Simpler Grants.gov #PAR-27-012

NIH Solicits Clinical Coordinating Center for Multi-Site Clinical Trials

The National Institutes of Health (NIH), through the Division of Cardiovascular Sciences, is seeking applications to establish a Clinical Coordinating Center (CCC) for multi-site investigator-initiated clinical trials: - Government Buyer: - National Institutes of Health (NIH), Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute (NHLBI) - Products/Services Requested: - Development and operation of a Clinical Coordinating Center (CCC) to manage multi-site clinical trials in cardiovascular, lung, blood, and sleep disorders - Responsibilities include project management, subject recruitment and retention, performance milestones, scientific conduct, and dissemination of results - Applicants must also submit a collaborating Data Coordinating Center (DCC) application - Unique or Notable Requirements: - Trials may use innovative designs such as platform, adaptive, and Bayesian methodologies - Milestone-driven cooperative agreements - Emphasis on community engagement strategies - Compliance with NIH policies regarding foreign subawards and collaborations (foreign subawards not permitted) - No specific OEMs or commercial vendors are named, as this is a service-based research opportunity

Description

This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. The application should present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan addressing project management, subject recruitment and retention, performance milestones, scientific conduct, and dissemination of results. Both a CCC application and a collaborating Data Coordinating Center (DCC) application must be submitted on the same due date for consideration by NHLBI.

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