The United States is right to be concerned about losing ground to China in clinical research. But if Washington frames trial reform primarily as a race, it risks missing out on the biggest prize: a faster, safer and more reliable model for drug development that the rest of the world can rely on.
Food and Drug Administration (FDA) news. pilot programpart of a broader effort by the Department of Health and Human Services, aims to accelerate early-stage trials and could cut development timelines by six to 12 months.
It responds to a real difference. More early drug research has moved overseas — in China, but also in 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 staggering. Federal officials say China now conducts more clinical drug trials than the US, and by one estimate, it would account for 39% of all global trials in 2024.
These facts deserve attention. Early stage trials are not just technical exercises; they are the front door to biomedical innovation. Where those forms occur that patients gain early access to new therapies, which institutions build expertise, where investments flow and whose regulatory standards become the global norm.
However, the right question is not whether America can “beat” China. It’s 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 this direction. The FDA plans to give companies earlier clarity on manufacturing requirements, dose selection and approval pathways, and review some applications iteratively before all paperwork is complete.
The agency has also reconfirmed that, in certain cases, a high quality single late-stage trial supported by confirmatory evidence could support approval, rather than the long-awaited two trials.
Other agencies are also moving. The National Institutes of Health is expected to explore new trial designsartificial intelligence and real-world data, along with faster ethics review. Federal health technology officials are exploring how electronic health records can connect more patients to studies.
These are sensible steps. The American system is not slow because regulators don’t like innovation.
It’s slow because so many separate phases—trial activation, contracting, ethics review, site selection, patient recruitment, data collection, and communication between sponsors and regulators—operate as disconnected layers. Each can be protected separately. Together, they create the friction that drives companies abroad.
The danger is that speed becomes a slogan. If faster trials simply mean thinner trials, 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 much more difficult to rebuild than a regulatory timeline.
Here the comparison with China should be treated with caution. China’s growth in clinical research is not just a story of easy subsidies and regulation. It reflects deliberate investment: dense hospital networks, large patient pools, growing scientific talent and close harmonization between industrial and health policy.
The United States 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 reliability. The FDA’s decisions carry global weight because the agency is seen, for all its flaws, as methodologically serious and relatively transparent. So the US must compete not by imitating another country’s model, but by making trust itself the foundation of how it innovates.
One way to do this would be to build a national network of “trial-ready” sites. Instead of treating each study as a single project, the government could certify existing research networks that already have major contracts, agreed data standards, privacy protections, community engagement plans, and joint ethics review. Sponsors could quickly enter them, and patients and doctors could see which sites met clear quality standards.
A second reform would make participation in a trial less dependent on geography. If patients must constantly travel to specialized centers, enrollment will remain slow and uneven. A more practical future is one in which more research takes place over time routine caresupported by electronic health records and stronger local networks. This would make the trials feel less like rare events and more like a normal part of health care.
It also helps to separate the two types of speed. Regulatory speed means shorter queues and clearer guidelines. Trial 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 sustainable reform agenda needs both.
For Asia, the stakes go beyond a two-way race. If the US pulls more evidence home, research centers across the region could face tougher competition for investment. But a better outcome is possible: clinical research that is more distributed and interoperable across trusted jurisdictions.
Instead of splitting into rival blocs, regulators can compete on quality while cooperating on the essentials—data integrity, patient protection, and transparency.
This would serve China, the US and the wider region. China has an interest in the world trusting its research. The United States has an interest in learning from efficient probation systems abroad. And patients everywhere are interested in faster access to drugs that are actually proven, not just promoted.
By this logic, a new FDA initiative must be judged against three tests. Does it cut unnecessary red tape without lowering the bar for evidence? Does it expand access to evidence beyond elite academic centers and big city hospitals? And does it produce evidence that other countries can examine, replicate and believe?
If the answers are yes, the U.S. will do more than recover the trial volume. It will redefine what leadership in biomedical innovation really means. In an era of strategic competition, the smartest country will not be the one that turns science into another battlefield. It will be one that shows that speed and confidence can go hand in hand.
Y. Tony Yang is an endowed professor at George Washington University in Washington, DC
