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 Septe mber, 2018 trans disci plina ry 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. K E Y W O R D S clinical predictive validity, dietary supplements, model systems, rigor and replicability, value of information | 43 SORKIN et al.still provide invaluable guidance, the results of such trials are often met with concerns that different design choiceswhether of product, dose, timing, participant eligibility criteria, outcomes, etc.-might have yielded a substantially different result. Each interventional trial represents a substantial investment, with well-powered Phase III CTs typically consuming more than $10 million and many person-years. 9,10 Additionally, as time and funds are limited, and participant pools may also be constrained, a decision to invest in a CT often precludes pursuing other research questions, 11 which may provide more useful public health-relevant knowledge than an RCT with an insufficient evidence base.

Background/Aims: Extensive research has shown that alcohol consumption leads to poor health and premature death through its causal or contributing roles in numerous chronic health conditions and acute health outcomes, including various cancers, liver disease, and injuries. Paradoxically, advances in understanding of the causal associations between alcohol consumption and various conditions have complicated our ability to discern trends in the health consequences of alcohol consumption over time. Methods: Four distinct needs for information on alcohol’s role in causing adverse health outcomes are identified. Estimates of alcohol-attributable mortality from two US studies are compared and differences identified. Results: Differences in the conditions included and alcohol-attributable fractions employed accounted for large differences in the estimated alcohol-attributable mortality for several health outcomes. Conclusion: Despite the broad consensus on many health consequences of alcohol consumption, further research is needed to clarify the conditions that are caused by alcohol consumption, magnitudes of causal relationships, and effects of different patterns of consumption and individual characteristics. Comparisons over time are needed to identify areas where improvements in public health may be occurring or are most needed, to support evaluation of specific interventions, and to encourage the public awareness of alcohol problems that is necessary to change attitudes and behaviors involving alcohol consumption.

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