Early Clinical Trials Unit
Early Clinical Trials Unit (ECTU) is a structure established by MUG in 2019 with direct involvement of UCC. Because of ECTU, it is possible to complete clinical research on innovative drugs. The purpose of the ECTU is to succeed scientific research to assess the safety and effectiveness of up-todate therapies in all therapeutic groups, including but not limited to oncological and cardiologic as well as cardiovascular ones at an early development phase. They include phase I/II research (for example, dose escalation, drug interactions, interactions with food, cardiologic safety, and proof-of-concept). In the close future, the functionalities of ECTU will be extended with research that require close monitoring of pharmacokinetics and pharmacodynamics as well as first-in-human research. Owing to the intense exertion and sufficient outlays, all requirements given in applicable guidelines have been fulfilled (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 biological material has to be processed as soon as possible, ECTU has its own laboratory that guarantees the comprehensive presentation of research projects. Moreover, the necessary access to the intensive healthcare sections as well as PET, MRI and TC laboratories, the genetic study laboratory, the option to carry out biopsies and surgeries and full-time care of experienced medical consultants in all fields are possible owing to the location of ECTU at UCC.
The staffs of ECTU have GCP and IATA certificates and underwent training in advanced resuscitation procedures. The centre is generating a quality system for clinical trials, which is the last step in obtaining an accreditation for an early phase clinical trial centre according to international standards (Phase I Accreditation Guidance, Final 28 Oct 15, Medicines and Healthcare products Regulatory Agency). Moreover, UCC implemented a modern system for data analysis in 2016, which enables the fast and easy search for patients, for example based on hospital admissions, doctor’s comments, laboratory test results, medicine administered, and medical procedures performed. Out of the base of more than 900 thousand patients, researchers of the Centre will be able to select those who fulfil restrictive admission criteria for trials and will be subjected to a therapy in a clinical trial with a molecular or immunological focus.
photos Sylwia Mierzewska/UCC
The medical manager of the Centre is Prof. Rafał Dziadziuszko, Deputy Head of the Department and Clinic of Oncology and Radiotherapy of the Medical University of Gdańsk, and Head of the Radiotherapy Laboratory, while the Chairman of the Scientific Council of ESCRC is Prof. Jacek Jassem, Manager of the Department and Clinic of Oncology and Radiotherapy, MUG.
ECTU has initiated international cooperation with Dr. D. Ross Camidge, Director of the Thoracic Oncology, University of Colorado, and Dr. Solange Peters, Director of Clinical Oncology Department, Head of Oncology Departments of Lungs and Surgery of Chest, Vaudois University Hospital (CHUV) in Lausanne. Dr. Camidge and Dr. Peters support ESCRC with their experience and assistance in organising the first in Poland academic, interdisciplinary unit of early clinical trials.