About EBT
Why do we need evidence-based toxicology (EBT)?
Toxicology and the delivery of effective safety assessment critically relies on concepts and understanding generated by basic scientific research and must therefore adapt constantly to advances in knowledge.
However, particularly from the perspective of regulatory toxicology, some of the assessment paradigms and methodologies were established decades ago and have changed little in response to scientific progress. At the same time, changes in our understanding of human disease, changes in the types of product now requiring safety assessment, and changes in the legislative landscape and public expectations pose significant challenges for industry, academia and regulators alike.
It is necessary to challenge the status quo and ensure that as a matter of course best scientific practice and technical sophistication is reflected in safety assessment practices such that current and future challenges can be met.
It is important therefore to ensure that structures are available that will encourage, facilitate and support a process of critical appraisal and renewal of the toxicological repertoire available for safety assessment. Part of this process is to embrace “evidence-based toxicology” such that the best possible scientific evidence is applied to judge product safety and likely risks to human health.
Evidence-based medicine as a role model?
Over the last two decades clinical medicine has developed new approaches that focus strongly on scientific evidence. “Evidence-based medicine” seeks to ensure that any decision relevant for the health of patients is based on the best evidence available. A suite of assessment methods and decision-aiding tools, as well as structures for their implementation in the decision-making process, have been developed. Collectively these have served to strengthen significantly the scientific basis of medicine.
Against this background it has been suggested recently (Guzelian et al., 2005; Hoffmann & Hartung, 2006) that evidence-based medicine with its established tools and concepts might serve as a template for toxicology, helping to ensure that toxicological practice is fit for purpose, embraces the latest scientific and technological advances and is equipped to meet its challenges.
