Evidence-Based Toxicology, Explained
The foundations of evidence-based methodologies were laid in medicine over the last few decades. The primary tool of evidence-based medicine (EBM) is the systematic review, which includes a variety of steps: framing the question to be addressed and deciding on how relevant studies will be identified and retrieved, which studies will be excluded from the analysis, how the included studies will be appraised for quality/potential for bias, and how the data will be synthesized across studies (e.g., meta-analysis). Such reviews are also characterized by EBM’s hallmark tenets of transparency, objectivity, and consistency.
The EBTC builds upon the outcomes of the First International Forum Toward Evidence-Based Toxicology, held in Cernobbio/Como, Italy on October 15-18, 2007 . Not only did the EBTC conceptually originated there as a new platform for scientists interested in evidence-based toxicology (EBT), but some of the organizers, contributors and participants of the forum are active in the EBTC today.
The EBT forum was organized by the European Commission in close collaboration with scientists active in toxicology, life sciences, biostatistics, modeling and medicine. About 170 scientists from more than 25 European, American and Asian countries followed the organizers’ invitation to discuss the strengths and weaknesses of methodologies currently used in toxicological safety assessment, to explore the available concepts of EBT, and to launch an initiative to formally implement evidence-based assessment methods.
The EBT initiative was motivated by increasing concerns in the scientific community about the limitations of toxicological decision-making. For example, at the time – and continuing to the present – toxicology still largely relies on traditional assessment methodologies that have changed little despite scientific and technological progress. As a consequence, safety assessments that directly impact our health and environment are largely based on tests of unknown relevance and reliability. Effective and relevant safety assessments in toxicology, however, critically depend on progress in basic scientific research and should adapt continuously to advances in knowledge.
In addition, there is also room for improvement in the way in which the results generated by these tools are used for decision making in hazard and risk assessment affecting subsequent risk management. Concerns mainly center on the transparency and consistency of data interpretation and the integration of various data sets. This first forum was organized to try to answer this urgent need for efficient tools enabling us to make use of all information in a structured, reliable and transparent manner.
The starting points for discussions were two suggestions (Guzelian et al., 2005; Hoffmann & Hartung, 2006) that evidence-based medicine and health care (EBM/HC), with its established tools and concepts, might serve as a prototype of evidence-based decision-making and thus help toxicological practice to come to more consistent and transparent decisions based solely on the external scientific evidence available. Apparent fundamental differences between medicine and toxicology were carefully considered during these discussions attempting to bridge both disciplines in order to make use of the valuable experiences of EBM/HC.
The participants of the forum agreed upon ten defining characteristics of EBT:
- promotes the consistent use of transparent and systematic processes to reach robust conclusions and sound judgments
- addresses societal values and expectations and is socially responsible
- displays a willingness to check the assumptions upon which current toxicological practice is based to facilitate continuous improvement
- recognizes the need to provide for the effective training and development of professional toxicologists
- acknowledges a requirement for new and improved tools for critical evaluation and quantitative integration of scientific evidence
- embraces all aspects of toxicological practice, and all types of evidence of which use is made in hazard identification, risk assessment and retrospective analyses of causation
- ensures the generation and use of best scientific evidence
- includes all branches of toxicological science: human health assessment, environmental and ecotoxicology and clinical toxicology
- acknowledges and builds upon the achievements and contributions of Evidence Based Medicine/Evidence Based Health Care
- fosters the integration of expert judgment with best possible external evidence
The proceedings of this forum were published as a special issue (February/March 2009; 28 (2-3)) in Human & Experimental Toxicology and are available online.
 Adapted with permission from “Cernobbio/Como: First international forum toward evidence-based toxicology”, ALTEX (2007), 4: 354. Guzelian, P.S., Victoroff, M.S., Halmes, N.C., Janes, R.C. and Guzelian, C.P. (2005). Evidence-based toxicology: a comprehensive framework for causation. Human and Experimental Toxicology 24, 161-201. Hoffmann, S. and Hartung T. (2006). Toward an evidence-based toxicology. Human and Experimental Toxicology 25, 497-513.