Evidence-based approaches in toxicology: their origins, challenges, and future directions
Thomas Härtung, Katya Tsaioun
Abstract
Over the last 40 years, evidence-based practices and methods have revolutionized the practice of medicine, improved the standards of basic clinical research, and led to the broad adoption of evidence-based methods in clinical practice due to their transparency, consistency, and reproducibility. About 20 years ago, the first attempts to adapt this methodology to toxicology led to the humble beginnings of Evidence-based Toxicology (EBT). A milestone in this movement was a community-forming conference in Como, Italy, in 2007, which led to the formation of the Evidence-Based Toxicology Collaboration (EBTC) in 2011. EBTC has been building a community of EBT pioneers who are developing and disseminating these concepts. The expanding toolbox of systematic reviews, scoping reviews and evidence maps, is increasingly applied in already several thousand systematic reviews in environmental health. Increasingly, agencies such as the US Environmental Protection Agency, the US Food and Drug Administration and the European Food Safety Authority are actively testing and deploying these tools in their assessments. There are many challenges in adapting evidence-based methodologies from clinical research to toxicology, among them quality assessment of epidemiological, animal and in vitro toxicological studies, evidence synthesis and integration across different study types (evidence streams), incorporation of expert judgment, certainty assessment and frameworks for bringing the evidence to regulatory decisions. This article looks back at the history of EBT, highlighting the successes and challenges along the way and attempting to map out its future in toxicology and risk assessment.