Simpler Grants.gov #PAR-25-025

NHLBI Early Phase Clinical Trials for HLBS Disorders (R33 CT Required)

This opportunity invites applications for early-phase clinical trials focused on therapeutics and diagnostics for heart, lung, blood, and sleep (HLBS) disorders, managed by the National Heart, Lung, and Blood Institute (NHLBI) at the NIH. - Government Buyer: - National Institutes of Health (NIH) - National Heart, Lung, and Blood Institute (NHLBI) - Products/Services Requested: - Investigator-initiated phase I clinical trials for HLBS disorders in adults and children - Trials may be single or multisite - Applicants must be ready to initiate the trial within the first quarter of the project period - All regulatory approvals (FDA, DSMB, IRB), drug and placebo supplies, and third-party agreements must be secured by award time - Unique/Notable Requirements: - No specific OEMs or vendors are named; this is a grant for clinical research, not a product procurement - Open to higher education institutions, government entities, nonprofits, and businesses - Minimum award amount is $1,515,000 - Focus is on supporting clinical research, not acquisition of specific products or equipment - Place of Performance: - National Institutes of Health (NIH)

Description

This funding opportunity supports investigator-initiated phase I clinical trials for diagnostic and therapeutic interventions targeting heart, lung, blood, and sleep (HLBS) disorders in adults and children. Trials may be single or multisite, and applicants should be prepared to initiate the trial within the first quarter of the project period. Regulatory approvals and necessary supplies and agreements should be in place by the time of award. Applicants seeking support for pre-clinical or trial readiness activities should consider the companion R61/R33 phased approach NOFO.

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