Early Clinical Trials Unit

The Early Clinical Trials Unit (ECTU) is a structure created in 2019 by the Medical University of Gdańsk with direct support of the University Clinical Centre in Gdańsk, due to which a better implementation of clinical research for innovative drugs is possible. The aim of the unit is to conduct scientific research assessing the safety and effectiveness of modern therapies in all therapeutic groups, in particular oncological, cardiological and cardiovascular at an early stage of development. This includes phase I / II studies (e.g. dose escalation, drug interactions, food interactions, cardiological safety or proof-of-concept).

Prof. Rafał Dziadziuszko

Prof. Jacek Jassem

In the near future, it is planned to extend the functionality of the ECTU to include studies requiring close monitoring of pharmacokinetics and pharmacodynamics, as well as first-in-human studies (More). Thanks to intensive efforts and appropriate resources, it was possible to meet all the requirements set out in the applicable guidelines (Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products, EMEA/CHMP/SWP/28367/07). Due to the fact that at such an early stage of clinical development, the fastest possible processing of biological material, ECTU has its own laboratory, thus ensuring comprehensive execution of research projects. The necessary access to the intensive care unit, PET, MRI and CT laboratories, the Department of genetic tests, the opportunity of biopsy and surgical procedures as well as the 24-hour care of experienced doctors of each specialization is possible thanks to the location of ECTU in the UCK. ECTU staff is GCP and IATA certified and has undergone training in advanced life support. The Early Clinical Trials Unit is currently developing a quality system for conducting clinical trials – this is the last step to obtain accreditation for early phase clinical trials centers in accordance with international standards (Phase I Accreditation Guidance, Final 28 Oct. 15, Medicines and Healthcare products Regulatory Agency). In addition, in 2016, UCK implemented a modern data analysis system, thanks to which it is possible to quickly and easily search for patients, e.g. on the basis of hospital stays, medical records, laboratory test results, what medications were administered, or what medical procedures were performed. From a base of over 900,000 patients, the ECTU’s researchers will be able to select patients who meet the restrictive inclusion criteria for the study, who could then undergo targeted molecular or immunological treatment in the clinical trial.

The Medical Director of the Unit is Prof. Rafał Dziadziuszko, Head of the Department of Oncology & Radiotherapy of the Medical University of Gdańsk, Head of the Teletherapy Laboratory, while the Chairman of the Scientific Council of the ECTU is Prof. Jacek Jassem, from the Department of Oncology & Radiotherapy of the MUG.

ECTU has established international cooperation with Dr. D. Ross Camidge, Director of the Chest Oncology Department at the University of Colorado, and Dr. Solange Peters, Head of the Medical Oncology Service, Chair of Thoracic Oncology, Oncology Department, Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne. Dr. D. Ross Camidge and Dr. Peters support the Unit with their experience and help in organizing the first academic, multidisciplinary early phase clinical research center in Poland.

photos Paweł Sudara/MUG, Sylwia Mierzewska/UCC