Improving Natural Product Research Translation: from Source to Clinical Trial

Autor: Jacqueline M. Stephens, Barbara C. Sorkin, Mahtab Jafari, Paula N. Brown, Naomi K. Fukagawa, D. Craig Hopp, Mario G. Ferruzzi, Kathleen R. Pritchett-Corning, Jeffrey Paul, Hervé Tiriac, Daniel Lakens, Bruce Barrett, Floyd H. Chilton, Sara K. Quinney, Dan Xi, Barbara Rehermann, John B. MacMillan, Freddie Ann Hoffman, Nisha S. Sipes, David O. Meltzer, Christopher S. Coffey, Adam J. Kuszak, Frederic D. Bushman, Kenneth D.R. Setchell, D. Lansing Taylor, Gregory Bloss, Giovanna Zappalà, Marco Pahor, Michael A. Walters, Mairead Kiely, Steven J. Casper, Guido F. Pauli
Přispěvatelé: Human Technology Interaction
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Prioritization
Predictive validity
medicine.medical_specialty
Biochemistry & Molecular Biology
Biomedical
Computer science
Physiology
Medical Physiology
Drug Evaluation
Preclinical
Ethnobotany
SDG 3 – Goede gezondheid en welzijn
Biochemistry
Article
Value of information
dietary supplements
model systems
Translational Research
Biomedical
03 medical and health sciences
0302 clinical medicine
rigor and replicability
SDG 3 - Good Health and Well-being
Clinical Research
Translational Research
Complementary and Integrative Health
Genetics
medicine
Animals
Humans
clinical predictive validity
Translational Medical Research
Molecular Biology
Biological Products
Public health
Preclinical
value of information
Clinical trial
030104 developmental biology
Good Health and Well Being
Risk analysis (engineering)
Drug Evaluation
Research questions
Biochemistry and Cell Biology
030217 neurology & neurosurgery
Biotechnology
Zdroj: FASEB J
The FASEB Journal, 34(1), 41-65. FASEB
FASEB journal : official publication of the Federation of American Societies for Experimental Biology, vol 34, iss 1
ISSN: 0892-6638
Popis: 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,2018transdisciplinaryworkshop. 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.
Databáze: OpenAIRE
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