The single center experience with the war-related Ukrainian patients with various cancer diagnoses treated in clinical trials between 2022-2024.

Abstract

e23040 Background: According to the WHO, 32% of active combat areas residents have been unable to obtain essential medicines since the beginning of the war in Ukraine. Clinical trials conducted in Poland have proven to assist oncological patients greatly. Many Ukrainian residents have Polish ancestors and are fluent in the Polish language. We decided to check whether the highest ethical standards of clinical trials make the ordinary intention to include a patient from Ukraine insufficient. Conducting a complete risk-benefit analysis allows choosing the best interest and safety of the clinical trial participant. Methods: The study aimed to evaluate the most frequent standards of oncological treatment of Ukrainian patients. We retrospectively verified the number of patients of Ukrainian nationality, in the age above 18 years treated at our center since the start of the invasion of Ukraine in February 2022 compared to the Polish patients. Results: Based on the National Health Fund data, Polish cancer centers in 2022 treated overall 994,767 patients including 8,000 patients from Ukraine. In the Pomeranian region, 3,815 patients received oncological therapies (data from the Central Statistical Office - of national). At our center in Gdansk between 01.01.2022 and 31.12.2023, therapy received 38,574 patients, including 34 Ukrainians. Clinical trials participants included 3,968 Polish and four Ukrainian patients (2 cases of malignant melanoma, one breast cancer, one lung cancer). Ukrainian patients represented 28.5%, 10%, and 8% of all patients included, respectively. Conclusions: Not prepared for the rapid influx of migrants Polish healthcare system encountered many problems like the language barrier, the need for a translator or approved documents by the Bioethics Committee, and the legal side of the informed consent form (ICF). At our center, all Ukrainian patients signed ICF in Polish. Regarding clinical trials participation, our study shows the unmet need of Ukrainian patients. The decision to include a patient has to be mutual (sponsor and investigator) and as soon as possible to ensure the required safety of each patient.