Early Phase Clinical Trials Centre (EPCTC) is a research infrastructure established in 2019 by the Medical University of Gdańsk with the direct involvement of the University Clinical Centre in Gdańsk, enabling the conduct of clinical trials of innovative medicinal products. The Centre’s mission is to perform research assessing the safety and efficacy of novel therapies across all therapeutic areas, with particular emphasis on oncology, cardiology and cardiovascular medicine at early stages of development. This includes Phase I and Phase II studies such as dose-escalation trials, drug–drug interaction studies, food-effect studies, cardiac safety assessments and proof-of-concept trials.
In the near future, the EPCTC plans to expand its capabilities to include studies requiring intensive pharmacokinetic and pharmacodynamic monitoring, as well as first-in-human clinical trials. Through significant investment and development efforts, the Centre has fulfilled all requirements outlined in the applicable European guidance: Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products (EMEA/CHMP/SWP/28367/07).
As rapid processing of biological samples is essential at such an early stage of clinical development, the EPCTC operates its own laboratory facilities, ensuring comprehensive delivery of research projects. Access to intensive care units, PET, MRI and CT facilities, genetic testing laboratories, biopsy and surgical procedures, as well as round-the-clock support from experienced physicians across all medical specialties, is available thanks to the Centre’s location within the University Clinical Centre.
EPCTC personnel hold GCP and IATA certifications and have completed advanced life support training. The Centre is currently implementing a comprehensive quality management system as the final step towards obtaining international accreditation.
In addition, in 2016 the University Clinical Centre implemented an advanced clinical data analysis platform that enables rapid identification of patients based on treatment history, laboratory results and therapies received. From a database of more than 900,000 patients, researchers can efficiently identify individuals meeting clinical trial eligibility criteria.
Prof. Rafał Dziadziuszko
Prof. Rafał Dziadziuszko
Medical Director of the Centre; Head of the Department and Clinic of Oncology and Radiotherapy, Medical University of Gdańsk.
Prof. Jacek Jassem
Prof. Jacek Jassem
Chair of the EPCTC Scientific Advisory Board.
The EPCTC has established international collaborations with Dr D. Ross Camidge (University of Colorado) and Dr Solange Peters (CHUV Lausanne). These experts support the development of Poland’s first academic, multidisciplinary early phase clinical trials centre.
Photos: Paweł Sudara/MUG and Sylwia Mierzewska/UCK
Contact
Prof. Rafał Dziadziuszko
rafal.dziadziuszko@gumed.edu.pl