NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)

The National Center for Complementary and Integrative Health (NCCIH) is launching the Natural Product Early Phase Clinical Trial Award. Aimed at advancing the study of natural products like botanicals, dietary supplements, and probiotics, this program will fund investigator-initiated, early-stage clinical trials. The initiative specifically calls for studies exploring natural products that hold promise as nutritional regimens, such as those containing omega-3 fatty acids, anthocyanidins, or polyphenols.

The main objective of these trials is to evaluate various natural products, providing valuable scientific insights for their further development and testing. Each trial must yield high-quality scientific data, regardless of whether the results are favorable or unfavorable. The trials should replicate the impact that these natural products have on target engagement in humans and establish a correlation between this impact and the patient's functional or clinical outcomes.

Researchers may propose trials that explore the impact of the natural product on target engagement by examining varying doses or formulations to optimize its impact. Studies may also investigate combining the natural product with another treatment, or researching its effects on a preferentially responsive target population. It is crucial that these clinical trials are driven by a specific hypothesis and directly related to NCCIH's research priorities and mission.

The funding mechanism, known as R33, seeks to facilitate the transfer of emerging basic science findings about natural products into early-stage clinical testing. Its purpose is to verify if further clinical research into these natural products is justified. Please note, this program does not support efficiency or effectiveness trials.