The nonprofit Evidence-based Toxicology Collaboration (EBTC) comprises a group of scientists and experts with ties to governmental agencies, chemical and pharmaceutical companies, and academia that have banded together to promote the use of what are known as “evidence-based approaches” in toxicology. The emerging discipline of evidence-based toxicology (EBT) is a process for transparently, consistently, and objectively assessing available scientific evidence in order to answer questions in toxicology, the study of the adverse effects of chemical, physical, or biological agents on living organisms and the ecosystem, including the prevention and amelioration of such adverse effects. EBT has the potential to address concerns in the toxicological community about the limitations of current approaches to assessing the state of the science. These include concerns related to transparency in decision making, synthesis of different types of evidence, and the assessment of bias and credibility.
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The evidence-based methods and approaches now being proposed for toxicology are widely used in medicine, which is the basis for their nomenclature. The need to improve how the performance of toxicological test methods is assessed was the main impetus for translating these tools to toxicology. The U.S. National Research Council (NRC) concurs that new means of assessment are needed to keep pace with recent advances in the development of toxicological test methods. These new test methods capitalize on the recent advances in biochemistry and molecular biology that have enhanced scientists’ understanding of the nature and mechanisms underlying how chemicals cause adverse effects, and the tests have the potential to be much quicker and less expensive than the tests traditionally used to evaluate toxicity.
Goals and benefits
The EBTC’s overall goals are to improve toxicological decision-making, facilitate the modernization of the toxicological toolbox, and reinvigorate the safety sciences. The group is promoting “the use of evidence-based approaches to strengthen decision-making in safety sciences… guided by themes of transparency, objectivity, and consistency.” The organization’s members envision that as these efforts succeed, all interested parties—including stakeholders in government, industry, academia, the nonprofit sector, and the general public – will have greater confidence and trust in the process by which scientific evidence is assessed when addressing questions related to the safety of chemicals to human health and the environment. All individuals affiliated with the organization are volunteers, except those serving in the organisation’s secretariat, which is sponsored by the Johns Hopkins University’s Center for Alternatives to Animal Testing (CAAT).
The EBTC’s members stress that evidence has always been used in toxicology. The evidence-based approach that the collaboration is championing have been used in medicine for decades. Evidence-based medicine (EBM) is a widely respected discipline and it has strengthened the scientific foundation of decision-making in clinical medicine by providing a structured way of assessing the evidence bearing on healthcare questions. The EBTC’s name acknowledges both EBM and the Cochrane Collaboration, an international network of more than 31,000 dedicated people from over 100 countries and a well-known proponent of evidence-based health care (EBHC).
The EBTC foresees that the evidence-based approach will provide similar benefits to toxicology, especially at a time when remarkable advances in biochemistry and molecular biology are enhancing scientists’ ability to understand the nature and mechanisms of the adverse effects that can be caused by chemicals. Eventually, the EBTC will evolve into an umbrella organization facilitating the application of evidence-based approaches to toxicology.
Origins
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., The forum was motivated by increasing concerns in the scientific community about the limitations of toxicological decision-making.
This initial EBT forum was organized by the European Commission in close collaboration with scientists active in toxicology, life sciences, biostatistics, modeling, and medicine. They discussed 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. Some of the organizers, contributors, and participants of the forum are active in the EBTC today.
EBT was next a major topic of discussion at a 2010 workshop held at Johns Hopkins University on 21st century validation for 21st century methods. The enthusiasm for EBT at this workshop inspired the EBTC’s formation. The North American EBTC branch held its inaugural conference on March 10, 2011 as a satellite to the 50th annual Society of Toxicology meeting in Washington DC. At the workshop, speakers presented the concept of EBT as it pertains to decision-making about the utility of new toxicity tests and their implementation into the risk assessment process. The EBTC’s European Union (EU) branch was officially opened during the 2012 Eurotox conference. In January, 2012, the EBTC held a workshop on “Evidence-based Toxicology for the 21st Century: Opportunities and Challenges” in Research Triangle Park, North Carolina. The presentations largely reflected two EBTC priorities: to apply evidence-based methods to assessing the performance of emerging pathway-based testing methods consistent with the 2007 NRC report, as well as to adopt a governance structure and work processes to move that effort forward. The workshop served to clarify evidence-based approaches and to provide food for thought on substantive and administrative activities for the EBTC.
Tools
The EBTC is translating the tools used in evidence-based medicine (EBM) to toxicology, as well as developing new approaches to respond to the challenges presented by the discipline of toxicology. The primary tool of 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; determining which studies will be excluded from the analysis, and 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. Scientists have made progress in their efforts to apply systematic reviews to evaluate the evidence for associations between environmental toxicants and human health risks. To date, researchers have shown that important elements of the systematic review methodology established in evidence-based medicine can be adopted into EBT, and a limited number of such studies have been attempted. EBTC scientists are promoting and conducting systematic reviews of toxicological test methods., This is just one of the avenues that the EBTC’s members are researching to help toxicologists improve health protection and safety assurance.,
Organization
The EBTC has closely coordinated steering committees in North America and Europe with members with ties to government agencies, academia, and industry. The organization also has working groups charged with producing guidance documents tailored to toxicology on conducting systematic reviews and their components, including data appraisal and data synthesis. Working groups are also focused on the application of evidence-based tools to various toxicological practices, such as assessing the hazards and risks of exposure to individual chemicals and assessing the performance of toxicological test methods.
Scientists affiliated with the EBTC are conducting pilot studies to demonstrate the value of evidence-based approaches for helping researchers evaluate new laboratory tools and tests for assessing chemical toxicity.
The EBTC’s website, http://www.ebtox.com/, lists the organization’s Steering Committee members and sponsors.