NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)

The National Center for Complementary and Integrative Health (NCCIH) has issued a Notice of Funding Opportunity (NOFO) aimed to propel early-phase clinical trials of natural products, such as botanicals, probiotics, and dietary supplements. This NOFO is geared towards products with strong scientific grounding and promising nutritional values that justify further clinical testing. In particular, it focuses on nutritional compounds like omega-3 fatty acids, anthocyanidins, and polyphenols.

With this funding, trial designs should be such that they yield significant scientific insights, regardless of positive or negative outcomes, thereby informing decisions about further research and development of the tested natural product. The funding will cover up to three years (R61 phase) of support needed for measuring pharmacokinetics and bioavailability, assessing how these natural products function when used by humans, and testing their effects on a pre-determined target.

Provided that specified milestones are accomplished during the R61 phase, an additional support of up to three years may be granted for the R33 phase. During this phase, the award aims to replicate the natural product's impact on the target and examine a possible association between the product's impact degree on the target and clinical outcomes in a population of participants.

Applicants are enthusiastically invited to propose R33 phase studies on how to optimize the impact of natural products by adjusting the dosage or formulation used. They can also explore pairing the natural product with another recognized treatment to enhance the effects further. The study can also be designed to examine the impact of natural products on populations that are more likely to respond to the treatment.