FDA unveils framework for its expedited IND pilot

The FDA has published the design of its expedited Investigational New Drug (IND) pilot, part of a plan to restore US competitiveness in clinical research, and will now accept applications to take part from study sponsors.

The new initiative is designed to shorten the time it takes to transition from discovering a drug to starting first-in-human phase 1 clinical trials in the US, and is a key piece of the HHS's Operation Trailblazer, revealed in June, which aims to reduce red tape and speed up clinical trials and drug development in the US.

Trailblazer was launched in response to the emerging competitive threat from China, which has now overtaken the US in terms of the number of registered clinical trials.

The expedited IND programme will allow trial sponsors to partner with a set of qualified research institutions (QRIs) to review IND applications in rolling parts, rather than all at once, and aims to make "the path from scientific discovery to first-in-human trial faster, more predictable, and more collaborative," according to the FDA.

The pilot responds to concerns that navigating the IND process – which involves review of phase 1 trial protocols used to determine dosing, absorption, and initial safety in humans – can take up to two years in the US, but just a few months in China and other countries like Australia. The scheme aims to slash timelines in the US by six to 12 months.

The FDA will accept applications to participate in the pilot until 30th October, and intends to notify successful applicants by 18th December.

"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," said Acting FDA Commissioner Kyle Diamantas.

"Under the Trump Administration, boosting domestic innovation and ensuring American patients have first access to groundbreaking treatments is a top priority," he added. "The FDA will continue implementing Operation Trailblazer to modernise regulatory processes to keep our country ahead of global competitors without compromising patient safety."

The pilot will generate evidence to inform potential future approaches to modernising FDA's support for early-stage clinical development, according to the agency, which suggested it could lead to a formal accreditation model for QRIs and create a network of institutions to support drug development and accelerate the time to first-in-human trials.

Mwango Kashoki, who is head of regulatory science at contract research organisation Parexel, said the pilot could lead to a "meaningful shift" in the use of phase-appropriate data and greater flexibility in how evidence is structured.

"At its core, the programme will enable sponsors to generate more decision-relevant data earlier, improving clarity at the point of first-in-human evaluation," she said.

"Over time, this approach has the potential to streamline development pathways while maintaining a strong scientific foundation, ultimately supporting faster, more efficient translation from drug discovery to clinical testing."