NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3) - Clinical Trial Required

The purpose of this Funding Opportunity Announcement (FOA) is to solicit UG3/UH3 phased cooperative agreement research applications to plan and implement clinical trials. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to a clinical trial implementation phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase will permit the Principal Investigator to finalize the study team and will support activities to develop: the final clinical protocol; the Clinical Investigators Brochure (or equivalent), if needed; the data management system and other tools for data collection and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents such as the Manual of Procedures for the subsequent clinical trial in the UH3 phase. The UG3 planning phase is not designed for the collection of preliminary data on the efficacy of the intervention (such as pre-clinical studies with animals), or the collection of observational data from humans to support the rationale for a clinical trial. Evaluation of the potential subject population to determine individuals eligibility for participation in the future UH3 trial is allowed in the UG3 phase but not required. The UH3 phase of the award will support the conduct of one investigator-initiated clinical trial intended to assess safety and/or efficacy of various types of interventions.