| Autor: |
Barbara C Sorkin, Adam J Kuszak, Naomi K Fukagawa, Freddie Ann Hoffman, Mahtab Jafari, Bruce Barrett, Paula N. Brown, Frederic D. Bushman, Steven Casper, Floyd H. Chilton, Christopher S. Coffey, Mario G. Ferruzzi, D. Craig Hopp, Mairead Kiely, Daniel Lakens, John B. MacMillan, David Meltzer, Marco Pahor, Jeffrey Paul, Kathleen Pritchett-Corning, Sara Quinney, Barbara Rehermann, Kenneth D.R. Setchell, Nisha S. Sipes, Jacqueline M. Stephens, D. Lansing Taylor, Herve Tiriac, Michael Walters, Dan Xi, Giovanna Zappala, Guido Pauli |
| Rok vydání: |
2019 |
| Předmět: |
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| Popis: |
While great interest in health effects of natural product (NP) foods and dietary supplements 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: NPcharacterization 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. NPCTsprioritized 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 |
| Externí odkaz: |
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