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{{Short description|Evaluation based on data collection and analysis}}
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|pages=497–513|doi=10.1191/0960327106het648oa}}</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|accessdate=2017-06-17}}</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|display-authors=etal}}</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|pages=6–11|doi=10.1289/ehp.1509880}}</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|pages=5–7|doi=10.1093/toxsci/kfq102|display-authors=etal}}</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|pages=223–234.|doi=10.1093/toxsci/kfr113|display-authors=etal}}</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|pages=757–764|doi=10.1289/ehp.1002737}}</ref>▼
{{Evidence-based practices}}
▲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|
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!
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|pages=3–16|doi=10.1006/rtph.2001.1482}}</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|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|pages=1037–1049|doi=10.1093/aje/kwi330|display-authors=etal}}</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|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}}</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|display-authors=etal}}</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|display-authors=etal}}</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 ==
Evidence-based approaches were first conceived as a means of anchoring policy decisions, not to current practices or the beliefs of experts, but to experimental evidence.<ref name=Eddy>{{cite journal|last=Eddy|first=D.M.|title=Practice Policies:
EBM/HC involves the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients taking patients' preferences into account.<ref name=Sackett>{{cite journal|last=Sackett|first=D.L.|author2=Rosenberg, W.M. |author3=Gray, J.A. |author4=Haynes, R.B. |title=Evidence based medicine: what it is and what it isn't|journal=
EBM/HC supporters stress that while evidence always has been important to the practice of medicine, EBM/HC provides
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 ==
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=
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
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=
In 2010, a group of EBT supporters joined together to convene a workshop titled
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
<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 ===
The U.S. National Toxicology Program's Office of Health Assessment and Translation (OHAT) has started to use
=== Causation ===
One application of EBT focuses on causation.<ref name=guzelian /> 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<ref>{{cite journal|last=Rodricks|first=J.V.|title=Evaluating disease causation in humans exposed to toxic substances|journal=J Law Policy|year=2006|volume=41|pages=62}}</ref> Some experts warn that this approach could increase the evidence burden for proving causation, and thereby increase the difficulty involved in banning toxic substances.<ref>{{cite journal|last=Rudén|first=C.|author2=Hansson, S. O.|title=Evidence-based toxicology: "sound science" in new disguise|journal=Int J Occup Environ Health|year=2008|volume=14|issue=4|pages=299–306|doi=10.1179/oeh.2008.14.4.299|pmid=19043917|s2cid=24010570}}</ref>
=== 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
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.C.|last10=Chen|first10=Minjun|last11=Wright|first11=Robert A.|date=2021-03-18|title=Performance of preclinical models in predicting drug-induced liver injury in humans: a systematic review|journal=Scientific Reports|volume=11|issue=1|pages=6403|doi=10.1038/s41598-021-85708-2|issn=2045-2322|pmc=7973584|pmid=33737635}}</ref>
== Limitations and challenges ==
The specific differences between toxicology and medicine
== See also ==
* [[Evidence-based medicine]]
* [[Evidence-based
== References ==
{{reflist}}
{{Evidence-based practice}}
[[Category:Evidence-based medicine]]
[[Category:Toxicology]]
[[Category:Evidence-based practices]]
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