Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes - Data Coordinating Center (Collaborative U24 Trial Required)

This NOFO will support applications to develop and implement a Data Coordinating Center (DCC) for a multi-site clinical trial among young adults without clinical atherosclerotic cardiovascular disease (ASCVD). It will utilize a milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO that encourages applications for a collaborating Clinical Coordinating Center (RFA-HL-25-010). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. The application should also describe its approaches to collaborate with the CCC (RFA-HL-25-010) on implementation of the clinical trial community engagement and diversity plans, as well as reducing health inequities. Clinical trials using innovative designs such as platform trials, adaptive, and Bayesian designs are welcomed. Applications for both a DCC and a Clinical Coordinating Center (CCC) must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).