---
title: "Evidence-based toxicology"
chunk: 2/3
source: "https://en.wikipedia.org/wiki/Evidence-based_toxicology"
category: "reference"
tags: "science, encyclopedia"
date_saved: "2026-05-05T04:25:48.329362+00:00"
instance: "kb-cron"
---

== Process and progress ==
The First International Forum Toward Evidence-Based Toxicology was held in 2007. The forum was organized by the European Commission and attended by 170 scientists from more than 25 European, American, and Asian countries.  The goal was to explore the available concepts of EBT, and to launch an initiative to formally implement evidence-based assessment methods in toxicology.
The starting point for the discussions were two research papers suggesting that the tools and concepts established in evidence-based medicine could serve as a prototype of evidence-based decision-making for evaluating toxicological data.  Apparent fundamental differences between medicine and toxicology were carefully considered during these discussions.  Forum participants attempted to bridge the two disciplines in order to make use of the accrued wisdom and apply this approach to toxicology.  (See [1] Archived 2017-07-29 at the Wayback Machine .)
The proceedings of this forum were published as a special issue in Human & Experimental Toxicology.
EBT's proponents include experts in EBM, public health, and toxicology who believe that EBT can help toxicologists to better serve the goals of health protection and safety assurance. They argue that EBT's methodologies for collecting, appraising, and pooling evidence can help ensure that all available information on a given topic is evaluated in a transparent, unbiased, and reproducible manner. They contend that EBT's concept of the systematic review could prove particularly helpful for the standardization and quality assurance of novel methodologies for evaluating toxicity, as well as for their formal validation.  In this regard, EBT may prove particularly useful for assessing the performance of newer non-animal "21st century" toxicology tools.  EBT can also help scientists integrate new toxicological test methods into test strategies being implemented across the globe.
In 2010, a group of EBT supporters joined together to convene a workshop titled "21st Century Validation for 21st Century Tools".  The session on the potential for evidence-based approaches to assess the performance of the new generation of non-animal test methods inspired the formation of the EBTC.  The EBTC was officially launched in the U.S. in 2011 at a Society of Toxicology conference and convened its first workshop in 2012.  The EBTC's EU branch was officially opened during the 2012 Eurotox conference.
In 2014, the EBTC hosted a workshop on "The Emergence of Systematic Review and Related Evidence-based Approaches in Toxicology" with speakers representing US and European organizations that are implementing and promoting the use of systematic reviews for toxicological questions.  The experts noted that the structured approach of systematic reviews increases objectivity and transparency but also made clear that the approach requires a substantial time investment, which is a challenge to its more widespread adoption. Consequently, the participants called for close collaboration of interested organizations, which they determined to be a pre-requisite for the broad and efficient introduction of systematic reviews in toxicology.

== Applications of EBT ==

=== Regulatory decision-making ===
Some scientists and policymakers would like EBT to help them combine information from various sources.  Toxicological evidence can be assigned to evidence streams, sets of studies representing the same type or level of evidence, such as human (observational) studies, animal studies, in vitro or mechanistic studies.  EBT can be applied both within one evidence stream, and it is especially well-suited to be applied across multiple evidence streams.  Regulators often designate one study as "the lead study", then use later studies as additional information.  Many perceive this as unsatisfying, but objective approaches to combine study results are lacking. The EBM concept of the systematic review has promise for this application, and some structured reviews serve as forerunners for this approach.

=== Evaluating effects of environmental exposures ===
The U.S. National Toxicology Program's Office of Health Assessment and Translation (OHAT) has started to use systematic review methodology for the program's evaluations.  The first systematic review was completed in 2016, reviewing the effects of fluoride on learning and memory in animal studies.  OHAT’s approach is tailored to its mandate, but its seems especially appropriate for substances with substantial yet conflicting literature, and hence the need for systematic reviews to sort out somewhat confusing situations.

=== Causation ===
One application of EBT focuses on causation.  It addresses the challenge of tracing a health effect back to a toxicant, such as lung cancer to smoking.  This approach is similar to legal arguments  Some experts warn that this approach could increase the evidence burden for proving causation, and thereby increase the difficulty involved in banning toxic substances.

=== Clinical toxicology ===
Practitioners of clinical toxicology, which is concerned with the treatment of patients known to be exposed to toxic substances, are also beginning to use an EBM-style approach.  Guidance documents based on this approach have already been published

=== 21st century toxicology ===
The National Research Council's (NRC) landmark 2007 publication, "Toxicity Testing in the 21st Century", has also been an impetus for EBT. EBT provides new tools for assessing test method performance.  Also, as the focus of 21st-century toxicology shifts from animal biology to human biology, EBT provides a method for comparatively evaluating the results gleaned from new methods of investigating the effects of chemical exposure.
The Evidence-based Toxicology Collaboration has pioneered a number of projects aimed at applying EBT approaches and systematic reviews to test methods comparison.