1. Name of the grant: NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
2. Grant description: This FOA encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Trials must be designed to provide information of high scientific utility and support decisions about further development or testing of the natural product. The FOA provides up to two years (R61 phase) of support for milestone-driven testing of bioavailability, pharmacokinetics, and assessment of the natural product's effect on a biological signature(s). If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact on the biological signature(s) and assess whether there is an association with functional or clinical outcomes in a patient population. R33 studies can optimize the impact of the natural product by dose/formulation, combining it with another treatment, or studying a more responsive target population. Clinical trials must be hypothesis-based, milestone-driven, and directly related to NCCIH research priorities and mission. The funding mechanism aims to accelerate the translation of basic science findings into early-stage clinical testing. The FOA does not support efficacy trials.
Required information for application:
1. Project title
2. Project abstract
3. List of investigators and their affiliations
4. Research plan describing the scientific premise and objectives of the trial
5. Description of the natural product being tested and its potential benefits
6. Detailed study design, including the specific bioavailability, pharmacokinetics, and assessment methods
7. Milestones for the R61 phase and criteria for determining success
8. Budget and budget justification for the R61 phase
9. Plan for patient recruitment and informed consent process
10. Data sharing and dissemination plan
11. Potential risks and safety measures for participants
12. Qualifications and experience of the investigative team
13. Compliance with ethical standards and human subject protection regulations
14. Project timeline and milestones for the R33 phase (if applicable)
15. Budget and budget justification for the R33 phase
16. Explanation of how the R33 phase will replicate and optimize the impact on the biological signature(s)
17. Justification for the chosen target population and any additional interventions or treatments being combined
18. Description of the expected functional
