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

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.

The Alcohol Policy Information System (APIS) and policy research At NIAAA.

Public policies have the potential to prevent the adverse consequences of alcohol consumption on a larger scale than any other category of interventions. However, measuring the effects of specific policies on alcohol-related behaviors and health outcomes is difficult and presents a variety of daunting challenges. One important challenge stems from the nonexperimental nature of most policy research, which makes it difficult to distinguish between causal relationships and noncausal associations. Another key challenge arises from the complexity of alcohol-related behaviors and outcomes and the wide range of potential effects that specific policy interventions may have on different groups and actors in various contexts. A third important challenge involves the difficulty in accurately characterizing the policies to be studied, which can be attributed largely to the arcane legal framework of statutes and regulations in which policies are created. This challenge is magnified by the enormous variety of alcohol-related public policies that have been adopted at all levels of government and the myriad variations in specific provisions that are embedded in the laws and regulations. Valid analysis of policy effects depends on surmounting all of these challenges and accurately characterizing policies and discerning the true causal effects of those policies on well-specified outcomes of interest.

Measuring the health consequences of alcohol consumption: current needs and methodological challenges.

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.

The Economic Cost of FAS.

Estimates of the total cost of FAS are highly dependent on factors such as incidence rates for the disorder. Estimates of the lifetime costs involved with a single case of FAS may be more valuable.