This new FOA supports applications to develop and implement phase II and beyond investigator-initiated single-site clinical trials. NHLBI seeks applications that propose to contribute to the evidence base for important health matters of relevance to the research mission of 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. In addition to scientific relevance and excellence, these clinical trials are expected to be conducted with a high degree of efficiency, with streamlined administrative procedures wherever possible.
This FOA is applicable to single site clinical trials that are phase II and above. For the purposes of this FOA, the definition of a single site clinical trial is one in which the protocol is implemented by one investigational site that conducts and coordinates the protocol. While a single site clinical trial may enroll participants from multiple locations/clinics within a geographic area, those participants will receive an intervention or undergo outcome assessments under the direction and oversight of one research team at one investigational site.
Proposed clinical trials may utilize a design anywhere along the continuum between explanatory and pragmatic. For this FOA, pragmatic trials are considered those that test an intervention under the usual clinical conditions in which it will be applied, while explanatory trials do so under more idealized circumstances. The trial design should be appropriate for the study question.
This FOA is intended to support Phase II or above single site clinical trials. This FOA will utilize a bi-phasic, milestone-driven R61/R33 mechanism consisting of a start-up phase (R61) and a full enrollment and clinical trial execution phase (R33). Applicants must address objectives for both a R61 and a R33 phase and are strongly encouraged to use project management principles as appropriate.
Phases of Award
The R61 phase will support finalization of the protocol and the informed consent/assent document; the development of the manual of operations, case report forms and other resources necessary to the performance of the protocol; further development of study partnerships; establishment of a Data and Safety Monitoring Board and review of the protocol; and Institutional Review Board approval of the trial. All necessary regulatory approvals, as well as source(s) of the necessary drugs, devices or other resources as needed, should be obtained to allow for the successful launch of the proposed clinical trial in the R61 phase. Enrollment into the clinical trial will begin in the R61 phase to allow for an evaluation by the end of the R61 phase of early enrollment and the probability of successfully completing the trial on time and on budget. An administrative review of the extent to which peer-reviewed milestones (including enrollment milestones) are met in the R61 phase will determine whether the R33 phase award will be issued, subject to NHLBI funding availability.
Delineation of milestones by the applicant for the R61 and R33 phases is a key characteristic of this FOA. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. This FOA will support applications that propose a series of milestones including expected enrollment goals in the R61 and R33 phases and for accomplishing the completion of the clinical trial on-time and on-budget. Applications that address contingency plans to proactively confront potential delays or disturbances in meeting the milestones are strongly encouraged. Satisfactory completion of R61 milestones will be assessed administratively by NHLBI to determine eligibility to transition to the R33 phase.
NHLBI policies regarding milestones and relevant clinical research/studies policies are described in NHLBI Accrual of Human Subjects (Milestones) Policy, NHLBI Policy for Inclusion of Women and Minorities in Clinical Research, and NHLBI Policy for Data and Safety Monitoring of Extramural Clinical Studies.
Clinical Trials Not Supported by this FOA
The following types of clinical trials are not intended to be supported by this FOA:
- Phase I (first-in-human) trials
- Observational studies that do not meet the NIH definition of a clinical trial
- Multi-site trials
- Drug or device safety trials
Specific Areas of Research Interest
Prior to submitting applications to this FOA, applicants are strongly encouraged to consult with the Scientific/Research contacts for the area of science for which they are planning to develop an application. Early contact (at least 12 weeks prior to submission) is encouraged. This period of time provides an opportunity for NHLBI staff to discuss the scope and goals, and to provide information and guidance to the applicants.
Deadlines: letters of intent are due 30 days before the corresponding deadlines, i.e., November 10, 2016; February 14, 2017; June 14, 2017; October 11, 2017; February 13, 2018; June 14, 2018; October 11, 2018; February 13, 2019; June 14, 2019
Filed Under: Funding Opportunities