Investigator Initiated Multi-Site Clinical Trials (Collaborative R01)

The support of multi-site clinical trials is one strategy NHLBI uses to improve the understanding of the clinical mechanisms of disease and to improve prevention, diagnosis, and treatment. The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for submitting grant applications for investigator-initiated multi-site randomized controlled clinical trials. The trials may address any research question related to the mission and goals of the NHLBI and may test clinical or behavioral interventions. The FOA is appropriate for applications to conduct phase II and phase III randomized clinical trials where participants are recruited from multiple sites. Large-scale pragmatic trials (such as comparative effectiveness trials) as well as trials designed to test efficacy of an intervention are appropriate. The trials may randomize at the individual (patient) level or at a group level (e.g., randomization of clinics, schools, worksites, etc.). Clinical trials involving NHLBI mission-related rare diseases that require coordination across multiple clinical sites are also suitable for submission to this FOA. In any case, the trial should propose the most efficient study design to complete the specific aims. For additional information about the mission, strategic plan, and research interests of the NHLBI, applicants are encouraged to consult the NHLBI website (http://www.nhlbi.nih.gov/about/strategicplan/index.htmThis Funding Opportunity Announcement is not intended for support of single-center studies or multicenter observational studies that are not testing an intervention. Clinical Coordination Center (CCC) and Data Coordination Center (DCC) applications are required to be submitted together when the proposed costs of the clinical trial exceed $500,000 (minus F&A for subcontracts) in any given year.