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Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required)

National Institutes of Health

The goal of this notice of funding opportunity (NOFO) is to support feasibility trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) for conditions that have been identified by NCCIH as high-priority research topics. This funding opportunity is intended to support feasibility clinical trials that provide new information that are scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIH’s mission. NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent competitive full-scale clinical trial. Under this R34, the data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial, including, but not limited to the following: examining feasibility and acceptability of interventions lacking published data; tailoring or adapting the content or structure of an intervention to a specific population, modality, or setting; refining the intervention to determine the most appropriate frequency or duration; determining feasibility of recruitment, retention, and data collection procedures; refining and assessing the feasibility of protocolized multi-component interventions; or examining acceptability and adherence of control conditions. The subsequent full-scale clinical trial should have the potential to make a significant impact on public health.

Prior to submitting to this NOFO, applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact person for the science area of the planned application.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

Deadlines:

Letter of Intent Due Date(s): 30 days prior to the application due date
R34 Due Dates: Feb 20, 2024; June 20, 2024; Oct 21, 2024; Feb 20, 2025; June 20, 2025; Oct 20, 2025; Feb 20, 2026; June 22, 2026; Oct 20, 2026
AIDS Due Dates: March 11, 2024; July 15, 2024; Nov 13, 2024; March 10, 2025; July 14, 2025; Nov 17, 2025; March 17, 2026; July 13, 2026; Nov 13, 2026

PAR-24-084 New Date November 14, 2026 (Original Date: November 14, 2027) per issuance of NOT-AT-24-036

Specialties

Medical

Medical - Clinical Science

Medical - Basic Science

Eligibility Requirements

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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