Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 - Clinical Trials Required) | PAR 18 417

Opportunity Information: Apply for PAR 18 417

The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), offered this discretionary grant opportunity (PAR 18-417) to fund feasibility-stage clinical trials of mind and body interventions focused on NCCIH-designated high priority research topics. The mechanism is an R34, which is typically used to support early clinical trial work that de-risks and prepares a later, larger study. The central purpose is to generate practical, decision-making evidence about whether and how a mind-body approach can be tested in a full-scale trial that could ultimately matter for public health.

This FOA is specifically geared toward exploratory or early phase clinical trials rather than definitive efficacy or effectiveness testing. In other words, the emphasis is on collecting the kinds of data investigators need before launching a major controlled cohort study, a full clinical efficacy/effectiveness trial, or a pragmatic trial. Projects are expected to fill key scientific and operational gaps that commonly derail or weaken larger trials, such as uncertainty about recruitment and retention, intervention adherence, acceptability to participants, feasibility of delivering the intervention with fidelity, refinement of dosing or intervention parameters, suitability and timing of outcome measures, preliminary estimates needed for future sample size calculations, and identification of logistical barriers or site-level challenges. The expectation is that the feasibility trial will directly inform a strong, competitive application for a subsequent full-scale clinical trial.

At the same time, the announcement draws clear boundaries around what it will not support. It is not meant for randomized clinical trials whose primary purpose is to determine or confirm efficacy or effectiveness. It also does not support projects that are essentially administrative preparations only, such as proposals focused solely on writing a protocol, developing a manual of operations, or building general clinical trial infrastructure without actually conducting the feasibility clinical trial and producing actionable data. The underlying idea is that awardees should come out of the R34 period with concrete findings that justify and shape a larger trial, not just plans to do one.

The opportunity falls under the health funding activity category and is associated with CFDA number 93.213. The funding instrument is a grant, and while the source text does not provide an award ceiling or the expected number of awards, it identifies an original closing date of January 7, 2021, and a creation date of November 29, 2017. In practical terms, this was a time-limited opportunity in which applicants competed to demonstrate that their proposed feasibility trial addressed an NCCIH high priority topic and that the results would credibly position the team to mount a later trial with real potential for public health impact.

Eligibility is broad and includes many types of domestic organizations and government entities, as well as certain non-U.S. participants. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, Indian/Native American tribal governments other than federally recognized, and non-domestic (non-U.S.) entities/foreign organizations.

Overall, the program is best understood as a launchpad for mind-body intervention research: it funds the early clinical trial work needed to prove that a larger study is practical, well-designed, and worth the investment. The desired endpoint is not a final verdict on whether an intervention works, but a high-quality feasibility evidence package that supports a subsequent, adequately powered trial that could meaningfully influence clinical practice and public health if successful.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 - Clinical Trials Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213.
• This funding opportunity was created on 2017-11-29.
• Applicants must submit their applications by 2021-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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