HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials

WASHINGTON—JUNE 22, 2026—The U.S. Department of Health and Human Services (HHS) today announced a coordinated department-wide effort* “Operation TrialBlazer” to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.

For decades, randomized clinical trials have served as the gold standard for evaluating the safety and effectiveness of new medical treatments. Yet 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. Under President Trump’s leadership, HHS is taking decisive action to reverse that trend and make the United States the preferred destination for clinical research and medical discovery.

“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,” said HHS Secretary Robert F. Kennedy, Jr. “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 United States. America led the world in medical innovation before. We will lead again.”

As part of this effort:

• The Food and Drug Administration (FDA) is soliciting public comments on a proposal to develop a pilot program that would shorten the time it takes from drug identification to first-in-human Phase 1 clinical trials; additionally, FDA is clarifying regulatory expectations for sponsors that could reduce early trial timelines by six to 12 months. FDA has also issued draft guidance clarifying that, in many cases, one high-quality late-stage clinical trial with confirmatory evidence will generally be sufficient to provide substantial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.
• 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, and practical clinical trial tools that can help move promising therapies to patients more efficiently without compromising scientific rigor.
• NIH’s National Center for Advancing Translational Sciences (NCATS) is building on lessons learned from pioneering work that led to the first fully personalized 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 centers, researchers, and other stakeholders to streamline clinical trial activation and improve enrollment 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.
• The Advanced Research Projects Agency for Health (ARPA-H) has launched major initiatives to modernize clinical research. Programs 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, optimize dosing, and improve trial efficiency before patient enrollment begins.
• The HHS Office of Inspector General is publishing a Request for Information seeking input from the public on whether any additions or modifications are needed to safe harbor regulations under the Federal anti-kickback statute, or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries for remuneration provided to individuals in connection with their participation in clinical trials.

Together, these efforts are designed to reduce unnecessary delays, increase participation in clinical research, strengthen domestic research capacity, and help ensure that the next generation of medical breakthroughs is developed in the United States.

For this to be a success, the entire U.S. research enterprise will need to do its part to streamline their processes. HHS will continue working with industry, academic medical centers, contract research organizations, patient groups, health care providers, and other partners to identify barriers to clinical research and remove unnecessary obstacles that slow innovation.

The Department’s actions reflect a broader commitment to strengthening American scientific leadership, expanding patient access to cutting-edge treatments, and ensuring that the United States remains the world leader in medical innovation.

*This content is undergoing Section 508 remediation and will be updated once all standards are met. Therefore, individuals with disabilities may not be able to fully access information in this file. For assistance, contact ASPADigital@hhs.gov.