Global inequities in sarcoma clinical trials: A comprehensive analysis over the last decade.

Abstract

11575 Background: Sarcomas are rare, comprising 15% of childhood cancers and 1% of adult cancers, yet survival rates remain poor. The overall 5-year survival for soft tissue sarcomas (STS) is 65%, dropping from 81% for localized disease to just 16% for metastatic cases. For bone sarcomas, survival declines from 84% at localized stages to 31% for metastatic cases. This highlights the critical need for novel therapies and equitable research access. To address this, the current review discusses sarcoma clinical trials conducted over the past decade. Methods: Sarcoma-related clinical trials registered on ClinicalTrials.gov from 2016 to 2025 were analyzed. Variables included study status, conditions, phases, randomization, dates, country, age groups, sample size, sponsor, and reasons for discontinuation. Geographic data were categorized by World Bank income levels. Descriptive statistics summarized key characteristics. Results: Out of 1,232 studies, 65% were focused exclusively on sarcomas. Alarmingly, only 0.4% of the studies were conducted in low-income countries (LICs) and only 18% in low- and middle-income countries (LMICs), underscoring a profound underrepresentation of these regions in sarcoma research. Recruitment status varied, with 39% of trials actively recruiting, 18% completed, and 14% terminated—predominantly due to challenges in participant accrual. Early-phase trials predominated, comprising 34% in phase 1 and phase 1/2, and 30% in phase 2. Late-phase and post-marketing studies were sparse, representing only 5%. Interventional trials accounted for 82% of the total, though most lacked randomization. The majority of studies (72%) were academia-sponsored trials. Only 1% of studies were exclusively dedicated to pediatric populations, while 36% included both adults and children, and 63% enrolled adults exclusively. The median sample size was 46 participants (IQR 22–117), and the median study duration was 47 months (IQR 29–70). There are no trend changes in the number of studies that were launched from 2016 to 2024. Conclusions: Our study highlights inequities in the geographic distribution of sarcoma trials, and the substantial neglect of LICs and pediatric populations. This underscores an urgent need for global efforts to address these disparities and enhance inclusivity in clinical research.