As Early-Phase Trials Move Overseas, Experts Urge the U.S. to Act
On Jan. 23, 2026, the DCRI Think Tanks program brought together a broad group of experts to examine a pressing concern in U.S. biomedical research: early clinical development is moving overseas, and it may not return without decisive action.
Participants from academic institutions, federal agencies, congressional offices, clinical research organizations, biotechnology companies, and investment firms discussed the factors driving the shift away from the United States and toward countries such as China and Australia, and what it will take to reverse this trend.
The Strategic Stakes
Discussions emphasized that this is not simply a research efficiency issue. China has used state-directed policies to achieve dominance in industries such as rare-earth minerals and electric vehicles, and experts agreed that pharmaceuticals are now a deliberate target. Through initiatives like Made in China 2025, China is systematically building its domestic capacity across the drug development pipeline—from manufacturing to early-phase clinical research.
By making Phase 1 trials faster and less expensive to conduct, China attracts U.S. biotechnology companies to run their earliest studies there. This gives Chinese firms direct access to innovations they can then replicate and improve. Over time, this dependency erodes U.S. early-phase capabilities and, as attendees cautioned, could eventually affect American patients' access to new medicines.
Why Companies Are Going Elsewhere
The appeal of countries like China and Australia extends beyond cost—it’s also about speed. Australia’s Clinical Trial Notification (CTN) system allows trials to begin in fewer than 70 days after a final protocol is submitted, supported by streamlined ethics review, simplified contracting, substantial tax incentives, and a reputation for high-quality data. In the United States, similar trials might wait years to start.
Much of this delay stems from the current pre-IND process. Chemistry, Manufacturing, and Controls (CMC) requirements place significant upfront demands on Phase 1 sponsors, even though there is considerable uncertainty at this stage about a therapy’s effectiveness. Early FDA feedback that goes beyond basic trial safety adds to the burden. While U.S. companies work through these requirements, competitors abroad often generate human safety, dosing, and early efficacy data sooner.
The Quality Question
Moving early-phase trials overseas is not without risk. Attendees noted that structural differences in healthcare organization and delivery—including government-directed care, varying standards for informed consent, and limited patient autonomy—can affect the quality and integrity of trial data. Adherence to Good Clinical Practice (GCP) standards is difficult to verify at sites with limited U.S. oversight, and data submitted to the FDA from foreign early-phase studies may not always meet the rigor of domestic trials. Experts agreed that stronger verification and enforcement mechanisms are essential.
Progress, and the Room Left to Make It
There is some momentum within the United States. Recent reforms have clarified the evidence standards for Phase 1 trials and reduced CMC requirements by improving platform designations. Attendees viewed these as meaningful steps, but also noted that the United States still lacks a coherent, nationally coordinated early-phase strategy that countries like Australia have established and that China is aggressively developing.
Experts emphasized that the path forward requires action on multiple fronts: streamlining regulation, standardizing site operations, creating financial incentives for domestic early-phase investment, and framing the entire effort as a national priority—not just a research policy issue.
Next Steps
The group identified several concrete steps to strengthen U.S. early-phase clinical development.
First and foremost, attendees called for the United States to establish clear national goals for Phase 1 leadership and to align regulatory, industry, and funding priorities. Financial mechanisms such as tax credits, rebates, or government-backed purchasing should be considered to incentivize domestic investment, especially in high-priority areas like cancer and chronic disease. Broader policy tools, including intellectual property reform, should also be explored.
Regulatory reform was seen as equally critical. Attendees recommended adapting aspects of Australia’s CTN framework, such as fit-for-purpose regulatory submissions and streamlined ethics review, while upholding patient safety and GCP standards. Phase-adapted IND requirements—with proportionate CMC standards for early-phase studies and clearer guidelines to reduce redundancy in Institutional Review Board review—should be established.
Streamlining day-to-day operations at U.S. sites is just as important as policy reform. Common templates for budgeting and contracting, public reporting of key trial metrics like time to startup, and a safe harbor for early-phase research would all reduce friction for sponsors considering domestic options. Investment in a more automated translational science ecosystem would further accelerate preclinical studies.
Finally, the integrity of data generated outside the United States must be addressed directly. Attendees called for authorized inspections or pre-certification processes for sites in countries of concern, stronger data quality requirements for foreign early-phase data submitted to the FDA, and proactive use of IND enforcement to signal regulatory rigor to sponsors.