The United States needs to maintain its leadership in clinical research and medical innovation. Recent studies indicate we are actually losing our edge. For instance, China has taken the lead in early-stage clinical trials, and as of 2025, companies from China were involved in nearly half of the global pharmaceutical licensing activities. This should raise alarms for Americans across the board.
Clinical trials have been pivotal in advancing medicine for nearly 80 years. They are essential for turning scientific breakthroughs into treatments that can save lives. By testing new therapies for safety and efficacy, these trials produce the evidence necessary for doctors, patients, and regulatory bodies to make informed choices.
However, clinical trials do more than just generate data; they attract investment and scientific talent, fostering a supportive environment for innovation. When clinical research relocates abroad, this vital infrastructure often follows suit.
Early-stage trials play a crucial role in determining where new technologies will be tested and perfected. They affect company expansion, the development of expertise, and which countries will lead future medical advancements.
The U.S. cannot afford to cede this vital advantage. Clinical research not only creates skilled jobs but also accelerates patient access to new treatments. It is foundational for economic growth, public health, and national security. The barriers we face in maintaining clinical research should be removed.
Under President Trump’s administration, the Department of Health and Human Services is already taking steps. Agencies like the FDA, NIH, and CMS have joined forces to enhance the U.S. clinical research landscape and incentivize more investment domestically.
For instance, the FDA, with Acting Commissioner Kyle Diamantas at the helm, is developing a pilot program aimed at clarifying expectations for sponsors and speeding up Phase 1 development. The agency believes these changes could trim development timelines by 6 to 12 months. Importantly, they’ve clarified that a single, high-quality clinical trial, supplemented by confirmatory evidence, can suffice for approval in many situations.
At NIH, Director Jay Bhattacharyya is amplifying support for impactful clinical trials while also advancing tools like artificial intelligence and real-world data. These innovations could help deliver promising treatments more efficiently. NIH is also learning from groundbreaking gene-editing therapies to enhance cancer clinical trials and boost enrollment.
The Office of the National Coordinator is endeavoring to connect more eligible patients to trials through electronic health records and other digital resources integrated into everyday practice.
At ARPA-H, technology is being developed to spot promising treatments, predict safety problems early, refine trial designs, and lower development costs.
The Health Department’s Office of Inspector General is currently asking for public input on whether existing regulations unnecessarily hinder compensating clinical trial participants while ensuring safeguards against fraud.
The underlying aim of these initiatives is straightforward: to establish the U.S. as the premier location for clinical research and drug development.
But achieving this result requires collaboration beyond government. Researchers, health systems, academic institutions, tech firms, and drug developers all play crucial roles. If you feel that regulations or institutional practices are impeding research, we want to hear from you. We’re ready to reevaluate assumptions and eliminate barriers that don’t benefit patients or the broader public good.
At the same time, we must hold fast to key principles. Patients deserve transparency and informed consent, as well as assurance that medical choices are backed by solid scientific evidence. Speeding up clinical research should not compromise our scientific and ethical standards.
HHS is committed to restoring America’s status in clinical research under President Trump’s leadership. We’re modernizing processes that currently stifle innovation and laying a foundation for the next wave of medical breakthroughs.
Innovation will remain our focus. We will continue to lead the field.
