Testimony: Advancing Innovation in Early-Stage Clinical Trials: Policy Options for Reauthorization of the User Fee Agreements

Early-stage clinical trial activity, particularly for cancer drugs, is increasingly shifting from the US to China even as the FDA remains the world’s leading regulator for novel drug approvals. To reverse this shift while preserving FDA’s evidentiary standards, recommendations ahead of upcoming user fee agreement reauthorization include raising global clinical trial standards, targeting fee and tax incentives toward small and academic sponsors conducting US trials, expanding transparency around clinical holds, and adding guardrails to FDA’s proposed Expedited IND Pilot Program.