Notice Number: NOT-AT-17-010

Key Dates
Release Date: May 11, 2017

Estimated Publication Date of Announcement: May 2017
First Estimated Application Due Date: October 2017
Earliest Estimated Award Date: August 2018
Earliest Estimated Start Date: August 2018

Issued by
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Purpose

The National Center for Complementary and Integrative Health intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications to support investigator-initiated early phase clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics).

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in Summer 2017 with an expected application due date in Fall 2017.

This FOA will utilize the R61/R33 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into this area of early-phase natural product clinical trials to begin to consider applying for this new FOA.

The goal of this initiative is to support investigator-initiated early phase clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics). Clinical trials of natural products are maximally informative if they incorporate well-formulated biological hypotheses, are built on a sound foundation of basic mechanistic and pharmacologic understanding, and incorporate assessment of defined replicable biological effects. Biological signatures of the natural products may be an objective single measure, proxy, correlate or combination of molecular/cellular, psychological, neural circuit, tissue/organ, and/or somatic changes. This initiative will require a measure of bioavailability of the natural product in human volunteers in the early phase natural product testing.

This initiative will used a phased award mechanism to support clinical trials that propose to measure the impact of the natural product on a biological signature in the first phase (R61); determine the reproducibility of the impact on the biological signature in a separate study in the second phase (R33); measure the correlation between the change in the biological signature and clinical outcomes (R33); determine the bioavailability and pharmacokinetics of the natural product (R61); and possibly determine the dose of the natural product that optimizes its impact on the biological signature (R33).

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Inquiries

Please direct all inquiries to:

Wendy Weber, ND, PhD, MPH
National Center for Complementary and Integrative Health
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov