Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required) | PAR 24 090

Frequently Asked Questions (FAQs) - NIH NCCIH Clinical Coordinating Center (PAR-24-090)

What is this funding opportunity?

This is an NIH National Center for Complementary and Integrative Health (NCCIH) cooperative agreement opportunity (PAR-24-090) to support a Clinical Coordinating Center (CCC) for an investigator-initiated, fully powered, multi-site clinical trial focused on complementary and integrative health approaches.

What kind of clinical trial is NCCIH looking for under this opportunity?

The supported project is a late-phase, fully powered, multi-site clinical trial (Phase III and beyond). The CCC application is expected to include a complete scientific and operational plan for executing a credible, generalizable multi-site trial.

What research approaches are in scope for the trial?

The trial must study mind and body interventions, defined here as approaches that use physical and/or psychological therapeutic inputs. The trial may also include broader multicomponent interventions that combine physical, psychological, and/or nutritional elements.

Does the proposed trial need to align with NCCIH priorities?

Yes. NCCIH is aiming for projects in its designated high-priority research areas, and applicants are expected to align the proposed clinical question and study design with NCCIH's mission, strategic vision, and research priorities described on the NCCIH website.

What is the role of the Clinical Coordinating Center (CCC) in this NOFO?

The CCC serves as the operational and scientific backbone of the multi-site trial. The application should describe how the study will be organized across sites, how the intervention will be delivered consistently, how protocol adherence and quality will be monitored, and how the trial will be executed to produce credible, generalizable results.

Is this NOFO funding the clinical trial concept only, or the full operational plan?

This NOFO is specifically for the CCC role and expects more than a high-level idea. The CCC application needs to include a clear scientific rationale and a complete scientific and operational plan for carrying out a Phase III (and beyond) multi-site trial.

What operational elements is the CCC expected to address in the application?

Based on the provided description, the CCC should lay out concrete plans for multi-site organization and execution, including intervention consistency, protocol adherence monitoring, quality oversight, project management structures, recruitment and retention strategies, and responsible scientific conduct with oversight and performance tracking.

What is the UG3/UH3 mechanism and why is it used here?

This opportunity uses a milestone-driven, two-phase UG3/UH3 cooperative agreement mechanism. The project starts with a time-limited UG3 phase to support planning and start-up activities tied to specific milestones, then moves to the UH3 phase for full implementation once milestones are met. This is intended to reduce the risk of launching large, expensive multi-site trials before readiness is demonstrated.

What kinds of milestones and decision points should applicants be prepared to propose?

Applicants should be prepared to define measurable milestones and decision points such as finalizing study protocols and manuals of procedures, obtaining regulatory approvals, confirming site readiness, demonstrating feasible recruitment pipelines, and establishing intervention fidelity and data flow processes that can support a large-scale trial.

Can the CCC award be submitted and funded on its own?

No. The CCC award cannot stand alone. NCCIH requires a paired, companion application for a Data Coordinating Center (DCC) using the U24 mechanism under PAR-24-087.

What is the Data Coordinating Center (DCC) expected to do, and how does it relate to the CCC?

The DCC is expected to propose and lead the data management and statistical/data analysis infrastructure for the same clinical project. The CCC focuses on trial leadership and operations across clinical sites, while the DCC focuses on data systems, data quality, and analysis plans. The applications should be tightly integrated, with aligned timelines, shared governance, and a clear division of responsibilities.

Do the CCC and DCC applications need to be submitted together?

Yes. Both the CCC (UG3/UH3) and DCC (U24) applications must be submitted at the same time for NCCIH to consider the overall program.

How involved will NCCIH be during the project?

Because this is a cooperative agreement, NCCIH will have substantial involvement compared with a typical research project grant. The CCC application is expected to include performance milestones and operational plans that can be monitored over time.

Is a dissemination plan required?

Yes. The CCC application is expected to include a dissemination plan describing how results will be communicated to scientific audiences and other stakeholders.

Does NCCIH recommend contacting NIH staff before submitting?

Yes. NCCIH encourages applicants to contact the relevant NIH scientific or research staff before submission, which can help confirm fit with NCCIH priorities and ensure the proposed trial design matches expectations for a multi-site, late-phase study.

Who is eligible to apply?

Eligibility is broad for domestic U.S. organizations and governments. Examples listed include state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities listed in the notice.

Are community-centered or mission-relevant institution types specifically mentioned?

Yes. The NOFO highlights inclusion of institution types and community-centered organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, among others.

Are non-U.S. (foreign) organizations eligible to apply as the applicant organization?

No. Non-U.S. (foreign) organizations are not eligible to apply as the applicant organization for this opportunity.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are not eligible under this opportunity.

Can a project include any foreign collaboration at all?

Foreign components may be allowed as defined in NIH policy. That means certain limited collaborations outside the U.S. can potentially be included if they meet NIH requirements, even though foreign organizations cannot serve as the applicant organization and non-U.S. components of U.S. organizations are not eligible.

What is the funding instrument and category?

This is a discretionary NIH funding opportunity using the cooperative agreement instrument, in the health funding category.

What CFDA number is associated with this opportunity?

The opportunity is associated with CFDA 93.213.

What are the key dates mentioned in the provided information?

The opportunity was created on December 20, 2023, and the original closing date listed is July 16, 2024.

Does the provided excerpt specify an award ceiling or the expected number of awards?

No. The provided excerpt does not specify an award ceiling or the expected number of awards. Applicants would need to consult the full announcement and related NIH guidance for budget expectations, review criteria, and detailed requirements for the UG3/UH3 milestones and the companion U24 DCC application.

Where should applicants look for details not included in the excerpt (budget, review criteria, and full requirements)?

The excerpt indicates that applicants should consult the full announcement and related NIH guidance for budget expectations, review criteria, and the detailed requirements for the UG3/UH3 milestones and the companion U24 DCC application.