The US Department of Health and Human Services (HHS) has announced a coordinated department-wide effort to strengthen America’s leadership in clinical trials.
Dubbed Operation Trailblazer, the plan also seeks to accelerate the development of lifesaving treatments and ensure that patients have access to the most innovative therapies in the world.
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This guidance would help shorten the timelines for Phase I trials, with the US Food and Drug Administration (FDA) also seeking to clarify regulatory expectations for sponsors that could reduce early trial timelines by six to 12 months.
The FDA has also issued draft guidance clarifying that, in many cases, one high-quality late-stage clinical trial with confirmatory evidence will generally be sufficient to provide substantial evidence of effectiveness in support of a drug approval.
Each of the HHS agencies will contribute to the strategy. The National Institutes of Health (NIH) is strengthening support for informative, well-powered clinical trials while advancing the responsible use of artificial intelligence, human cell-based models, real-world data (RWD), and practical clinical trial tools that can help move promising therapies to patients more efficiently without compromising scientific rigour.
NIH’s National Center for Advancing Translational Sciences (NCATS) is building on lessons learned from pioneering work that led to the first fully personalised CRISPR-based gene-editing treatment, helping accelerate the development of future therapies for patients with rare diseases.
NIH’s National Cancer Institute (NCI) is working with cancer centres, researchers, and other stakeholders to streamline clinical trial activation and improve enrolment in cancer studies that have contributed to major advances in patient care.
The Office of the National Coordinator for Health Information Technology (ONC) is exploring ways to better connect patients with clinical trials through electronic health records, helping eligible individuals learn about research opportunities as part of routine care.
Meanwhile, the Advanced Research Projects Agency for Health (ARPA-H) has launched major initiatives to modernise clinical research. Programmes such as Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE) and Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) are developing new approaches to test multiple treatments and diseases simultaneously and leverage AI and machine learning to predict safety, optimise dosing, and improve trial efficiency before patient enrolment begins.
The US government hopes these efforts will reduce unnecessary delays, increase participation in clinical research and strengthen domestic research capacity in the US.
Overseas hubs becoming more attractive
In recent years, a growing share of early-stage clinical research has moved overseas, threatening America’s position as the global leader in biomedical innovation.
China has become a dominant player in the clinical trial landscape, Peter Barschdorff, vice president and head of Deallus, a GlobalData company, said last month.
Data presented at Outsourcing in Clinical Trials (OCT) East Coast shows that in the US, the percentage of trials initiated has dropped from 49% in 2015 to 33% in 2025. Meanwhile, China has seen a significant rise, from 4% in 2015 to 30% in 2025.
This push is translating into results for China, with data showing it takes seven months on average for Phase I trials compared to 17 or more in the US. In addition, Phase I trial costs in China are 32% to 52% lower than in the US.
“The speed is just unbelievable. Not only is China cheaper, but also faster, and can lead to the approval of the asset much earlier. Of course, there are some risks – not everything is as well-oiled a machine as US headquartered companies, but the numbers are quite complex and convincing,” Barschdorff said.
Speaking about Operation Trailblazer, HHS Secretary Robert F. Kennedy (RFK) Jr. said: “America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas. Under President Trump’s leadership, HHS is launching a coordinated department-wide effort to restore America’s leadership in clinical research, remove unnecessary barriers, and bring more clinical research and investment back to the US. America led the world in medical innovation before. We will lead again.”
