NCCIH Natural Product Mid Phase Clinical Trial
Funds the mid-phase study that settles a natural product's dose, formulation or responder group before anyone commits to a multi-site efficacy trial.
This is the third and last step of the natural product pathway, and the one that decides what a full efficacy trial would actually test.
The entry condition is heavy. An application must bring preliminary data showing bioavailability where that applies, and documentation that the product produces a reproducible, measurable impact on target engagement — the mechanism of action, measured. That requ…
Mid-phase clinical trials of natural products — botanicals, dietary supplements, probiotics and standardised nutritional regimens — determining optimal dose or formulation, or identifying responder and non-responder phenotypes, ahead of a future multi-site efficacy trial. Requires preliminary bioavailability and reproducible target-engagement data. Efficacy and effectiveness trials are not supported.
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