FDA introduces new pilot programme to accelerate early-stage clinical research

These actions are outlined in Operation TrialBlazer, a US Department of Health and Human Services initiative. As part of this initiative, the FDA has launched the voluntary Expedited Investigational New Drug (IND) Pilot Program. Under this programme, sponsors collaborate with scientific experts at qualified research institutions (QRIs) to reduce time from initiation of IND-enabling activities to first-in-human (FIH) study start. QRIs could include, but are not limited to, contract research organisations, academic research centres and health networks. These QRIs would provide the sponsor with expert advice on pharmacology, toxicology, clinical, and chemistry, manufacturing and controls components of the FIH IND submission. Sponsors and prospective QRIs will apply as a pair with the sponsor submitting the programme application. The FDA anticipates eight to ten sponsor-QRI pairs will be selected to participate in the initial pilot programme.

A key advantage of this programme is that the FDA would accept and review individual components of the IND submission on a rolling basis. This facilitates issues being flagged incrementally and resolved in a progressive manner, therefore reducing the risk of a clinical hold when the whole package is received. This in turn would mean the FIH study could begin earlier.

‘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, JD.

The deadline for sponsors to submit applications to the programme is 30 October 2026 (dependent on the number of applications received). The FDA will select successful applicants by 18 December 2026.

Further details of the programme can be found here.