Dataset Information

Improving natural product research translation: From source to clinical trial.

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.

SUBMITTER: Sorkin BC

PROVIDER: S-EPMC7470648 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Improving natural product research translation: From source to clinical trial.

Sorkin Barbara C BC Kuszak Adam J AJ Bloss Gregory G Fukagawa Naomi K NK Hoffman Freddie Ann FA Jafari Mahtab M Barrett Bruce B Brown Paula N PN Bushman Frederic D FD Casper Steven J SJ Chilton Floyd H FH Coffey Christopher S CS Ferruzzi Mario G MG Hopp D Craig DC Kiely Mairead M Lakens Daniel D MacMillan John B JB Meltzer David O DO Pahor Marco M Paul Jeffrey J Pritchett-Corning Kathleen K Quinney Sara K SK Rehermann Barbara B Setchell Kenneth D R KDR Sipes Nisha S NS Stephens Jacqueline M JM Taylor D Lansing DL Tiriac Hervé H Walters Michael A MA Xi Dan D Zappalá Giovanna G Pauli Guido F GF

FASEB journal : official publication of the Federation of American Societies for Experimental Biology 20191210 1

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, 20 ...[more]

PMID: 31914647

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Project description:One in four Americans, and 70% of people who have dementia, will spend their final days in nursing home care. Clinical research, particularly clinical trials, rarely includes this population due to unique challenges in research methods and ethics. Families of advanced dementia patients make choices about tube feeding and other feeding options with limited access to information or communication. The cluster randomized trial, Improving Decision Making about Feeding Options for Dementia Patients, tests a decision aid intervention to improve the quality of decision making for this choice.Our objectives are (1) to describe the methods used in this trial; (2) to describe challenges and strategies for effective nursing home and nursing home resident recruitment and retention; and (3) to describe research ethics approaches to minimize harms and maximize benefits for this population.The study is a cluster randomized trial of a decision aid to inform and support the choice between tube feeding and assisted oral feeding in advanced dementia. Study subjects are paired surrogate decision makers and residents with advanced dementia and feeding problems, enrolled from nursing homes in North Carolina.This trial enrolled 256 paired surrogate decision makers and residents in 24 nursing home sites, and 99% completed participation through the 3-month study period. The research team had prior clinical and investigative experience in this setting, and used multiple strategies to recruit and retain nursing home sites, providers, surrogates, and the residents for whom they spoke. Informed consent and human subjects' protections were designed to address the vulnerability of this population.Cluster randomization was necessary to avoid contamination between control and intervention subjects, but may introduce confounding by site and intracluster correlation effects in analyses.Strategies that facilitate nursing home recruitment, participant recruitment and protection of human subjects for a vulnerable population may be used by future investigators to expand the research evidence base for nursing home and dementia care.

Dataset Information

Improving natural product research translation: From source to clinical trial.

Publications

Improving natural product research translation: From source to clinical trial.

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