Improving natural product research translation: From source to clinical trial.
clinical predictive validity
dietary supplements
model systems
rigor and replicability
value of information
Journal
FASEB journal : official publication of the Federation of American Societies for Experimental Biology
ISSN: 1530-6860
Titre abrégé: FASEB J
Pays: United States
ID NLM: 8804484
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
21
08
2019
revised:
12
10
2019
accepted:
21
10
2019
entrez:
10
1
2020
pubmed:
10
1
2020
medline:
14
7
2020
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 31914647
doi: 10.1096/fj.201902143R
pmc: PMC7470648
mid: NIHMS1610706
doi:
Substances chimiques
Biological Products
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
41-65Subventions
Organisme : NIA NIH HHS
ID : P30 AG028740
Pays : United States
Organisme : NCCIH NIH HHS
ID : R01 AT008621
Pays : United States
Organisme : Intramural NIH HHS
ID : Z99 OD999999
Pays : United States
Informations de copyright
© 2019 Federation of American Societies for Experimental Biology.
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