Access to clinical trials for soft tissue sarcoma patients in Western and Eastern Europe

Abstract

Background: Soft tissue sarcomas are a rare subgroup in adults and children with oncological diseases. Since the 1970s, after the introduction of doxorubicin as a chemotherapeutic agent for the treatment of soft tissue sarcoma, the treatment of metastatic and primary localized sarcoma has remained weak, although several new therapeutic agents have been identified in this time. Participating in clinical trials can help solve this problem in general and particularly in countries with a low level of access to innovative medicines. We performed qualitative and quantitative comparative analysis of clinical trials for soft tissue sarcoma patients in Western and Eastern Europe. Methods: Based on data from https://clinicaltrials.gov/ we searched for clinical trials that have been performed in 2009-2019 in 30 European countries (10 in Western and 20 in Eastern countries). Clinical trials by phases, type of therapy, soft tissue sarcoma type, stage of disease and status were studied. Results: The vast majority of soft tissue sarcoma trials have been performed in Western Europe (401/467) and of those 212/52.9% of were phase II; average number of trials per country was 40, ranging from 30 (Switzerland) to 92 (France). In Eastern Europe the average number of trials per country was 3 with a maximum of 23 (Poland); 45.5% of trials were phase III. Clinical trials in adults (> 18 years) in Eastern Europe and Western Europe (78.8% vs 75.3%), in patients younger than 18 years (21.2% vs 24.7%), respectively. For soft tissue sarcoma stages I-II, III, (unresectable)/IV 1.0, 17.5 and 81.5% trials, respectively, have been held in Western Europe, 0, 18.2 and 81.8% trials in Eastern Europe. The most frequent clinical trials studies of targeted therapy, chemotherapy and combination treatment, constituting 35.9%, 20.4% and 17.2% trials in Western Europe and in 18.2%, 27.3% and 16.7% trials in Eastern Europe, respectively. Only 14.1% of trials are currently recruiting patients in Eastern Europe while 85.9% of recruitment is in Western Europe. Conclusions: Access to clinical trials for soft tissue sarcoma patients in Western and Eastern Europe is quite different. Participation in clinical trials could help as patients from countries with low access to innovative medicines or oncologists could get necessary experience. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.