Centre (UDC) Mirosława Pellowska-Piontek, Ph.D., as well as Heand of the partner units’ Clinical Research Support Centres – Head of the MUG’s CWBK Office Prof. Piotr Widłak and UCC Director’s Plenipotentary for CWBK Dr. Habil. Tomasz Stefaniak. There were also the main researchers and research teams implementing projects financed by MRA and employees of MCWBK from the MUG and UCC.

− The essence of the operation of medical universities, apart from educating staff, is to conduct research in the field of medical sciences, in particular clinical trials. You can’t do medical research just sitting behind a university desk. For this, a professional tool is needed, which are clinical hospitals, medical entities, on whose territory and with, thanks to the infrastructural, organizational and human resources, this type of research can be conducted at all − emphasized Prof. Marcin Gruchała, Rector of the Medical University of Gdańsk.

As the Rector of the MUG pointed out, clinical trials often represent a great opportunity for many patients with severe diseases, saving their lives and enabling access to innovative, extremely modern therapies that are not yet available as part of standard treatment.

− I would like to thank our researchers who carry out these difficult projects for our University, for the development of medical science and for the benefit of our patients − added Rector Marcin Gruchała. − I would also like to thank our partners in this project − the University Clinical Centre, which is not only a hospital that helps patients, but is an extremely important centre for scientific research, and the University Dental Centre, which is also an extremely important partner for the University in this respect.

The Medical University of Gdańsk is one of the most active applicants receiving funding from the Medical Research Agency. Currently, the University is the leader of 16 projects financed by ABM, among which 15 are research and scientific projects, and one concerns the creation of a Multi-disciplinary Clinical Research Support Centre. The total value of the co-financing is over PLN 201 million.

Over PLN 10 million of state funding from the Medical Research Agency was allocated to: adapting and equipping approximately 20 office rooms, equipping the Early Phases Clinical Trials Centre with medical equipment, as well as creating an IT system for managing clinical trials and employing staff.

The MCWBK is a unit that comprehensively supports the implementation of clinical research projects, financed from research funds awarded in a competition mode, and organizes the implementation of clinical trials commissioned by other commercial and academic entities. Thanks to the support provided by ABM, MCWBK will facilitate the implementation of new highly specialized commercial and non-commercial clinical trials at the Gdańsk research and clinical centre, often not carried out in Poland so far.

− This is an important period when it comes to clinical trials in Poland. A few years ago, the Medical Research Agency was established, and I hope that next week the legislative process in the Sejm regarding the Clinical Trials Act will be completed. We are closing an important process, an important stage of supporting the clinical trials process in Poland. We are creating a completely different space for this research, modern and transparent, which is important in the entire legislative process − noted Deputy Minister of Health Piotr Bromber. − Congratulations, Rector, on opening this Centre. I hope that there is another impulse to carry out clinical trials at the Medical University of Gdańsk, which is extremely important for us as the Ministry.

The Multi-disciplinary Clinical Research Support Centre of the Medical University of Gdańsk, the University Clinical Centre and the University Dental Centre (MCWBK of the MUG, UCC and UDC) was established to create an effective structure dealing with comprehensive service and management of clinical trials and medical experiments, including research experiments, launched at the MUG. The unit’s tasks also include supporting clinical trials conducted at the UCC and UDC. The MCWBK consists of Clinical Research Support Centres (CWBK) existing within the structures of the relevant partner units. These are respectively: in case of the MUG – CWBK Office, in case of the UCC – CWBK-UCK and CWBK-UCS in case of the UDS.

− Today, Gdańsk joins the elite group of the best universities in Poland, which conduct research at the best European level, and perhaps − I am not afraid to say it − at the best world level − said the President of the Medical Research Agency Dr. Habil. Radosław Sierpiński. − This is a great celebration of the Medical University of Gdańsk, but also of patients, because clinical trials often provide access to modern, wonderful therapies in many diseases, which are a chance for a longer, better life. When we were creating the Agency, when together with the Ministers we were thinking about what we could do to improve the infrastructure in Poland and we were looking at what was done in Gdańsk − the Early Phase Clinical Trials Centre opened in 2019 and the organization of clinical trials in the hospital in order to this model should be properly applied throughout Poland.

As the President of ABM added, over the last 4 years of operation, the Agency has allocated over PLN 2 billion to the clinical trials sector in Poland, including several hundred projects involving over 60,000 patients, who all over Poland take part in research financed in this way by the treasury countries.

− We meet to open 15 out of 23 Clinical Trials Support Centres. We are talking about a network, about a certain brand and quality that we are building in Poland − said President Sierpiński. − Clinical trials are, in a sense, a science-enhanced state-of-the-art therapy. This is what we do, thanks to such activities and this support, we can help patients in the best possible way. What makes me very happy is the fact that in a sense the idea of creating the Clinical Trials Centres was born here in Gdańsk.

Under the MCWBK, support for innovative research infrastructure is planned, including the Early Clinical Trials Centre, where scientific projects will be carried out in cooperation with the best scientific institutions in the world. MCWBK also plans to participate in the education of students and doctors. Thanks to the support of the MUG’s research teams by MCWBK, the University will increase its participation in pioneering research on new drugs, without which the development of medicine is impossible.

− This Centre is an example of the fact that using certain ideas and enthusiasm, you can realize dreams that in principle have never been possible to realize. These ideas, these are very early ideas that give you an amazing perspective. If we do not check what is beyond this horizon, we will not discover a new land. And all this, the Centre and the projects give such an opportunity − emphasized Jakub Kraszewski, General Director of the UCC.

As Mirosława Pellowska-Piontek, Ph.D., President of the UDC of the MUG, pointed out, it is the only Clinical Research Support Centre in the country that includes a dental centre. There is a huge technological progress in dentistry, and the inclusion of the unit in the MCWBK structure creates new opportunities for its development and the implementation of unique clinical trials in this area.

During the ceremony, there was organized a short session Non-commercial clinical trials – opportunities and challenges, during which MUG’s researchers implementing clinical projects financed from MRA – Prof. Piotr Czauderna, Head of the Department of Surgery and Urology for Children and Adolescents, Prof. Jan Maciej Zaucha, Head of the Department of Haematology & Transplantology and Jarosław Meyer-Szary, Ph.D. from the Department of Paediatric Cardiology and Congenital Heart Defects.

The opening of the MCWBK of the MUG, UCC and UDC was preceded by the workshop Start-up of a non-commercial clinical trial – the role of the Academic CRO, which was conducted on 2nd of March 2023 by Damian Świeczkowski, Ph.D., Head of the Department of Academic CRO of the MUG.

NON-COMMERCIAL CLINICAL TRIALS CONDUCTED BY THE MUG THANKS TO MRA FINANCING

• ADONIS-PCI Dual antithrombotic therapy with Dabigatran and Ticagrelor in patients with Acute Coronary Syndrome and Non-valvular Atrial Fibrillation undergoing percutaneous coronary intervention, principal investigator: Prof. Miłosz Jaguszewski (1st Department of Cardiology), co-financing value PLN 13.180 million
• ERICONS Early treatment with rituximab in children with idiopathic nephrotic syndrome, principal investigator: prof. Aleksandra Żurowska (Department of Paediatrics, Nephrology and Hypertension), co-financing value PLN 11.960 million
• RAFTING-2019 Radiation-free therapy for the initial treatment of good prognosis early non-bulky HL, defined by a low metabolic tumor volume and a negative interim PET after 2 chemotherapy cycles, principal investigator: Prof. Jan Maciej Zaucha (Department of Haematology & Transplantology), co-financing value PLN 19.859 million
• MeDMD Evaluation of the effectiveness of metoprolol in the prevention of cardiomyopathy and cardiac death in patients with Duchenne muscular dystrophy, principal investigator: Dr. Habil. Joanna Kwiatkowska (Department of Paediatric Cardiology and Congenital Heart Defects), co-financing value PLN 17.904 million
• STROACT Pharmacological reperfusion treatment of ischemic strokes in patients taking oral anticoagulants, principal investigator: Prof. Bartosz Karaszewski (Department of Neurology), co-financing value PLN 20.795 million
• COVID Phase III clinical trial evaluating the effectiveness and safety of Avigan (favipiravir) compared to standard care in accordance with the current AOTMiT recommendations in patients with SARS-COV-2 infection, principal investigator: Dr. Habil. Tomasz Smiatacz (Department of Infectious Diseases), co-financing value PLN 3.4 million
• CAREGIVER Cyclin-dependent kinase in triple-negative breast cancer – a “window of opportunity” study, principal investigator: Dr. Habil. Elżbieta Senkus-Konefka, Assoc. Prof. (Department of Oncology & Radiotherapy), co-financing value PLN 17.436 million
• N-BURGUND Nivolumab (N) with subsequent chemotherapy: bendamustine, gemcitabine and dexamethasone-BGD with autologous bone marrow transplantation in patients with first-line refractory Hodgkin’s lymphoma, principal investigator: Prof. Jan Maciej Zaucha (Department of Haematology & Transplantology), co-financing value PLN 17.117 million
• WHARTON Evaluation of the impact of Wharton’s jelly mesenchymal stem cells preparation in the treatment of fibrosing interstitial lung diseases, principal investigator: Beata Wajda, Ph.D. (Division of Pulmonology), co-financing value PLN 12.514 million
• MARFAN Evaluation of the effectiveness of valsartan in combating aortic dilatation in children and young adults with genetic diseases of the thoracic aorta of the Marfan syndrome type – a multicenter, randomized, double-blind, placebo-controlled study, principal investigator: Lidia Woźniak-Mielczarek, Ph.D. (Department of Paediatric Cardiology and Congenital Heart Defects), co-financing value PLN 9.682 million
• POLPHITT Clinical trial in children and adolescents with primary malignant liver cancer – hepatoblastoma and hepatocarcinoma, principal investigator: Prof. Piotr Czauderna (Department of Surgery and Urology for Children and Adolescents), co-financing value PLN 6.117 million
• SERTRALIN Effect of sertraline on anxiety-depressive symptoms, endothelial dysfunction and biomarkers in patients with heart failure with preserved ejection fraction, principal investigator: Prof. Paweł Zagożdżon (Division of Hygiene & Epidemiology), co-financing value PLN 9.944 million
• WAKE-IN Treatment of acute ischemic strokes caused by occlusion of a large vessel by mechanical thrombectomy in patients with unknown time of onset or who do not meet the criteria for CT qualification (ASPECTS < 6) based on MRI criteria, principal investigator Prof. Bartosz Karaszewski (Department of Neurology), co-financing value: PLN 9.996 million
• TRIMETAZIDINE Effect of trimetazidine on endothelial function and biomarkers correlating with prognosis in heart failure with preserved ejection fraction, principal investigator: Prof. Leszek Kalinowski (Department of Clinical Analytics), co-financing value: PLN 9.999 million
• LEVOTAKO A Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Levosimendan Therapy in low ejection fraction Takotsubo Syndrome, principal investigator: Prof. Miłosz Jaguszewski (1st Department of Cardiology), co-financing value: PLN 11.273 million

More information on the abovementioned projects can be found on the website https://clinicalresearch.mug.edu.pl/.

photo Paweł Sudara/MUG