NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01 Clinical Trial Required) | PAR 18 118

Opportunity Information: Apply for PAR 18 118

The NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01 Clinical Trial Required), Funding Opportunity Number PAR 18-118, is a National Institutes of Health (NIH) discretionary funding opportunity from the National Center for Complementary and Integrative Health (NCCIH) under the health activity category (CFDA 93.213). It supports investigator-initiated clinical trials focused on mind and body interventions that align with NCCIH-designated areas of high research priority. The award mechanism is a cooperative agreement (U01), which typically means the funded project is carried out with substantial scientific and/or programmatic involvement from NIH staff compared to a standard research grant, while still remaining investigator-led.

The central purpose of this FOA is to move promising mind and body interventions toward the next stage of rigorous testing by funding clinical trials that refine, optimize, and strengthen the evidence base needed before launching a larger, definitive multi-site trial. Proposed studies are expected to do more than simply ask whether an intervention works. Instead, they should be designed to develop and test adaptive interventions, optimize complex interventions by identifying which components are truly driving changes in outcomes, and/or demonstrate that an intervention can be delivered consistently (with fidelity) across more than one site in a way that would support a future large-scale trial. Another allowable direction is collecting key preparatory preliminary data that would reduce uncertainty in a later multi-site study, such as determining the most appropriate intervention dose, duration, or frequency.

A major emphasis of the announcement is readiness. Applicants are expected to already have solid preliminary data in hand showing that the proposed work is feasible and that the intervention has credible promise of clinical benefit. The FOA explicitly points to the kinds of readiness evidence reviewers will expect, including proof that recruitment and accrual are workable, that participants can and will adhere to the intervention protocol, and that retention is strong enough to complete the study and final outcome data collection. It also stresses that any related or precursor studies should have completed final data collection, reinforcing the expectation that the fieldwork is mature enough to justify a cooperative agreement clinical trial rather than an early exploratory project.

This FOA is also clear about what it does not fund. It is not intended to support full-scale multi-site efficacy or effectiveness trials, meaning it is not meant to be the final, definitive trial intended to change clinical practice on its own. It also will not support clinical trials testing mind and body interventions for the treatment or prevention of cancer, which would need to be pursued through other NIH or institute-specific opportunities.

Eligibility is broad and includes many common public, private, academic, nonprofit, and governmental applicant types. Eligible applicants listed include state, county, 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible entities 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, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations.

In terms of basic timeline metadata provided, the opportunity was created on 2017-11-02, and the original closing date shown is 2020-06-29. The excerpted source information does not provide an award ceiling or an expected number of awards, so those details would typically need to be confirmed in the full FOA or related NIH guide notices. Overall, this program is best understood as targeted support for well-prepared, investigator-initiated mind and body clinical trials that are specifically designed to optimize interventions and de-risk the design of a later, larger multi-site trial, rather than to conduct the definitive large trial itself.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01 Clinical Trial 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 2017-11-02.
• Applicants must submit their applications by 2020-06-29. (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.

Apply for PAR 18 118

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: