HHS launches Operation TrialBlazer to advance US clinical research leadership

On June 22, 2026, the US Department of Health and Human Services (HHS) announced the launch of Operation TrialBlazer, a department-wide effort to restore US leadership in clinical research and innovation and encourage the return of clinical research and investment to the country.

Growing dominance of China in the clinical trial space

Although the United States has historically dominated the earliest stages of biomedical innovation, in recent years, early stage clinical research has increasingly moved overseas in order to avoid the long delays and administrative burdens US regulation imposes on clinical trial approvals and practices.

Through systematic expansion of its clinical research infrastructure with government backing, streamlined regulatory pathways, and sustained investment over the past two decades, China has made biotechnology a strategic national priority and now stands as a major US competitor. Indeed, China surpassed the United States in global shares of Phase 1 trials as early as 2021 and, in 2024, surpassed the United States in total number of registered clinical trials. Thanks to 2015 and 2025 reforms reducing approval backlogs and increasing public investments in biomedicine, China’s early discovery-to-investigational new drug (IND) cycles are now 50% to 70% faster than the rest of the world. China also utilizes investigator-initiated trials for cell and gene therapy, radioligand therapy, stem-cell therapy, and other cutting-edge modalities to provide even greater flexibility in clinical trial structure, albeit with certain tradeoffs in oversight and quality control. Comparatively, such studies in the United States might take years to commence. With respect to the effective date of IND applications, sponsors can expect a similar waiting period of approximately 30 days between both countries. In the United States, however, institutional review board (IRB) approval, contract negotiations, and other requirements can tack on an additional 13 months of delay before a single patient is enrolled. IND applicants in China, meanwhile, are not only permitted but are required to initiate their trial within 12 weeks of submission.

In the United States, delays are primarily concentrated in the pre-IND stage of development. Sponsors are forced to wait up to 60 days for a pre-IND meeting with the Food & Drug Administration (FDA) and often waste valuable time gathering unnecessary data due to misunderstanding of upfront chemistry, manufacturing, and controls (CMC) requirements and pharmacology/toxicology testing while their foreign counterparts are already generating human data that can attract investment. Even after the IND is approved, barriers to trial activation create further delays, especially those related to budget and contract negotiations, recruitment and retention, physician engagement, and restrictive enrollment criteria. On the patient side, the significant financial burden of participating in trials that often lack adequate compensation – or any compensation at all – makes involvement in clinical trials impractical for many would-be participants.

As a result of these hurdles, US investors are increasingly choosing to put their money towards Chinese research or US research in Chinese patients rather than investing in US-based research. In the long term, these immediate investments help Chinese companies develop intellectual property (IP), clinical track records, and first-in-human data that ultimately attract the kind of long-term investments that are sought domestically. As it currently stands, drugs developed by Chinese companies are projected to account for 35% of FDA approvals by 2040.

Goals of Operation TrialBlazer

The HHS seeks to reverse this trend through its Operation TrialBlazer initiative, which outlines a roadmap for modernizing and accelerating all stages of medical product development, with particular attention paid to early stage research. The initiative puts forth six overarching goals:

1. Modernize regulatory requirements and processes
2. Improve transparency for regulated entities
3. Encourage the adoption of more-efficient practices
4. Ensure federal dollars are spent on adequately powered and designed trials
5. Better utilize existing data sources and technologies for regulatory and data-generation purposes
6. Improve patient and participant access and engagement in clinical trials and removing disincentives preventing healthcare workers from being involved in the conduct of research.

The initiative then goes on to lay out how individual agencies intend to accomplish these goals, covering the FDA, National Institutes of Health (NIH), Advanced Research Projects Agency for Health (ARPA-H), and Office of the National Coordinator for Health Information Technology (ONC).

The FDA focuses on two strategic priorities: accelerating the time to first-in-human clinical trials by addressing the regulatory requirements for IND applications, and reimagining the pre-IND phase; and accelerating later-stage clinical development and reducing administrative burdens by pursuing significant IRB reform and increasing trial access and participation. The NIH puts forth initiatives focused on improving trial speed and operational efficiency through the use of artificial intelligence, human cell-based models, real-world data, and practical clinical trial tools, while reducing costs and maintaining scientific rigor. ARPA-H is advancing several programs intended to reduce major scientific and operational bottlenecks in early stage drug development, including Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST), which supports the development of predictive human and computational models designed to improve the ability to evaluate drug safety and efficacy before human testing begins, and Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE), which is designed to optimize affordability, scalability, and sustainability of lifesaving precision genetic medicines (PGMs) for patients through existing regional treatment centers and virtual clinics. ONC seeks to use electronic health records to better connect patients with clinical trials and help eligible individuals learn about research opportunities as part of their routine care.