Simpler Grants.gov #PAR-25-026

NIH Solicitation: Early Phase Clinical Trials for HLBS Disorders (NHLBI)

This opportunity from the National Institutes of Health (NIH), managed by the National Heart, Lung, and Blood Institute (NHLBI), seeks applications for early phase clinical trials targeting heart, lung, blood, and sleep (HLBS) disorders. - Government Buyer: - National Institutes of Health (NIH) - National Heart, Lung, and Blood Institute (NHLBI) - Products/Services Requested: - Investigator-initiated clinical trial services for diagnostic and therapeutic interventions for HLBS disorders - Includes support for preclinical activities, clinical trial start-up, implementation, and site training - Bi-phasic, milestone-driven award structure (Phase I: pre-trial activities such as stability studies, shipping studies, and site training) - OEMs and Vendors: - No specific OEMs or vendors are named; the solicitation is open to investigator-initiated research - Unique/Notable Requirements: - Open to a wide range of eligible applicants (educational institutions, businesses, government entities, nonprofits) - Focus on both adult and pediatric populations - Emphasis on milestone-driven progress and final stage preclinical activities - Place of Performance/Delivery: - National Institutes of Health (federal office)

Description

This funding opportunity supports investigator-initiated Phase I clinical trials for diagnostic and therapeutic interventions targeting heart, lung, blood, and sleep disorders in adults and children. It provides support for clinical trial start-up, implementation activities, and final stage preclinical activities necessary for trial implementation. The award uses a bi-phasic, milestone-driven mechanism where the first phase focuses on pre-trial activities such as stability, shipping studies, and site training. The proposed trial can be single or multisite and must be directly related to the therapeutic or diagnostic under investigation.

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