NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award
Funds three years of pharmacokinetics and target-engagement work on a botanical, probiotic or supplement, then three more if the milestones are met.
Natural products fail in trials for a reason that has nothing to do with whether they work: nobody established what dose reaches the target, or whether it engages the target at all. The National Center for Complementary and Integrative Health funds that groundwork before anyone asks about clinical benefit.
The products in scope are botanicals, probiotics, and things sold as dietary supplements. Nโฆ
Early-phase clinical trials of natural products โ botanicals, probiotics, dietary supplements and standardised nutritional regimens โ with a first phase of milestone-driven pharmacokinetics, bioavailability and target-engagement measurement in humans, and a second phase replicating target engagement and testing its association with clinical outcomes. Trials must be designed so positive and negative results are equally informative.
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