TY - JOUR
T1 - Improving natural product research translation
T2 - From source to clinical trial
AU - Sorkin, Barbara C.
AU - Kuszak, Adam J.
AU - Bloss, Gregory
AU - Fukagawa, Naomi K.
AU - Hoffman, Freddie Ann
AU - Jafari, Mahtab
AU - Barrett, Bruce
AU - Brown, Paula N.
AU - Bushman, Frederic D.
AU - Casper, Steven J.
AU - Chilton, Floyd H.
AU - Coffey, Christopher S.
AU - Ferruzzi, Mario G.
AU - Hopp, D. Craig
AU - Kiely, Mairead
AU - Lakens, Daniel
AU - MacMillan, John B.
AU - Meltzer, David O.
AU - Pahor, Marco
AU - Paul, Jeffrey
AU - Pritchett-Corning, Kathleen
AU - Quinney, Sara K.
AU - Rehermann, Barbara
AU - Setchell, Kenneth D.R.
AU - Sipes, Nisha S.
AU - Stephens, Jacqueline M.
AU - Taylor, D. Lansing
AU - Tiriac, Hervé
AU - Walters, Michael A.
AU - Xi, Dan
AU - Zappalá, Giovanna
AU - Pauli, Guido F.
N1 - Funding Information:
The authors thank Paul M. Coates, Joseph M. Betz, and F. Ellis McKenzie for inspiration and support, Wen Chen for help with the initial concept, Wendy P. O’Meara for insightful editing, Sharon Ross and Harold Seifried of the NIH National Cancer Institute for invaluable input into the workshop, Miriam Sander for workshop transcription and notes, Cara Lynch, James Hubley, Katy Fuller, and Joyce Merkel for outstanding technical support. This project was supported by staff and funding from the NIH’s Office of Dietary Supplements, National Cancer Institute, National Center for Complementary and Integrative Health, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, and National Institute of Environmental Health Sciences. Support was also provided by staff from the Food and Drug Administration and the US Department of Agriculture.
Funding Information:
The authors thank Paul M. Coates, Joseph M. Betz, and F. Ellis McKenzie for inspiration and support, Wen Chen for help with the initial concept, Wendy P. O?Meara for insightful editing, Sharon Ross and Harold Seifried of the NIH National Cancer Institute for invaluable input into the workshop, Miriam Sander for workshop transcription and notes, Cara Lynch, James Hubley, Katy Fuller, and Joyce Merkel for outstanding technical support. This project was supported by staff and funding from the NIH?s Office of Dietary Supplements, National Cancer Institute, National Center for Complementary and Integrative Health, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, and National Institute of Environmental Health Sciences. Support was also provided by staff from the Food and Drug Administration and the US Department of Agriculture.
Publisher Copyright:
© 2019 Federation of American Societies for Experimental Biology
PY - 2020/1/1
Y1 - 2020/1/1
N2 - 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.
AB - 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.
KW - clinical predictive validity
KW - dietary supplements
KW - model systems
KW - rigor and replicability
KW - value of information
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UR - http://www.scopus.com/inward/citedby.url?scp=85077737527&partnerID=8YFLogxK
U2 - 10.1096/fj.201902143R
DO - 10.1096/fj.201902143R
M3 - Review article
C2 - 31914647
AN - SCOPUS:85077737527
SN - 0892-6638
VL - 34
SP - 41
EP - 65
JO - FASEB Journal
JF - FASEB Journal
IS - 1
ER -