Authors

Barbara C. Sorkin, National Institutes of Health (NIH)
Adam J. Kuszak, National Institutes of Health (NIH)
Gregory Bloss, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Naomi K. Fukagawa, USDA Agricultural Research Service, Washington DC
Freddie Ann Hoffman, HeteroGeneity, LLC
Mahtab Jafari, University of California, Irvine
Bruce Barrett, University of Wisconsin-Madison
Paula N. Brown, British Columbia Institute of Technology
Frederic D. Bushman, University of Pennsylvania
Steven J. Casper, Food and Drug Administration
Floyd H. Chilton, The University of Arizona
Christopher S. Coffey, University of Iowa
Mario G. Ferruzzi, NC State University
D. Craig Hopp, National Institutes of Health (NIH)
Mairead Kiely, University College Cork
Daniel Lakens, Technische Universiteit Eindhoven
John B. MacMillan, University of California, Santa Cruz
David O. Meltzer, The University of Chicago Medicine
Marco Pahor, University of Florida
Jeffrey Paul, College of Medicine
Kathleen Pritchett-Corning, Harvard University
Sara K. Quinney, Indiana University-Purdue University Indianapolis
Barbara Rehermann, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Kenneth D.R. Setchell, Cincinnati Children's Hospital Medical Center
Nisha S. Sipes, National Institute of Environmental Health Sciences (NIEHS)
Jacqueline M. Stephens, Louisiana State University
D. Lansing Taylor, University of Pittsburgh
Hervé Tiriac, University of California, San Diego
Michael A. Walters, College of Pharmacy
Dan Xi, National Cancer Institute (NCI)
Giovanna Zappalá, National Institute on Aging (NIA)
Guido F. Pauli, University of Illinois at Chicago

Document Type

Article

Publication Date

1-1-2020

Abstract

© 2019 Federation of American Societies for Experimental Biology While great interest in health effects of natural product (NP) including dietary supplements and foods persists, promising preclinical NP research is not consistently translating into actionable clinical trial (CT) outcomes. Generally considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are costly and require rigorous planning to optimize the value of the information obtained. More effective bridging from NP research to CT was the goal of a September, 2018 transdisciplinary workshop. Participants emphasized that replicability and likelihood of successful translation depend on rigor in experimental design, interpretation, and reporting across the continuum of NP research. Discussions spanned good practices for NP characterization and quality control; use and interpretation of models (computational through in vivo) with strong clinical predictive validity; controls for experimental artefacts, especially for in vitro interrogation of bioactivity and mechanisms of action; rigorous assessment and interpretation of prior research; transparency in all reporting; and prioritization of research questions. Natural product clinical trials prioritized based on rigorous, convergent supporting data and current public health needs are most likely to be informative and ultimately affect public health. Thoughtful, coordinated implementation of these practices should enhance the knowledge gained from future NP research.

Publication Source (Journal or Book title)

FASEB Journal

First Page

41

Last Page

65

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