Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

This Funding Opportunity Announcement (FOA) supports applications for the Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required). These trials are designed to develop and implement clinical research at a single site, focusing on areas including efficacy, comparative effectiveness, pragmatic and/or implementation research. Furthermore, these clinical trials may also explore various therapeutic, behavioral, and/or prevention strategies.

This announcement specifically applies to trials that align with the research mission of the National Heart, Lung, and Blood Institute (NHLBI) and meet the NIH's clinical trial definition (see NOT-OD-15-015). Applicants are recommended to familiarize themselves with the mission and research objectives of the NHLBI, found on their official website.

For the review process, this grant uses a two-phase, milestone-based award mechanism. The application should articulate the theoretical justification for the clinical trial and provide a thorough scientific and operational plan. It should outline project management, subject recruitment and retention strategies, performance milestones, scientific conduct of the trial, and how results will be disseminated.

While this FOA encourages but does not require the use of multiple Project Directors or Principal Investigators (PD/PI), applicants that include a PD/PI specialized in biostatistics, clinical trial design, and coordination are strongly preferred.