Early-phase drug development in oncology: Geography of trials including US vs China.

Abstract

e23049 Background: Early-phase oncology drug development is predominantly driven by industry sponsors and spans multiple regulatory regions. A characterization of clinical trial activity and features across different regions is important to understand the impact of recent regulatory shifts put in place to facilitate early-phase clinical trials and increase each region’s competitiveness in a global environment. We aim to analyze whether in the last 2 years early-phase oncology trials regional distribution has changed. Methods: We conducted a retrospective analysis of early phase (Phase I, I/II, II and II/III) interventional oncology trials registered on ClinicalTrials.gov (ct.gov) with start date between January 1st, 2024 and December 31st, 2025. Oncology trials were defined by certain keywords were filtered on ct.gov. Trial patterns were assessed using ct.gov reported characteristics, including geographic scope (single vs multi-country participation) and number of sites (small [1–5 sites], medium [6–10 sites], or large [ > 10 sites]). Regional comparisons were made focusing on China vs US. Comparisons across subgroups were evaluated using chi-square test for categorical variables, with an alpha level of 0.05. Results: Among 2,345 oncology trials meeting inclusion criteria, 1,713 (73.1%) were industry-sponsored, with comparable representation from China (50.5%) and the US (49.0%). Among industry-sponsored Phase I trials, the distribution of single-site versus multi-site designs differed markedly between China and the US (p < 0.00001), with trials including China more frequently single-country (242, 63.0%) and trials run in the US predominantly multi-country (195, 82.3%). Operational scale also differed significantly, with trials including China more commonly limited to small groups and trials including US more frequently expanding to medium and large site counts (China vs US; small 319 (79,4%) vs 142 (35,4%), medium 27(6.7%) vs 102(25.4%), large 25 (13%) vs 138 (34.4%)) (p < 0.00001). These regional design patterns persisted across development stages. More than 80% of US-based industry-sponsored trials were multi-country across all phases, whereas trials including China remained predominantly single-country, with increased multi-country participation observed only at the Phase II/III stage. The China–US difference in geographic scope remained highly significant when all trials were analyzed, including academic and hospital-led studies (p < 0.00001). Conclusions: Early-phase oncology trials demonstrate consistent regional differences in observable design patterns across development stages. Among industry-sponsored programs, trials including China and US differ markedly in geographic scope, operational scale and expansion strategy, with these patterns persisting across phase I and II trials. These findings describe distinct regional approaches to early-phase trial design.