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Improving natural product research translation: From source to clinical trial.
Sorkin, Barbara C; Kuszak, Adam J; Bloss, Gregory; Fukagawa, Naomi K; Hoffman, Freddie Ann; Jafari, Mahtab; Barrett, Bruce; Brown, Paula N; Bushman, Frederic D; Casper, Steven J; Chilton, Floyd H; Coffey, Christopher S; Ferruzzi, Mario G; Hopp, D Craig; Kiely, Mairead; Lakens, Daniel; MacMillan, John B; Meltzer, David O; Pahor, Marco; Paul, Jeffrey; Pritchett-Corning, Kathleen; Quinney, Sara K; Rehermann, Barbara; Setchell, Kenneth D R; Sipes, Nisha S; Stephens, Jacqueline M; Taylor, D Lansing; Tiriac, Hervé; Walters, Michael A; Xi, Dan; Zappalá, Giovanna; Pauli, Guido F.
Afiliação
  • Sorkin BC; Office of Dietary Supplements, National Institutes of Health (NIH), Bethesda, MD, USA.
  • Kuszak AJ; Office of Dietary Supplements, National Institutes of Health (NIH), Bethesda, MD, USA.
  • Bloss G; National Institute on Alcohol Abuse and Alcoholism, NIH, Bethesda, MD, USA.
  • Fukagawa NK; USDA ARS, Beltsville, MD, USA.
  • Hoffman FA; HeteroGeneity LLC, Washington, DC, USA.
  • Jafari M; University of California, Irvine, Irvine, CA, USA.
  • Barrett B; University of Wisconsin, Madison, WI, USA.
  • Brown PN; British Columbia Institute of Technology, Burnaby, BC, Canada.
  • Bushman FD; University of Pennsylvania, Philadelphia, PA, USA.
  • Casper SJ; Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA), Hyattsville, MD, USA.
  • Chilton FH; Department of Nutritional Sciences and the BIO5 Institute, University of Arizona, Tucson, AZ, USA.
  • Coffey CS; University of Iowa, Iowa City, IA, USA.
  • Ferruzzi MG; Plants for Human Health Institute, North Carolina State University, Kannapolis, NC, USA.
  • Hopp DC; National Center for Complementary and Integrative Health, NIH, Bethesda, MD, USA.
  • Kiely M; Cork Centre for Vitamin D and Nutrition Research, School of Food and Nutritional Sciences, University College Cork, Cork, Ireland.
  • Lakens D; Eindhoven University of Technology, Eindhoven, Netherlands.
  • MacMillan JB; University of California, Santa Cruz, Santa Cruz, CA, USA.
  • Meltzer DO; University of Chicago Medicine, Chicago, IL, USA.
  • Pahor M; University of Florida, Gainesville, FL, USA.
  • Paul J; Drexel Graduate College of Biomedical Sciences, College of Medicine, Evanston, IL, USA.
  • Pritchett-Corning K; Harvard University, Cambridge, MA, USA.
  • Quinney SK; Indiana University, Indianapolis, IN, USA.
  • Rehermann B; National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.
  • Setchell KDR; Cincinnati Children's Hospital, Cincinnati, OH, USA.
  • Sipes NS; National Institute of Environmental Health Sciences, NIH, Research Triangle Park, NC, USA.
  • Stephens JM; Louisiana State University, Baton Rouge, LA, USA.
  • Taylor DL; University of Pittsburgh, Pittsburgh, PA, USA.
  • Tiriac H; University of California, San Diego, La Jolla, CA, USA.
  • Walters MA; Institute for Therapeutics Discovery and Development, University of Minnesota, Minneapolis, MN, USA.
  • Xi D; Office of Cancer Complementary and Alternative Medicine, National Cancer Institute, NIH, Shady Grove, MD, USA.
  • Zappalá G; National Institute on Aging, NIH, Bethesda, MD, USA.
  • Pauli GF; CENAPT and PCRPS, University of Illinois at Chicago College of Pharmacy, Chicago, IL, USA.
FASEB J ; 34(1): 41-65, 2020 01.
Article em En | MEDLINE | ID: mdl-31914647
ABSTRACT
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Pesquisa Translacional Biomédica Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Animals / Humans Idioma: En Revista: FASEB J Assunto da revista: BIOLOGIA / FISIOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Pesquisa Translacional Biomédica Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Animals / Humans Idioma: En Revista: FASEB J Assunto da revista: BIOLOGIA / FISIOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos