60MO - Global trends in ongoing sarcoma clinical trials: Disparities and efficiencies

Background

This abstract examines global sarcoma clinical trials from ClinicalTrials.gov, focusing on phase distribution, regional coverage, and sponsorship. Highlighting the need for broader access, it details disparities in trial availability, especially in high-income regions, and the crucial role of international collaboration in addressing the challenges of this rare disease.

Methods

This analysis utilized data sourced from ClinicalTrials.gov, focusing on interventional clinical trials termed ‘Sarcoma’ or ‘Soft Tissue Sarcoma’. The selection criteria were confined to trials that are currently in the phases of recruitment, either “Recruiting” or “Not yet recruiting,” and are in the developmental stages of phase 1/2, 2, 2/3 or phase 3. The search was limited to studies initiated within the decade spanning from January 1, 2015, to January 1, 2025, to reflect recent and ongoing research efforts.

Results

The analysis encompassed 258 ongoing interventional sarcoma trials globally, distributed across phases as follows: phase 2 with 150 trials (58%), phase 1/2 with 82 trials (32%), phase 3 with 23 trials (9%), and phase 2/3 with 3 trials (1%). In terms of geographic distribution, the United States leads with 92 trials, heavily focusing on early-phase research, which constitutes 42% of all early-phase trials globally. Europe shows a split in trial activity, with 82% of Western European countries and only 35% of Eastern European countries hosting trials. France, Spain, and Italy are the most active in Europe with 42, 25, and 23 trials respectively. Collaborative trials include 10 between North America and Europe and 7 involving North America and Asia. Asia demonstrates the most efficient trial durations, averaging 1311 days for later-phase trials, significantly quicker than the global average of 2320 days. 62 were industry-sponsored trials, of which 17 are solely in the USA, 14 are global collaborations, and 10 are based in Asia.

Conclusions

Sarcoma trials focus heavily in high-income areas like the USA, Asia and Western Europe. The USA leads early phases with strong support and infrastructure, while Asia excels in fast recruitment. No LMIC involvement shows critical access gaps, highlighting the urgent need for globally inclusive trials.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.