FDA launches pilot program to speed up sluggish phase 1 trials

Biotech FDA launches pilot program to speed up sluggish phase 1 trials By Darren Incorvaia Sep 15, 2026 2:09pm Food and Drug Administration (FDA) Department of Health and Human Services (HHS) clinical trials IND After teasing a new initiative to speed up early-stage clinical trials over the summer, the FDA today opened a pilot program for an expedited investigational new drug (IND) application process that the agency hopes will put U.S. phase 1 trials on par with those in China and Australia. The finalized pilot program will pair drug sponsors with selected “qualified research institutions” or QRIs, which can include contract research organizations, academic medical centers, regulatory advisors and other related entities.

QRIs and sponsors accepted into the program will be paired up, with the intention of then submitting an IND on a faster, rolling basis. FDA staff will review applications and choose around eight or 10 pairs for the pilot, which is accepting submissions until Oct. 30.

“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 in an agency release. The program is part of what the FDA calls Operation Trial Blazer, announced in June, and is also set to include other efforts across the Department of Health and Human Services. The ultimate goal, Diamantas said at the time, was to reduce phase 1 trial timelines by six months to a year.

When choosing participants for the IND pilot, the agency will prioritize sponsors who have novel investigational products for diseases with severe unmet need and have already generated enough preclinical data for the FDA to judge their IND prospects. For QRIs, the FDA will choose proven leaders in an array of “core disciplines,” the agency said, including pharmacology and toxicology; chemistry, manufacturing, and controls; clinical safety monitoring and patient enrollment; clinical pharmacology; and regulatory affairs. “The FDA greatly appreciates the public feedback we received on the proposed pilot, and we have incorporated that feedback into the final pilot design,” Michael Davis, M.D., Ph.D., the newly minted head of the FDA’s Center for Drug Evaluation and Research, said in the release.

“The FDA is committed to ensuring the United States remains the global standard for pharmaceutical innovation and regulatory rigor for the benefit of American patients and innovators.” The pace of phase 1 trials in the U.S. has become an area of increasing concern, as other countries like Australia and especially China boast much speedier processes to bring promising new drugs into human testing. China’s pathway of investigator-initiated trials has come under scrutiny, however, due to numerous patient deaths that have recently been revealed but weren’t previously disclosed.

Food and Drug Administration (FDA) Department of Health and Human Services (HHS) clinical trials IND drug development CRO Biotech