NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required)

The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite. Applications submitted to this FOA must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website: http://www.nhlbi.nih.gov. This FOA will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training. It is anticipated that applications will present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes the plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to form a team with expertise in biostatistics, clinical trial design, and coordination as well as product manufacturing and formulation as appropriate. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application due to the complex nature of conducting a clinical trial. Staff will be able to assist applicants in meeting the objectives of this FOA.