Background

Clinical trials are a procedure to verify the safety and efficacy of new drugs, while also serving as a pathway for patients to access unapproved therapeutic candidates. In cases of severe or rare diseases with few treatment options, the ability to participate in trials can lead to disparities in medical opportunities. Driven by regulatory reforms and the growth of the biopharmaceutical industry, China has rapidly increased its clinical trial execution capacity over the past decade.

However, an increase in the total number of trials nationwide does not mean patient accessibility improves at the same rate. Operating clinical trials requires skilled researchers, Institutional Review Boards (IRBs), data management systems, and testing/hospitalization facilities. This infrastructure tends to cluster in tertiary medical institutions in large cities. Patients in rural areas must endure long-distance travel, accommodation costs, repeated visits, and gaps in care, even if suitable trials exist. If trial participants are skewed toward certain regions and social classes, the representativeness of the research results is also diminished.

Key Findings

In a commentary published in the international journal Nature Medicine on September 25, 2026, researchers including Liu Yang highlighted the gap between the quantitative growth of China's clinical trial ecosystem and healthcare accessibility. The key finding is that the increased performance capacity over the past decade has been concentrated in top-tier medical institutions. The authors point out that evaluating the expansion of clinical trials solely through increases in registration numbers or the number of institutions may overestimate the actual benefits received by patients.

The authors believe that clinical trial capacity should be treated as a component of healthcare accessibility rather than a performance metric for research institutions. The structure where tertiary hospitals lead complex early-phase and high-risk trials is rational in terms of expertise and safety management. The problem lies in the fact that as patient recruitment, follow-up, sample collection, and even some evaluations are tied to central institutions, the room for participation by regional medical institutions narrows.

This article is a policy commentary analyzing China's clinical trial infrastructure, not a study reporting the efficacy of randomized clinical trials or new therapies. The public abstract does not provide quantitative values such as the number of trials per institution, regional distribution rates, or patient travel distances. It is also not a direct comparison of the effectiveness of specific decentralized clinical trial models. Therefore, the identified conclusion should be read as a structural diagnosis: 'The increase in clinical trials does not necessarily mean improved equitable access, and the growth is concentrated in top-tier institutions.'

Implications and Outlook

If the goal of clinical trial policy shifts from expanding the number of trials to expanding patient reach, the evaluation criteria will also change. Regional recruitment rates, dropout rates, participants' socioeconomic backgrounds, travel burdens, and the proportion of contribution by regional medical institutions must be examined together. Strategies such as referral systems between tertiary and regional hospitals, remote follow-up, standardized data collection, and joint training for research personnel are candidates for expanding the scope of access while maintaining trial quality.

However, decentralizing all trials to local areas is not appropriate. Research requiring immediate response to severe adverse events, such as cell/gene therapies or first-in-human trials, inevitably requires concentration in specialized institutions. Procedures that can be decentralized and those that require centralization should be distinguished based on risk, and the quality control and ethical review capabilities of regional institutions must be enhanced first. China's experience poses the same question to other countries fostering clinical trial hubs. What matters more than the scale of research is which patients actually participate and how far the benefits reach.