Why Clinical Trials Are Leaving the US: Expert Q&A on FDA's Project TrialBlazer Limits
- FDA's Project TrialBlazer aims to cut IND review timelines by 6–12 months, but TruTechnologies' Richard Graham argues the initiative misses systemic bottlenecks driving trials to Australia and China.
- Phase 1 studies are migrating to Australia due to streamlined CTN processes and R&D tax credits; Phase 2–3 trials shift to China, where state-coordinated infrastructure and large treatment-naive patient pools accelerate enrollment and completion.
- Graham identifies fragmented stakeholder alignment—patients, sponsors, sites, CROs, investors, payers, regulators—as the core constraint; single-issue regulatory fixes cannot compete with China's top-down trial coordination model.
Operational Impact
CRO directors should expect continued Phase 1 volume loss to Australia and Phase 2–3 shifts to China despite TrialBlazer, signaling that US-based CRO capacity planning must account for structural competitive disadvantages beyond regulatory timelines.
Source: Pharmaceutical Executive RSS