The United States is losing ground in the global competition for clinical trials—and U.S. regulators are taking notice. On August 6, 2026, the FDA held an educational webinar on its proposed Expedited Investigational New Drug (IND) Pilot Program, a centerpiece of the Department of Health and Human Services’ broader Operation TrialBlazer initiative (FDA, Educational Webinar: Expedited IND Pilot Program, Aug. 6, 2026). For life sciences companies evaluating where to conduct early-phase research, the program merits close attention.

A Stark Competitive Reality

The data is striking. According to FDA, the United States has lost approximately 10% of its global share of Phase 1 clinical trials since 2015 (FDA Webinar). China surpassed the United States in Phase 1 trials for the first time in 2021, and by 2024 accounted for 39% of all global clinical trials registered (FDA Webinar). A study by the National Security Commission warned that if current trends are not reversed by 2028, the offshoring of clinical trials could become effectively irreversible (National Security Commission, Study on Clinical Trial Offshoring Trends). HHS has characterized the window for U.S. action as “measured in years, not decades” (HHS, Operation TrialBlazer Initiative, 2026).

What is driving sponsors to conduct trials abroad? In large part, speed. China’s Center for Drug Evaluation (CDE) now offers a 30-working-day fast-track review mechanism for eligible innovative drugs—a significant reduction from the 60-working-day timeline established just a few years prior (China CDE, 30-Working-Day Fast-Track Review Mechanism Proposal, 2025). Combined with treatment-naïve patient populations that can enable enrollment two to three times faster than U.S. sites, China has become an increasingly attractive option for first-in-human studies (FDA Webinar). Australia’s Clinical Trial Notification (CTN) scheme, administered by the Therapeutic Goods Administration, offers another expedited pathway: sponsors can begin dosing within five to six weeks, with no pre-trial regulatory review of study data and access to a 43.5% R&D tax rebate (TGA, Clinical Trial Notification Scheme). Importantly, data generated under either pathway can generally support subsequent FDA approval.

The FDA’s Answer: Qualified Research Institutions and Rolling Submissions

The pilot’s central innovation is a new partnership model. Sponsors would pair with Qualified Research Institutions (QRIs)—academic medical centers, contract research organizations, or regulatory advisors with demonstrated expertise across nonclinical, CMC, clinical, and regulatory disciplines (FDA Webinar). QRIs would provide written recommendations on each IND component before submission, functioning as expert partners in developing higher-quality applications. Importantly, QRIs would serve in an advisory capacity only; the FDA would retain sole authority over all regulatory decisions, including clinical holds (FDA Webinar).

The pilot also introduces rolling IND submissions—allowing sponsors to submit nonclinical data, CMC information, and clinical protocols sequentially and receive FDA feedback on each component before proceeding (FDA Webinar). This iterative approach, analogous to rolling review available for NDAs and BLAs under existing expedited programs but applied at the IND stage for the first time, creates earlier opportunities to identify and resolve deficiencies. The FDA has suggested that clarifying phase-appropriate requirements at this early stage could reduce development timelines by 6 to 12 months (FDA Webinar). The standard 30-day IND review period would remain in effect, but the agency anticipates that most substantive issues will be addressed through the rolling component review before that clock begins (FDA Webinar).

What’s at Stake

For emerging pharma and biotechnology companies whose financing milestones depend on reaching first-in-human dosing quickly, a faster domestic pathway could meaningfully reshape development strategy. The geopolitical dimension adds further complexity: Congressional efforts to restrict FDA acceptance of clinical data generated in China, combined with supply chain considerations under the BioSecure Act, may make a competitive U.S. option not merely attractive but strategically necessary for certain sponsors.

As HHS Secretary Kennedy observed, early-phase trials “influence where companies expand, where expertise develops and which countries will lead the next generation of medical innovation” (HHS, Operation TrialBlazer Initiative). The implications extend beyond trial counts to encompass the broader domestic research infrastructure—including academic medical centers, the clinical research workforce, and patient access to investigational therapies.

Next Steps

The FDA has solicited public input through a Request for Information (RFI), with comments due August 24, 2026 (FDA, Request for Information: Expedited IND Pilot Program). Companies considering participation should begin evaluating potential QRI partnerships. The pilot is voluntary—sponsors may continue to submit INDs through the existing process—but for those prepared to engage, it represents one of the FDA’s most significant structural initiatives in recent years to enhance U.S. competitiveness in early-stage clinical development.

For questions about the Expedited IND Pilot Program or its implications for your development programs, please contact Foley Hoag’s Life Sciences team.