Overview

A workshop, “Enhancing Natural Product Clinical Trials,” will be held on September 13-14, 2018 in Natcher Auditorium on the NIH Campus in Bethesda, Maryland.

The overall goal of this workshop is to enhance the progression of natural products research from foundational data (e.g., from preclinical and epidemiological research) to actionable public health information. The workshop will bring together trans-disciplinary experts for structured discussions of good practices for rigor in obtaining, reporting, interpreting and assessing foundational data for natural product clinical trials (NPCT), as well as for NPCT decision-making and design. Adoption of these good practices would be expected to enhance return on investment in NPCT.

The workshop will address the following:

  • Which foundational data are most important for learning as much as possible from each NPCT, whether or not the null hypothesis is disproven?
  • How might greater rigor in producing, analyzing, reporting, and assessing foundational data for NPCT—and/or more rigorous approaches to clinical trial design and decision-making—increase the fraction of trials that disprove the null hypothesis?
  • What data should be collected during a NPCT to maximize the acquisition of information that can enhance the design of future research, including further clinical trials, and/or contribute more directly to public health?

Workshop presentations will move between broad perspectives and specific illustrative examples. Moderated discussions will consider good practices and related research and resource needs. Summary publications of the workshop presentations and discussions are planned.

All persons are invited to attend, especially those with relevant research experience.

There is no registration fee for this workshop.  However, all those planning to attend, whether in person or by webinar, should register in advance of the workshop. 

This workshop is organized by the NIH Office of Dietary Supplements, in collaboration with the U.S. Food and Drug Administration, the U.S. Department of Agriculture, and the NIH National Cancer Institute, National Center for Complementary and Integrative Health, National Institute on Aging, National Institute of Environmental Health Sciences, and Office of Research on Women’s Health.