China Surpasses US in Single-Center Phase 3 Cancer Trials, Expands Drug Development Share

China has surpassed the United States in the number of single-center Phase 3 cancer clinical trials conducted, with 624 Phase 3 cancer trials accounting for 48.5% of the global total. An international joint research team analyzed 1,237 Phase 3 cancer clinical trials registered in the National Institutes of Health clinical trial registry system "ClinicalTrials.gov" and pre-released study results on February 10 on the preprint server "medRxiv."

The analysis showed that while the United States ranked first in the number of research institutions with 2,626 institutions or 39.6% of the total, China had only 464 institutions accounting for 7%. The United States leads in the number of institutions, while China leads in the number of trials.

The most notable feature of clinical trials in China is the high proportion of "single-center Phase 3" studies, in which a single large hospital independently handles everything from patient enrollment to trial operations. Of the 572 single-center Phase 3 cancer trials worldwide, 398 were conducted in China, accounting for 70%. Unlike the United States and Europe, which recruit patients in a decentralized manner through multi-center and multi-country collaboration, China concentrates clinical trials in large tertiary hospitals with a large patient pool.

The research team interpreted this as the result of strategic investment in large research institutions. They explained that this structure accelerates clinical trial timelines and enables multiple Phase 3 trials to be conducted simultaneously, which in turn is linked to an increase in the number of new drug approvals.

China is building its biotech capabilities at the national level. Since the 2015 reform of the drug review system, it has significantly shortened clinical trial approval procedures and expanded the number of nationally designated clinical trial hospitals to more than 1,000. As a healthcare system that concentrates patients in large tertiary hospitals has combined with national research and development support, an ultra-large infrastructure capable of conducting single-center Phase 3 trials has been established.

In 2024, the total number of clinical trials registered in ClinicalTrials.gov from China exceeded 7,000, surpassing the United States. China's share in the global innovative new drug pipeline has risen to around 30%. Last year, the value of technology exports exceeded 40 billion dollars, marking a successful transition to a country that exports pipelines.

As of 2025, China's share of global drug development has risen to 20%, with a pipeline of investigational new drugs that now accounts for approximately 30% of the world's total.

In the study, Korea accounted for 2.3% of the total, with 13 single-center Phase 3 cancer trials. Seven Korean institutions were included among the top 100 large research institutions, indicating that the competitiveness of individual hospitals is high. However, because trials are structurally dispersed across multiple institutions, the proportion of single-center trials is relatively low. Experts point out that, to supplement single-center trial capabilities, it is necessary to build hub-type platforms that link clinical data and patient resources across hospitals.

Currently, the Korea National Enterprise for Clinical Trials and the Korea Drug Development Fund respectively handle infrastructure support and project-based R&D functions, but the country is viewed as lacking a permanent network that integrates and manages hospital clinical capabilities. There have been collaborative cases such as the COVID-19 infectious disease clinical consortium, but these remained limited to specific diseases and project units and did not develop into a structure for jointly conducting large-scale clinical trials.