Building a Foundation for Clinical Trials of Natural Products
September 27, 2016
Over the years, I have often been asked whether the National Center for Complementary and Integrative Health (NCCIH) will fund clinical trials of natural products. The answer is, “Yes.” NCCIH funds clinical research of natural products, including herbal products, botanicals, products marketed as dietary supplements, and probiotics. However, it is critical for potential grant applicants to carefully consider whether compelling preclinical evidence is available and whether there is a solid foundation of basic mechanistic and pharmacologic data to warrant further clinical studies. NCCIH requires extensive preliminary data before trials are conducted to evaluate efficacy.
To help researchers obtain preliminary clinical data that will inform the design of a full-scale clinical trial, the Center has published two new funding opportunity announcements (FOAs) that take a phased approach to building scientific knowledge during the early stages of clinical testing:
- Exploratory Clinical Trials and Studies of Natural Products in NCCIH High Priority Research Topics (R61/R33) - PAR-16-418
- Exploratory Clinical Trials and Studies of Natural Products in NCCIH High Priority Research Topics (R33) - PAR-16-419
Register for a pre-application webinar on October 26, 2016
We’re holding a pre-application webinar for researchers to learn more about the new FOAs and the grant submission and review process. Please register and join us on Wednesday, October 26, at 2:30 p.m. ET for the NCCIH Natural Products Technical Assistance Webinar.
What is the difference between the two FOAs?
The first FOA, PAR-16-418, is a phased funding opportunity, and investigators must explain what activities will take place in both the R61 and R33 phases of the award. Investigators must propose specific and measurable milestones that will be met during the R61 phase.
The R61 phase will support studies to:
- Demonstrate whether the natural product can produce a measurable biological signature related to the potential mechanism of action when given to humans, or
- Demonstrate bioavailability and collect short-term pharmacokinetic or pharmacodynamics data.
The R33 phase will support studies to:
- Demonstrate whether the biological signature measured in the R61 can be replicated in a second human study,
- Assess the association between the degree of impact on the biological signature and functional or clinical outcomes in a patient population,
- Collect pharmacokinetic or pharmacodynamics data to assure proper dosing of the products, or
- Determine the optimal dose of the natural product for use in a future efficacy study based on impact on optimizing the impact on the biological signature.
The second FOA, PAR-16-419, would be useful for investigators who already have data to demonstrate that the specific natural product to be used in the study:
- Impacts the proposed biological signature when used by humans, and
- Is bioavailable in humans.
Are there any new requirements for the application?
Both funding opportunities require three special attachments: 1) a protocol synopsis, 2) a summary table of clinical trial experience, and 3) a Regulatory Communication Plan describing communications with the U.S. Food and Drug Administration regarding whether an Investigational New Drug application is needed for the proposed studies. Applications submitted without these attachments will be withdrawn and not reviewed.
What are the high program priority areas for these FOAs?
NCCIH has identified two general areas of high program priority for these FOAs:
- Symptom management, especially the use of natural products for sleep issues, pain management, or mental health conditions that are commonly managed in primary care
- Studies that examine the effects of probiotics and other natural products on gut microbiome interactions with the brain or the immune system.
We will not use these FOAs to fund clinical trials that test efficacy or effectiveness. We also will not fund research that tests natural products for the treatment or prevention of cancer.
Consult with NCCIH
After carefully reading through the FOAs and developing a draft set of specific aims for an application, we encourage you to contact an NCCIH program director to discuss whether your proposed study is a fit for this funding opportunity.
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