Simpler Grants.gov #PAR-27-013

NIH Seeks Data Coordinating Center for Multi-Site Clinical Trials (Collaborative U24 Clinical Trial Required)

The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), is seeking a Data Coordinating Center (DCC) to support multi-site clinical trials: - Government Buyer: - National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) - Products/Services Requested: - Data Coordinating Center services for investigator-initiated multi-site clinical trials - Project coordination, administration, data management, and biostatistical support - Collaboration with a Clinical Coordinating Center (CCC) is required - Notable Requirements: - Applicants must submit both DCC and CCC applications - Innovative trial designs encouraged (platform, adaptive, Bayesian, etc.) - Trials may test therapeutic, behavioral, or prevention strategies - Eligible applicants include nonprofits, educational institutions, government entities, and businesses - Restrictions on foreign subawards/subcontracts - Funding instrument is a cooperative agreement (grant) - No specific OEMs or vendors are mentioned, as this is a grant for research coordination services, not product procurement

Description

This Notice of Funding Opportunity (NOFO) supports applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). The application should describe its approaches to collaborate with the Clinical Coordinating Center on implementation of the community engagement plan. Both a DCC application and a collaborating CCC application must be submitted on the same due date.

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