Project Concept Review
Council Date: June 7, 2013
Program Officers: Barbara C. Sorkin, Office of Dietary Supplements (ODS), NIH and D. Craig Hopp, Ph.D., National Center for Complementary and Alternative Medicine (NCCAM), NIH
The World Health Organization estimates that about 80% of the world population relies on traditional medicines prepared from natural products, while 25% of all pharmaceuticals prescribed are derived from plants. In the U.S., many commonly used dietary supplements are botanicals or derived from botanicals. Despite their prevalent use, the mechanisms of action, safety and efficacy of many botanicals have not been rigorously evaluated. The ODS has a Congressional mandate to support research to address this gap. Since 1999 ODS has fulfilled this mandate by partnering with NCCAM and other NIH components to support the Botanical Research Centers Program.
This proposed initiative is based on the deliberations of an Expert Panel convened by the ODS and NCCAM on April 29, 2013, to provide input on approaches to strengthen our ongoing investment in botanical research. The Panel noted that the inherently variable, multi-component composition of botanicals adds a layer of complexity beyond that common in biomedical research. The active constituents may not be known, and components may interact in complex ways to modify bioactivity. The botanicals studied typically have a history of human use which may be leveraged in exploring clinically relevant questions, e.g., it may suggest an increased focus on outcomes related to health and resiliency. Prevalence of use may also contribute to prioritization of research. Given the magnitude of the resources required to rigorously design and conduct in vivo trials of botanical products, more efficient approaches are needed to advance this research. Collaborative interdisciplinary efforts including a wide range of research expertise, and efforts to increase interdisciplinary collaboration and coordination with a variety of relevant of institutions (government, academic, private) will be required.
Purpose of Proposed Initiative
The ODS and NCCAM seek to enhance progress in the understanding of botanicals used for human health by supporting interdisciplinary research to develop, or adapt from other fields, cutting-edge approaches that will contribute to the ability to rapidly assess the identity, content and potential of botanical products for specific health-related bioactivities, including potential interactions. In addition, these efforts are anticipated to contribute to the development of a scientific “scaffold” that will facilitate dissemination of state-of-the-art knowledge and other resources as appropriate.
Through a renewed Botanical Research Centers initiative, the ODS and NCCAM propose to solicit and support cutting-edge, interdisciplinary, multi-component research efforts. The Centers are expected to significantly advance the full range of health-related botanical research, including, but not limited to, developing improved (e.g., faster, more comprehensive and/or more accurately predictive) approaches to:
- Product identification and characterization,
- Elucidation of mechanisms of action, contributing chemical entities (including endophyte-derived products), and inter-component interactions,
- Assess modulation of botanical activities (including metabolism, safety and efficacy) by host characteristics such as genetics and environment (including, but not limited to, the gut microbiome).
We anticipate that conduct of this research will include and entail:
- Application of state-of-the-art approaches, as well as the development of new methods or adaptation of cutting-edge methodologies from allied fields.
- Providing an environment suitable for the training of investigators able to design, conduct and participate in interdisciplinary botanical research, and coordination with funding approaches that provide training support.
- Contributing to a scientific “scaffold” from which researchers, reviewers, research funders and others can draw to access state-of-the art approaches.