On Monday, June 22, 2026, the U.S. Department of Health and Human Services (“HHS”) announced Operation TrialBlazer, a coordinated department-wide initiative aimed at promoting clinical research leadership and engagement in the United States. The initiative emphasizes the growth of early-stage clinical research overseas, with HHS acknowledging the threat to “America’s position as a global leader.” See Operation TrialBlazer, HHS Roadmap to Maintaining U.S. Leadership in Early Clinical Research and Development, Executive Summary p. 2-3.

HHS indicated that Operation TrialBlazer will achieve the following six aims in supporting its mission:

  • Modernize regulatory requirements and processes;
  • Improve transparency for regulated entities;
  • Encourage the adoption of more efficient practices;
  • Ensure federal dollars are spent on adequately powered and designed trials;
  • Better utilize existing data sources and technologies for regulatory and data-generation purposes; and
  • Improve patient and participant access to and engagement in clinical trials, and remove disincentives that prevent health care workers from participating in research.

Id. at p. 2-3 and 20.

The initiative is focused on coordinated action across HHS operational divisions to support end-to-end clinical research efficiency and attract greater investment in U.S.-based clinical research by reducing operational barriers, accelerating drug development and increasing subject participation in clinical trials.

As part of this coordinated effort, HHS divisional investments include:

The U.S. Food and Drug Administration (“FDA”): FDA will implement various efforts that focus on (1) shortening the time to first-in-human clinical trials, focusing on investigational new drug (“IND”) application regulatory requirements and reimagining the pre-IND process, and (2) shortening later-stage clinical development, reducing administrative burden through institutional review board reform and increasing trial access and participation. Id. at p. 7. As part of this effort, FDA is soliciting industry comments on a proposed pilot program designed to shorten the time from drug identification to first-in-human drug trials. Expedited Investigational New Drug Pilot Program RFI.

National Institutes of Health (“NIH”): NIH will focus on improving the speed of clinical trials and operational efficiencies, as well as reducing costs in clinical research. Id. at p. 16. It will advance the responsible use of artificial intelligence (“AI”), human cell-based models, real-world data and practical clinical tools through its efforts. See HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials.

Advanced Research Projects Agency for Health (“ARPA-H”): ARPA-H will continue its initiatives to reduce animal testing reliance, improve new toxicity prediction models and generate evidence supportive of more efficient early clinical development pathways, continuing to develop new approaches and leverage AI and machine learning. ARPA-H will also focus on reducing repeated developmental work across similar products and therapeutic platforms and increasing consistency, scalability and predictability of advanced therapy manufacturing and clinical evaluation. Id. at p. 18; see also HHS Launches Unprecedented Department-Wide Effort to Restore American Leadership in Clinical Trials.

Office of the National Coordinator for Health Information Technology (“ONC”): ONC will support efforts to increase clinical trial participation using advanced health information technology and exchange of health information, which may include integrating electronic health records technology with ClinicalTrials.gov. Id. at p. 19.

The Office of Inspector General (“OIG”): OIG published a Request for Information seeking input from the industry as to whether any modifications are needed to the federal Anti-Kickback statute regulatory safe harbors or federal civil monetary penalties beneficiary inducement prohibitions to promote subject participation in clinical trials. View Hall Render’s recent article for additional detail. See Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP.

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Special thanks to Summer Associate Nick Baker for his assistance with the preparation of this article.

Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.

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