NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)

The National Center for Complementary and Integrative Health (NCCIH) is welcoming applications for its Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required) funding opportunity. The aim of this opportunity is to encourage researchers to conduct mid-phase clinical trials of natural products, including botanicals, dietary supplements, and probiotics.

This funding would be particularly suitable for trials that have a strong scientific premise and compelling preliminary evidence to justify further clinical testing. Examples of such products could include nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound, like omega-3 fatty acids, anthocyanidins, or polyphenols.

Any application must be backed by adequate preliminary data that demonstrates both the bioavailability of the product (if applicable), and evidence that the natural product can produce a reliable and quantifiable impact on target engagement, which is the measure of the mechanism of action. The only exception to this will be in cases where measuring target engagement in the relevant patient population isn't possible or practical, or when there's already a basic understanding of the product's mechanism of action.

The funding opportunity expects that proposed clinical trials will aim to establish the optimal dose or formulation of the natural product for use in a future multi-site effectiveness trial, or will aim to differentiate patient phenotypes who will respond positively or negatively to the natural product in order to establish the criteria for inclusion/exclusion in the future effectiveness trial.

All clinical trials submitted must be based on a hypothesis, follow specific milestones, and align directly with NCCIH research priorities and mission. However, this funding opportunity doesn't support single-site or multi-site effectiveness trials, nor trials aiming to test natural products for cancer treatment or prevention. To ensure that proposals are well-tailored to the goals of the NCCIH, potential applicants are encouraged to contact the relevant NCCIH Scientific/Research representative for their scientific area prior to developing an application.