WASHINGTON, D.C. — The U.S. Food and Drug Administration finalized an expedited regulatory pilot that will pair drug companies with qualified research institutions to shorten the path to first-in-human clinical trials, part of the Trump administration’s effort to accelerate domestic drug development while retaining FDA oversight.
The Expedited Investigational New Drug Pilot will allow the FDA to review individual components of an IND application on a rolling basis during the pre-IND phase rather than waiting for all components to be ready before beginning its review.
The agency said the approach is intended to identify and resolve problems earlier, reducing the risk that a first-in-human trial is placed on clinical hold during the 30-day IND review period.
Drug sponsors participating in the program will work with qualified research institutions, or QRIs, that have scientific expertise relevant to preparing IND applications. Sponsors and prospective QRIs must apply as pairs, with the drug company submitting the application to the FDA.
The FDA expects to select eight to 10 sponsor-QRI pairs for the initial cohort. Applications will be accepted through Oct. 30 and reviewed by FDA scientific experts.
The program is part of the Department of Health and Human Services’ Operation TrialBlazer and reflects an effort by federal regulators to reduce development timelines for early-stage clinical research in the U.S. The FDA said first-in-human trials can take up to two years to complete domestically and cited faster timelines in China and Australia as a competitive concern.
“The pilot not only pairs industry innovators with top research institutions to accelerate high-quality data being submitted to the FDA, it also tests if the partnership can accelerate what happens after the FDA allows a clinical trial to proceed,” Acting FDA Commissioner Kyle Diamantas said.
First-in-human trials are used to establish factors including appropriate dosing and how an investigational drug is absorbed before later stages of clinical development.
The pilot will also encourage earlier coordination of activities that can occur alongside IND development, including Institutional Review Board review and clinical trial site activation. The agency’s aim is to reduce delays between preparation of an IND submission and the start of human testing.
The FDA will retain full regulatory authority over participating applications, including decisions on whether a clinical investigation can proceed or should be placed on hold.
Karim Mikhail, director of the FDA’s Center for Biologics Evaluation and Research, said the agency hopes the program can use the U.S. research system to accelerate the transition to first-in-human trials.
“The FDA is doing our part to ensure American patients continue to receive access to therapies first, while keeping scientific innovation and investment in America,” Mikhail said.
Results from the pilot could also inform future changes to the FDA’s approach to early-stage drug development. The agency said one possibility is a formal accreditation model for research institutions that demonstrate sufficient scientific and regulatory judgment to assist sponsors with drug development.
The final pilot design incorporates public feedback received on the agency’s earlier proposal, according to Michael Davis, director of the FDA’s Center for Drug Evaluation and Research.
The FDA said eligibility requirements, conflict-of-interest provisions and selection criteria are available on its Expedited IND Pilot webpage at https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development/fda-expedited-investigational-new-drug-ind-pilot-program.
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