This notice of funding opportunity (NOFO) encourages applications for investigator-initiated multisite clinical trials (e.g., efficacy, effectiveness, or pragmatic trials) to study the effects of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions), and/or multicomponent interventions that include physical, psychological, and/or nutritional approaches in NCCIH-designated areas of high research priority. Clinical coordinating centers (CCC) should develop and implement the proposed fully powered multisite clinical trial (Phase III and beyond). The objective of a CCC application is to present the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. CCC applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. CCC applications submitted under this NOFO will utilize a two-phase, milestone-driven cooperative agreement (UG3/UH3) funding mechanism.
In addition, an accompanying data coordinating center (DCC) application (U24), submitted under PAR-24-087 and proposing a data analysis and data management plan for the clinical project, is required. Both a CCC application and a corresponding DCC application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of NCCIH, applicants are encouraged to consult the NCCIH website (https://nccih.nih.gov/about/plans).
Applicants are encouraged to contact the appropriate Scientific/Research Contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.
Deadlines:
- Letter of Intent Due Date(s): 30 days prior to the application due date
- Application Due Date(s): Feb. 20, 2025; June 20, 2025; Feb 20, 2026; June 22, 2026
- AIDS Due Dates: March 10, 2025; July 14, 2025; March 17, 2026; July 14, 2026
PAR-24-275 Expiration Date July 15, 2026
This NOFO only accepts applications that are part of a collaborative set of multiple applications. This NOFO only accepts applications that are part of a collaborative set of multiple applications. A set must contain 2 applications one application to PAR-24-275 and one application to PAR-24-276.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The combined budgets of the CCC and DCC will be used to determine whether the policy regarding direct costs of $500,000 or more in any year will be applied (https://nccih.nih.gov/grants/policies/over500k-clinical-trials).