This Notice is to announce the NHLBI policy regarding the submission of applications that seek to conduct a clinical trial (see the NIH definition of a clinical trial) within the mission of NHLBI. The types of clinical trials addressed in this Notice fall into the following categories: 1) pilot studies, 2) mechanistic clinical trials, 3) phase I (early phase) clinical trials, and 4) phase II and beyond clinical trials. Investigators are strongly advised to contact NHLBI scientific staff prior to submitting an application for a clinical trial to determine which Funding Opportunity Announcement (FOA) will best support the proposed clinical trial research and to obtain other important advice. 

Read full policy here.