Clinical Coordinating Center for NCCIH Multi-Site Natural Products Clinical Trials

NOTE: This opportunity has expired (July 17, 2024). It has been reissued as PAR-24-312.

Research Focus

The National Center for Complementary and Integrative Health (NCCIH) seeks cooperative agreement applications to establish Clinical Coordinating Centers (CCCs) for investigator-initiated, multi-site clinical trials (Phase III and beyond) testing the efficacy or effectiveness of natural products—including botanicals, probiotics, dietary supplements, and standardized nutritional regimens (e.g., omega-3 fatty acids, anthocyanidins, polyphenols)—in NCCIH priority research areas. Trials must demonstrate target engagement (measurable effects on hypothesized molecular, cellular, biological, behavioral, or psychological targets) before or alongside clinical benefit assessment. The CCC will manage project operations, participant recruitment and retention, performance milestones, scientific conduct, and dissemination across multiple sites. A companion Data Coordinating Center (DCC) application under PAR-24-125 is required simultaneously; the DCC provides independent data management, biostatistical support, and sample size calculations to ensure study integrity and blinding.

At a Glance

• Who can apply: Institutions with clinical content expertise to conduct the proposed intervention; multi-site trials require ≥3 geographically distinct recruitment sites (2 sites permitted with strong justification for generalizability and diversity).
• Funding & project length: Not stated; two-phase milestone-driven cooperative agreement (UG3/UH3 mechanism).
• Award mechanism: UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement.
• Key dates: Posted February 2, 2024; open February 4, 2024; expired July 17, 2024 (reissued as PAR-24-312).
• Best fit for: Clinical researchers designing rigorous, multi-site efficacy or pragmatic randomized controlled trials of natural products with preliminary mechanistic and safety data; requires parallel DCC partnership.