The US Food and Drug Administration (FDA) is set to launch its expedited investigational new drug (IND) pilot as it targets matching Australia and China in Phase I trials.
This pilot scheme comes as part of Operation Trialblazer, a scheme in which the US is trying to reduce its current two-year Phase I trial timeline to something more similar to that seen in China and Australia.
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Analysis conducted by Deallus, a GlobalData company, found that on average, Phase I trials in China took an average of seven months compared with 17 months in the US. GlobalData is the parent company of Clinical Trials Arena.
Driven by President Trump’s directive, the IND pilot seeks to accelerate the time it takes from identifying a drug to initiating a first-in-human (FIH) trial by partnering drug companies with qualified research institutions (QRI) that have scientific expertise to support efficient development of IND applications.
The pilot will help test whether a rolling review during the pre-IND phase allows issues with an IND application to be identified and resolved sooner, reducing the risk of the FDA placing the trial on a protocol hold. It will also consider the coordination of activities that occur alongside IND review, including Institutional Review Board review and clinical trial site activation.
Karim Mikhail, director of the Center for Biologics Evaluation and Research (CBER), said: “The pilot hopes to utilise the American innovation ecosystem to accelerate the time to first-in-human clinical 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.”
The FDA will accept applications to participate in the pilot until 30 October 2026, with an estimated eight to 10 sponsor and QRI pairs to participate.
Trialblazer hopes to put US back on early-stage map
Operation Trialblazer includes other initiatives to improve both the quality and speed of Phase I research in the US, such as ensuring the production of high-quality data and interoperability and modernisation of research, such as the integration of artificial intelligence (AI).
Experts who spoke to Clinical Trials Arena all cited the expedited IND pathway as the most beneficial part of Operation Trialblazer. They agreed, however, that both China and Australia still remain attractive regions for early-stage research due to the lack of an IND equivalent required in Australia, as well as tax credits and the cost benefits of running Phase I trials in China, which also has a large patient population.
