The activity of ECTC (originated from the structure of the Early Clinical Trials Unit) is aimed at conducting clinical research at the early stage of developing innovative therapies, especially in Priority Research Areas of the Medical University of Gdańsk, as defined in the “Excellence Initiative – Research University” Program. These scientific studies evaluate the safety and efficacy of therapies in numerous therapeutic areas, specifically oncology, hematology, cardiology, neurology and connective tissue diseases. Phase I/II studies at ECTC include first-in-human designs with dose escalation, drug interactions, food interactions, cardiovascular safety, close monitoring of pharmacokinetics/pharmacodynamics, among others.
Correct conduct of early phase studies requires the entire research team to work to high quality standards and international principles of Good Clinical Practice, as developed by the International Conference on Harmonization. ECTC staff are certified in good clinical practice (GCP), IATA and have received training in advanced resuscitation procedures. Research conducted under the ECTC is regularly monitored by representatives of the research sponsors and national and foreign institutions established for this purpose.
The Centre, established on the initiative of Prof. Jacek Jassem, aims at substantive reinforcement of research teams at the MUG by supporting the process of building scientific excellence and the international position of the University. ECTC’s scientific and research activities include planning clinical trials based on data from preclinical studies and available clinical data on pharmaceutical products and drugs, as well as consulting on the preparation of and participation in the implementation of early phase studies with external partners, including in particular representatives of the pharmaceutical industry, other universities and academic research groups. The center also conducts translational research in optimizing diagnostic methods for personalized medicine. The activities of ECTC also include education of students, Ph.D. students and staff at the MUG.
ECTC has established international cooperation with numerous foreign institutions (e.g. University Hospital Charite in Berlin, University Hospital Lausanne, Princess Margaret Cancer Centre in Toronto) and partners from domestic and foreign pharmaceutical industry.