Snapshot

The Operation Trailblazer pathway has been developed by the of United States.

This pathway can be used where Operation TrialBlazer aims to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world. .

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Target time assessment is The pilot will establish a network of Qualified Research Institutions (“QRIs”), including academic medical centers, healthcare networks, contract research organizations, and regulatory advisors, who will partner with sponsors to develop and review IND submissions for first-in-human clinical trials. Sponsors will retain full ownership of their IND, and the QRI network will serve as a review and advisory resource, specifically assessing their pharmacology/toxicology, clinical, and CMC components of the submission. Concurrently, the FDA will establish a new real time rolling submission platform that would allow the FDA to review QRI recommendations and components of the IND submission on a rolling basis and communicate securely with the sponsor to provide timely guidance. Similar to the rolling review of an NDA or BLA under FDA’s expedited review programs, this approach would allow individual IND components to be reviewed prior to formal IND submission. This model allows for a collaborative, iterative approach to the Pre-IND process, and allows FDA reviews to focus their attention where it is most needed while accelerating the sponsor’s path to IND readiness. FDA will retain full regulatory authority and decision-making on the INDs. The pilot will also be used to explore creative ways to address the delays that occur after an IND is granted, from IRB approval to site contracting and patient enrollment, which has become a rate-limiting step in the efficiency of U.S. clinical trial initiation..