HHS Launches Broad Initiative to Boost US Clinical Trial Research Amid Global Competition

The U.S. Department of Health and Human Services has launched a sweeping department-wide initiative aimed at accelerating clinical research and restoring American leadership in biomedical innovation. The effort includes new programs across the Food and Drug Administration, the National Institutes of Health, and other federal health agencies designed to shorten drug development timelines, expand domestic clinical trial activity, and increase patient access to experimental therapies.

The initiative comes as federal officials point to a growing shift of clinical research activity overseas. According to an HHS roadmap, China surpassed the United States in total registered clinical trials in 2024, accounting for more than 7,100 trials, or approximately 39% of global clinical studies. In 2021, China also exceeded the United States’ share of Phase 1 clinical trials for the first time.

At the center of the FDA's contribution is a proposed Expedited Investigational New Drug pilot program that would allow qualified academic medical centers, contract research organizations, and other institutions to work directly with sponsors in developing Phase 1 clinical trial protocols. The agency opened a public comment period on the proposal through July 22. The agency also issued draft guidance clarifying circumstances under which a single rigorous late-stage clinical trial, combined with confirmatory evidence, may provide sufficient evidence of effectiveness to support drug approval.

In a separate announcement, the FDA unveiled two major steps for implementing real-time clinical trials (RTCT). The agency successfully initiated two proof-of-concept clinical trials that will report endpoints and data signals in real time. It also released a Request for Information regarding a proposed pilot program for RTCT that will launch this summer, leveraging AI and data science to enhance safety monitoring and increase efficiency.

The National Institutes of Health is expanding efforts to support large clinical studies while increasing the use of artificial intelligence, real-world evidence, and advanced human cell-based research models. The Office of the National Coordinator for Health Information Technology is exploring ways to integrate clinical trial opportunities into electronic health record systems.

Meanwhile, the NIH's RECOVER-Treating Long COVID (RECOVER-TLC) initiative is set to begin enrolling participants in new clinical trials this summer, marking nearly two years after its launch. RECOVER-TLC started in September 2024 and plans to begin enrolling for two new trials: one testing low-dose naltrexone in children and young adults, and another testing the GLP-1 receptor agonist semaglutide. A third trial testing the immunomodulating drug baricitinib is already enrolling.

The original RECOVER program received $1.1 billion in initial funding from Congress in late 2020, with additional funds now totaling about $1.8 billion. RECOVER-TLC has selected four treatments for its initial round of trials from nearly 600 potential treatments submitted by researchers, patients, and community members.