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NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required)

List of required information for application:

1. Investigator-initiated mid-phase clinical trial proposal for natural products

2. Sufficient preliminary data on bioavailability of the natural product

3. Documentation of replicable and measurable impact on a biological signature (mechanism of action)

4. Justification for waiving preliminary data requirement if unable to measure a biological signature in the patient population of interest or if there is a fundamental understanding of the product's mechanism of action

5. Clear objectives and goals for the mid-phase clinical trial, including determining optimal dose or formulation of the natural product or identifying patient phenotypes that respond or do not respond to the product

6. Hypothesis-based approach to the clinical trial

7. Milestone-driven plan for the clinical trial

8. Alignment with the research priorities and mission of NCCIH

9. Exclusion of single-site or multi-site efficacy or effectiveness trials

10. Exclusion of trials for the treatment or prevention of cancer

11. Contact information for the appropriate NCCIH Scientific/Research contact for the area of science related to the application, for pre-submission consultation.

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Funding Amount

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Eligible Applicants

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Eligible Activities

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Deadline to Apply

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88%

Approval rating across all Canadian funding programs

93%

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