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The discipline of '''evidence-based toxicology''' ('''EBT''') strives to transparently, consistently, and objectively assess available scientific evidence in order to answer questions in [[toxicology]],<ref name=hoff06>{{cite journal|last=Hoffmann|first=S.|author2=Hartung, T|title=Toward an evidence-based toxicology|journal=Hum Exp Toxicol|year=2006|volume=25|issue=9|pages=497–513|doi=10.1191/0960327106het648oa|pmid=17017003|s2cid=42202416}}</ref> the study of the adverse effects of chemical, physical, or biological agents on living organisms and the environment, including the prevention and amelioration of such effects.<ref name=sot>{{cite web|title=How do you define toxicology?|url=http://www.toxicology.org/AI/PUB/si05/Si05_Define.asp|publisher=Society of Toxicology|access-date=2017-06-17|archive-url=https://web.archive.org/web/20130605220710/http://www.toxicology.org/AI/PUB/si05/Si05_Define.asp|archive-date=2013-06-05|url-status=dead}}</ref> EBT has the potential to address concerns in the toxicological community about the limitations of current approaches to assessing the state of the science.<ref name=stephens13>{{cite journal|last=Stephens|first=M.|author2=Andersen, M. |author3=Becker, R.A. |author4=Betts, K. |title=Evidence-based toxicology for the 21st century: Opportunities and challenges|journal=ALTEX|year=2013|volume=30|issue=1|pages=74–104|doi=10.14573/altex.2013.1.074|pmid=23338808|display-authors=etal|doi-access=free}}</ref><ref name=Mandrioli>{{cite journal|last=Mandrioli|first=D.|author2=Silbergeld, E. |title=Evidence from toxicology: the most essential science for the prevention. |journal=Environ Health Perspect|year=2016|volume=124|issue=1|pages=6–11|doi=10.1289/ehp.1509880|pmid=26091173|pmc=4710610}}</ref> These include concerns related to transparency in decision making, synthesis of different types of evidence, and the assessment of bias and credibility.<ref>{{cite journal|last=Schreider|first=J.|author2=Barrow, C. |author3=Birchfield, N. |title=Enhancing the credibility of decisions based on scientific conclusions: transparency is imperative|journal=Toxicol Sci|year=2010|volume=116|issue=1|pages=5–7|doi=10.1093/toxsci/kfq102|pmid=20363830|display-authors=etal|doi-access=free}}</ref><ref name=Adami>{{cite journal|last=Adami|first=H.O.|author2=Berry, S.C. |author3=Breckenridge, C.B. |author4=Smith, L.L. |title=Toxicology and epidemiology: improving the science with a framework for combining toxicological and epidemiological evidence to establish causal inference|journal=Toxicol Sci|year=2011|volume=122|issue=2|pages=223–234|doi=10.1093/toxsci/kfr113|pmid=21561883|display-authors=etal|pmc=3155086}}</ref><ref name=conrad>{{cite journal|last=Conrad|first=J.W.|author2=Becker, R.A.|title=Enhancing credibility of chemical safety studies: an emerging consensus on key assessment criteria|journal=Environ Health Perspect|year=2011|volume=119|issue=6|pages=757–764|doi=10.1289/ehp.1002737|pmid=21163723|pmc=3114808}}</ref> Evidence-based toxicology has its roots in the larger movement towards [[evidence-based practices]].
By analogy to [[evidence-based medicine]] (EBM),<ref name=eddy>{{cite journal|last=Eddy|first=D.M.|title=Evidence-Based Medicine: A Unified Approach|journal=Health Aff|year=2005|volume=24|issue=1|pages=9–17|doi=10.1377/hlthaff.24.1.9|pmid=15647211|doi-access=free}}</ref> the umbrella term evidence-based toxicology (EBT) has been coined to group all approaches intended to better implement the above-mentioned evidence-based principles in toxicology in general and in toxicological decision-making in particular. Besides systematic reviews, the core evidence-based tool, such approaches include ''inter alia'' the establishment and universal use of a common ontology, justified design and rigorous conduct of studies, consistently structured and detailed reporting of experimental evidence, probabilistic uncertainty and risk assessment, and the development of synthesis methodology to integrate evidence from diverse evidence streams, e.g. from human observational studies, animal studies, in vitro studies and in silico modeling. A main initial impetus for translating evidence-based approaches to toxicology was the need to improve the performance assessment of toxicological test methods.<ref name=hoff05>{{cite journal|last=Hoffmann|first=S.|author2=Hartung, T|title=Diagnosis: toxic! Trying to apply approaches of clinical diagnostics and prevalence in toxicology considerations|journal=Toxicol Sci|year=2005|volume=85|issue=1|pages=422–428|doi=10.1093/toxsci/kfi099|pmid=15689419|citeseerx=10.1.1.546.8341}}</ref> 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, capitalizing on enhanced scientific understanding through modern biochemistry and molecular biology.<ref name=nrc>{{cite book|last=National Research Council|title=Toxicity Testing in the 21st Century: A Vision and a Strategy|year=2007|publisher=The National Academies Press|location=Washington, DC}}</ref>
A key tool in evidence-based medicine that holds promise for EBT is the systematic review. Historically, authors of reviews assessing the results of toxicological studies on a particular topic have searched, selected, and weighed the scientific evidence in a non-systematic and non-transparent way. Due to their narrative nature, these reviews tend to be subjective, potentially biased, and not readily reproducible.<ref name=hoff06 /> Two examples highlighting these deficiencies are the risk assessments of trichloroethylene and bisphenol A (BPA). Twenty-seven different risk assessments of the evidence that trichloroethylene causes cancer have come to substantially different conclusions.<ref name=ruden03>{{cite journal|last=Rudén|first=C.|title=The use and evaluation of primary data in 29 trichloroethylene carcinogen risk assessments|journal=Regul Toxicol Pharmacol|year=2001|volume=34|issue=1|pages=3–16|doi=10.1006/rtph.2001.1482|pmid=11502152}}</ref> Assessments of BPA range from low risk of harm to the public to potential risks (for some populations), leading to different political decisions.<ref name=whaley>{{cite journal|last=Whaley|first=P.|author2=Halsall, C. |author3=Ågerstrand, R.A. |author4=Aiassa, E. |title=Implementing systematic review techniques in chemical risk assessment: Challenges, opportunities and recommendations.|journal=Environ Int|year=2016|volume=92-93|pages=556–64|doi=10.1016/j.envint.2015.11.002|pmid=26687863|pmc=4881816|display-authors=etal}}</ref> Systematic reviews can help reducing such divergent views.<ref name=stephens13 /> In contrast with narrative reviews, they reflect a highly structured approach to reviewing and synthesizing the scientific literature while limiting bias.<ref name=stephens13 /> The steps to carrying out a systematic review include framing the question to be addressed; identifying and retrieving relevant studies; determining if any retrieved studies should be excluded from the analysis; and appraising the included studies in terms of their methodological quality and risk of bias. Ultimately the data should be synthesized across studies, if possible by a meta-analysis. A protocol of how the review will be conducted is prepared ahead of time and ideally should be registered and/or published.▼
▲A key tool in evidence-based medicine that holds promise for EBT is the systematic review. Historically, authors of reviews assessing the results of toxicological studies on a particular topic have searched, selected, and weighed the scientific evidence in a non-systematic and non-transparent way. Due to their narrative nature, these reviews tend to be subjective, potentially biased, and not readily reproducible.<ref name=hoff06 /> Two examples highlighting these deficiencies are the risk assessments of trichloroethylene and bisphenol A (BPA). Twenty-seven different risk assessments of the evidence that trichloroethylene causes cancer have come to substantially different conclusions.<ref name=ruden03>{{cite journal|last=Rudén|first=C.|title=The use and evaluation of primary data in 29 trichloroethylene carcinogen risk assessments|journal=Regul Toxicol Pharmacol|year=2001|volume=34|issue=1|pages=3–16|doi=10.1006/rtph.2001.1482|pmid=11502152}}</ref> Assessments of BPA range from low risk of harm to the public to potential risks (for some populations), leading to different political decisions.<ref name=whaley>{{cite journal|last=Whaley|first=P.|author2=Halsall, C. |author3=Ågerstrand, R.A. |author4=Aiassa, E. |title=Implementing systematic review techniques in chemical risk assessment: Challenges, opportunities and recommendations.|journal=Environ Int|year=2016|volume=92-93|pages=
Scientists have made progress in their efforts to apply the systematic review framework to evaluating the evidence for associations between environmental toxicants and human health risks. To date, researchers have shown that important elements of the framework established in evidence-based medicine can be adapted to toxicology with little change, and some studies have been attempted.<ref name=Navas-Acien05>{{cite journal|last=Navas-Acien|first=A.|author2=Sharrett, A. R. |author3=Silbergeld, E. K. |title=Arsenic exposure and cardiovascular disease: a systematic review of the epidemiologic evidence|journal=Am J Epidemiol|year=2005|volume=162|issue=11|pages=1037–1049|doi=10.1093/aje/kwi330|pmid=16269585|display-authors=etal|doi-access=free}}</ref><ref name=krauth>{{cite journal|last=Krauth|first=D.|author2=Woodruff, T.J. |author3=Bero, L. |title=Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review|journal=Environ Health Perspect|year=2013|volume=121|issue=9|pages=985–992|doi=10.1289/ehp.1206389|pmid=23771496|pmc=3764080|display-authors=etal}}</ref><ref name=silberalt13>{{cite journal|last=Silbergeld|first=E.|author2=Scherer, R.W.|title=Evidence-based toxicology: Strait is the gate, but the road is worth taking|journal=ALTEX|year=2013|volume=30|issue=1|pages=67–73|doi=10.14573/altex.2013.1.067|pmid=23338807|doi-access=free}}</ref> Researchers using the systematic review methodology to address toxicological concerns include a group of scientists from government, industry, and academia in North America and the European Union (EU) who have joined together to promote evidence-based approaches to toxicology through the nonprofit [[Evidence-based Toxicology Collaboration]] (EBTC). The EBTC brings together the international toxicology community to develop EBT methodology and facilitate the use of EBT to inform regulatory, environmental and public health.<ref name=stephens13 /><ref name=Stephens16>{{cite journal|last=Stephens|first=M.|author2=Betts, K. |author3=Beck, N.B. |author4=Cogliano, V. |title=The emergence of systematic review in toxicology|journal=Toxicol Sci|year=2016|volume=152|issue=1|pages=10–16|doi=10.1093/toxsci/kfw059|pmid=27208075|display-authors=etal|pmc=4922539}}</ref><ref name=Samuel>{{cite journal|last=Samuel|first=G.O.|author2=Hoffmann, S. |author3=Wright, R.A. |author4=Lalu, M.M. |title=Guidance on assessing the methodological and reporting quality of toxicologically relevant studies|journal=Environ Int|year=2016|volume=92-93|pages=630–46|doi=10.1016/j.envint.2016.03.010|pmid=27039952|display-authors=etal|doi-access=free}}</ref>▼
▲Scientists have made progress in their efforts to apply the systematic review framework to evaluating the evidence for associations between environmental toxicants and human health risks. To date, researchers have shown that important elements of the framework established in evidence-based medicine can be adapted to toxicology with little change, and some studies have been attempted.<ref name=Navas-Acien05>{{cite journal|last=Navas-Acien|first=A.|author2=Sharrett, A.
== Background ==
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EBM/HC supporters stress that while evidence always has been important to the practice of medicine, EBM/HC provides an enhanced approach of identifying, assessing, and summarizing evidence. EBT's supporters make a similar argument.<ref name="stephens13" />
The idea of translating evidence-based approaches from medicine to toxicology has been percolating for two decades, with proponents in both medicine and toxicology.<ref>{{cite journal|last=Buckley|first=N.A.|author2=Smith, A.
== Process and progress ==
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The First International Forum Toward Evidence-Based Toxicology was held in 2007.<ref name=Hoffman07>{{cite journal|last=Hoffman|first=S.|author2=Griesinger, C. |author3=Coecke, S. |author4=Kinser, A. |title=1st International Forum Towards Evidence-Based Toxicology.|journal=ALTEX|year=2007|volume=24|pages=354–355|display-authors=etal}}</ref> 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.<ref name=hoff06 /><ref name=hoff05 /> 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 [http://www.ebtox.org/resources/evidence-based-toxicology-explained/] {{Webarchive|url=https://web.archive.org/web/20170729132040/http://www.ebtox.org/resources/evidence-based-toxicology-explained/ |date=2017-07-29 }} .)
The proceedings of this forum were published as a special issue in ''Human & Experimental Toxicology''.<ref>{{cite journal|title=Proceedings of the 1st International Forum Towards Evidence-Based Toxicology|journal=Hum Exp Toxicol|year=2009|volume=28|issue=2–3|pages=71–163|doi=10.1177/0960327109102802|pmid=19713364|last1=Guzelian|first1=P.
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.<ref name=silberalt13 /><ref name="Stephens16" /> 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".<ref>{{cite journal|last=Rudacille|first=D.|title=Summary of the July 2010 Workshop, "21st Century Validation Strategies for 21st Century Tools"|journal=ALTEX|year=2010|volume=27|issue=2|pages=279–284|doi=10.14573/altex.2010.4.279|doi-access=free}}</ref> 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.
In 2014, the EBTC hosted a workshop on
== Applications of EBT ==
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=== 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.<ref>{{cite journal|last=Navas-Ancien|first=A.|author2=Guallar, E. |author3=Silbergeld, E.
<ref>{{cite journal|title=Scientific Opinion on the risk assessment peri- and post-menopausal women taking food supplements containing isoflavones.|journal=EFSA Journal|year=2015|volume=13|issue=10|pages=
=== Evaluating effects of environmental exposures ===
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=== 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.<ref>{{cite journal|last=Dargan|first=P.I.|author2=Wallace, C.
=== 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.<ref name="hart09">{{cite journal|last=Hartung|first=T.|year=2009|title=Food for thought ... on evidence-based toxicology|journal=ALTEX|volume=26|issue=2|pages=75–82|doi=10.14573/altex.2009.2.75|pmid=19565165|doi-access=free}}</ref>
The [[Evidence-based Toxicology Collaboration]] has pioneered a number of projects aimed at applying EBT approaches and systematic reviews to test methods comparison.<ref>{{Cite journal|last1=Stephens|first1=Martin L.|last2=Akgün-Ölmez|first2=Sevcan Gül|last3=Hoffmann|first3=Sebastian|last4=de Vries|first4=Rob|last5=Flick|first5=Burkhard|last6=Hartung|first6=Thomas|last7=Lalu|first7=Manoj|last8=Maertens|first8=Alexandra|last9=Witters|first9=Hilda|last10=Wright|first10=Robert|last11=Tsaioun|first11=Katya|date=2018-06-13|title=Adaptation of the Systematic Review Framework to the Assessment of Toxicological Test Methods: Challenges and Lessons Learned with the Zebrafish Embryotoxicity Test|journal=Toxicological Sciences |volume=171|pages=56–68|doi=10.1093/toxsci/kfz128|issn=1096-0929|pmc=6736188|pmid=31192353}}</ref><ref>{{Cite journal|last1=Dirven|first1=Hubert|last2=Vist|first2=Gunn E.|last3=Bandhakavi|first3=Sricharan|last4=Mehta|first4=Jyotsna|last5=Fitch|first5=Seneca E.|last6=Pound|first6=Pandora|last7=Ram|first7=Rebecca|last8=Kincaid|first8=Breanne|last9=Leenaars|first9=Cathalijn H.
== Limitations and challenges ==
The specific differences between toxicology and medicine/health care cause challenges for implementing EBT.<ref name=silberalt13 /> Evidence-based methodology of clinical research has been focused on a single type of study—randomized, controlled clinical trials, which are a direct measure of the effectiveness of the health care intervention under scrutiny. In contrast, toxicology employs a variety of different kinds of studies in three distinct evidence streams: human (observational) studies, animal studies, and non-animal studies. Because human evidence is frequently lacking
== See also ==
* [[Evidence-based medicine]]
* [[Evidence-based
== References ==
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