The United States is right to worry about losing ground to China in clinical research. But if Washington frames trial reform mainly as a race, it risks missing the larger prize: a faster, safer and more trusted model for developing medicines that the rest of the world can rely.
The Food and Drug Administration’s (FDA) new pilot program, part of a broader Department of Health and Human Services effort, aims to accelerate early-stage trials and could shorten development timelines by six to 12 months.
It responds to a real shift. More early drug research has moved overseas — to China, but also to countries such as Australia — where companies cite lower costs, faster regulatory processes, tax incentives and more efficient clinical networks.
The numbers behind America’s anxiety are striking. Federal officials say China now runs more clinical drug trials than the US, and by one estimate, it accounted for 39% of all global trials in 2024.
Those facts deserve attention. Early-stage trials are not just technical exercises; they are the front door of biomedical innovation. Where they take place shapes which patients gain early access to new therapies, which institutions build expertise, where investment flows and whose regulatory standards become the global norm.
Still, the right question is not whether America can “beat” China. It is whether the US can make its system fast enough to attract science, rigorous enough to protect patients, and open enough to produce evidence the world can trust.
The proposed reforms point in that direction. The FDA plans to give companies earlier clarity on manufacturing requirements, dose selection and approval pathways and to review some applications on a rolling basis before all documents are complete.
The agency has also reaffirmed that, in certain cases, a single high-quality late-stage trial backed by confirmatory evidence can support approval, instead of the two trials long expected.
Other agencies are moving as well. The National Institutes of Health is expected to explore new trial designs, artificial intelligence and real-world data, along with faster ethics review. Federal health-technology officials are examining how electronic health records could connect more patients to studies.
These are sensible steps. The American system is not slow because regulators dislike innovation.
It is slow because so many separate stages — trial activation, contracting, ethics review, site selection, patient recruitment, data collection and communication between sponsors and regulators — operate as disconnected layers. Each may be defensible on its own. Together, they create the friction that pushes companies abroad.
The danger is that speed becomes a slogan. If faster trials simply mean thinner evidence, weaker oversight or more pressure on patients to enroll quickly, the US will not strengthen its position. It will effectively trade one disadvantage for another. Public trust, once lost, is far harder to rebuild than a regulatory timeline.
This is where the comparison with China should be handled with care. China’s rise in clinical research is not only a story of subsidies and light regulation. It reflects deliberate investment: dense hospital networks, large patient pools, growing scientific talent and tight alignment between industrial and health policy.
The US should study these strengths honestly, without caricature. Learning from a competitor is not surrender; it is strategic maturity.
At the same time, America’s real advantage was never so much speed as credibility. FDA decisions carry global weight because the agency is seen, for all its flaws, as methodologically serious and relatively transparent. So the US should compete not by imitating another country’s model, but by making trust itself the foundation of how it innovates.
One way to do that would be to build a national network of “trial-ready” sites. Instead of treating every study as a one-off project, the government could certify standing research networks that already have master contracts, agreed-upon data standards, privacy safeguards, community engagement plans and shared ethics review. Sponsors could plug into them quickly, and patients and doctors could see which sites meet clear quality benchmarks.
A second reform would make taking part in a trial less dependent on geography. If patients must travel repeatedly to specialized centers, enrollment will stay slow and unequal. A more practical future is one in which more research happens during routine care, supported by electronic health records and stronger local networks. That would make trials feel less like rare events and more like a normal part of health care.
It also helps to separate two kinds of speed. Regulatory speed means shorter queues and clearer instructions. Evidence speed means learning faster — through smarter trial designs, better measures of success, data that moves easily between systems, and tools that detect benefits and harms earlier. The first mainly helps companies; the second helps patients. A durable reform agenda needs both.
For Asia, the stakes go well beyond a two-way contest. If the US pulls more trials back home, research centers across the region could face stiffer competition for investment. But a better outcome is possible: clinical research that is more distributed and interoperable across trusted jurisdictions.
Rather than splitting into rival blocs, regulators could compete on quality while cooperating on the essentials — data integrity, patient protection and transparency.
That would serve China, the US and the wider region alike. China has an interest in the world trusting its research. The US has an interest in learning from efficient trial systems abroad. And patients everywhere have an interest in faster access to medicines that are genuinely proven, not merely promoted.
By that logic, a new FDA initiative should be judged against three tests. Does it cut needless bureaucracy without lowering the bar for evidence? Does it widen access to trials beyond elite academic centers and big-city hospitals? And does it produce evidence that other countries can examine, reproduce and trust?
If the answers are yes, the US will do more than win back trial volume. It will redefine what leadership in biomedical innovation actually means. In an age of strategic competition, the smartest country will not be the one that turns science into another battlefield. It will be the one that shows speed and trust can advance together.
Y. Tony Yang is an endowed professor at the George Washington University in Washington, D.C.
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