Publications : 2018

Wikoff D. Moving beyond theory to the use of systematic review to support regulatory decision making for evidence-based risk assessment. Society of Toxicology Annual Meeting. March 11–15, 2018. San Antonio, TX.


The use of systematic review and evidence-based methodologies in toxicology and risk assessment have evolved from theory to practice. This informational session seeks to provide an overview of the landscape of the use of systematic review in regulatory decision making. Recognizing that there are many efforts to advance the science in this arena, this session will focus on efforts specifically associated with riskbased practices, such as development of health-based benchmarks (e.g., acceptable daily intakes, reference doses, etc.) rather than characterization of potential hazard (e.g., likelihood to be a hazard to humans for a given health outcome). Tools and frameworks initially developed for the field of medicine have been adapted for application to toxicological research questions, and in many cases, new tools have been developed. The presentations will describe how the regulatory practitioners have addressed the challenges of toxicological data relative to that of medicine. Examples will include addressing challenges in evaluating exposures vs. interventions, multi-endpoint vs. single-endpoint outcomes, well-defined diseases or conditions, complex data that is often not in humans (but rather in experimental animal studies or in vitro studies) vs. randomized controlled trials in humans, and evaluation of mixtures vs. pure substances. Beyond evaluation of individual studies and qualitative characterizations of hazards, approaches to integrate data in the context of risk—to be evaluated on a common metric, to develop health based-benchmarks—have been developed and applied. These concepts must be balanced with the rigor of a systematic review, a component which translates into time and resources. It is anticipated that this session will provide practical information for toxicologists and risk assessors and facilitate an understanding of how systematic review is being utilized in support of risk-based chemical assessments. Notably, speakers also will highlight how systematic review provides additional rigor and transparency, as well as relevance, of the process in decision making for regulated chemicals.