Applying evidence-based methods to the development and use of adverse outcome pathways

Rob B. M. de Vries; Michelle Angrish; Patience Browne; Jan Brozek; Andrew A. Rooney; Daniele S. Wikoff; Paul Whaley; Stephen W. Edwards; Rebecca L. Morgan; Ingrid L. Druwe; Sebastian Hoffmann; Thomas Hartung; Kristina Thayer; Marc T. Avey; Brandiese E. J. Beverly; Maicon Falavigna; Catherine Gibbons; Katy Goyak; Andrew Kraft; Fernando Nampo; Amir Qaseem; Meg Sears; Jasvinder A. Singh; Catherine Willett; Erin Y.  Yost; Holger Schünemann; Katya Tsaioun

doi:10.14573/altex.2101211

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Published: Apr 20, 2021

DOI: https://doi.org/10.14573/altex.2101211

Keywords:

adverse outcome pathway, systematic review, evidence-based, risk assessment, non-animal method

Rob B. M. de Vries, Michelle Angrish, Patience Browne, Jan Brozek, Andrew A. Rooney, Daniele S. Wikoff, Paul Whaley, Stephen W. Edwards, Rebecca L. Morgan, Ingrid L. Druwe, Sebastian Hoffmann, Thomas Hartung, Kristina Thayer, Marc T. Avey, Brandiese E. J. Beverly, Maicon Falavigna, Catherine Gibbons, Katy Goyak, Andrew Kraft, Fernando Nampo, Amir Qaseem, Meg Sears, Jasvinder A. Singh, Catherine Willett, Erin Y. Yost, Holger Schünemann, Katya Tsaioun
[show affiliations]

Rob B. M. de Vries

Evidence-Based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; SYRCLE, Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands

Michelle Angrish

United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessments, Research Triangle Park, NC, USA

Patience Browne

Test Guidelines Programme, Environmental Directorate, OECD, Paris, France

Jan Brozek

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada

Andrew A. Rooney

Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA

Daniele S. Wikoff

ToxStrategies, Asheville, NC, USA

Paul Whaley

Evidence-Based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Lancaster Environment Centre, Lancaster University, Lancaster, UK

Stephen W. Edwards

RTI International, Research Triangle Park, NC, USA

Rebecca L. Morgan

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada

Ingrid L. Druwe

United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessments, Research Triangle Park, NC, USA

Sebastian Hoffmann

Evidence-Based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; seh consulting + service, Paderborn, Germany

Thomas Hartung

Center for Alternatives to Animal Testing (CAAT) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

https://orcid.org/0000-0003-1359-7689

Kristina Thayer

United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessments, Research Triangle Park, NC, USA

Marc T. Avey

ICF, Durham, NC, USA

Brandiese E. J. Beverly

Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA

Maicon Falavigna

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; National Institute for Health Technology Assessment, UFRGS, Porto Alegre, Brazil

Catherine Gibbons

United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessments, Research Triangle Park, NC, USA

Katy Goyak

ExxonMobil Biomedical Sciences Inc., Annandale, NJ, USA

Andrew Kraft

United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessments, Research Triangle Park, NC, USA

Fernando Nampo

Evidence-Based Public Health Research Group, Latin-American Institute of Life and Nature Sciences, Federal University of Latin-American Integration, Foz do Iguassu, Parana, Brazil

Amir Qaseem

Center for Evidence Reviews, The American College of Physicians, Philadelphia, PA, USA

Meg Sears

Canadian Environmental Health Information Infrastructure, Ottawa Hospital Research Institute, Ottawa, ON, Canada

Jasvinder A. Singh

Medicine Service, VA Medical Center, Birmingham, AL, USA; Department of Medicine at the School of Medicine, University of Alabama at Birmingham (UAB), Birmingham, AL, USA; Department of Epidemiology at the UAB School of Public Health, Birmingham, AL, USA

Catherine Willett

Humane Society International, Washington, DC, USA

Erin Y. Yost

United States Environmental Protection Agency, Office of Research and Development, Center for Public Health and Environmental Assessments, Research Triangle Park, NC, USA

Holger Schünemann

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; McMaster GRADE Centre and Michael G DeGroote Cochrane Canada Centre, McMaster University, Hamilton, ON, Canada

Katya Tsaioun

Evidence-Based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

[hide affiliations]

Abstract

The workshop “Application of evidence-based methods to construct mechanistic frameworks for the development and use of non-animal toxicity tests” was organized by the Evidence-based Toxicology Collaboration and hosted by the Grading of Recommendations Assessment, Development and Evaluation Working Group on June 12, 2019. The purpose of the workshop was to bring together international regulatory bodies, risk assessors, academic scientists, and industry to explore how systematic review methods and the adverse outcome pathway framework could be combined to develop and use mechanistic test methods for predicting the toxicity of chemical substances in an evidence-based manner. The meeting covered the history of biological frameworks, the way adverse outcome pathways are currently developed, the basic principles of systematic methodology, including systematic reviews and evidence maps, and assessment of certainty in models, and adverse outcome pathways in particular. Specific topics were discussed via case studies in small break-out groups. The group concluded that adverse outcome pathways provide an important framework to support mechanism-based assessment in environmental health. The process of their development has a few challenges that could be addressed with systematic methods and automation tools. Addressing these challenges will increase the transparency of the evidence behind adverse outcome pathways and the consistency with which they are defined; this in turn will increase their value for supporting public health decisions. It was suggested to explore the details of applying systematic methods to adverse outcome pathway development in a series of case studies and workshops.

How to Cite

de Vries, R. B. M., Angrish, M., Browne, P., Brozek, J., Rooney, A. A., Wikoff, D. S., Whaley, P., Edwards, S. W., Morgan, R. L., Druwe, I. L., Hoffmann, S., Hartung, T., Thayer, K., Avey, M. T., Beverly, B. E. J., Falavigna, M., Gibbons, C., Goyak, K., Kraft, A., Nampo, F., Qaseem, A., Sears, M., Singh, J. A., Willett, C., Yost, E. Y. ., Schünemann, H. and Tsaioun, K. (2021) “Applying evidence-based methods to the development and use of adverse outcome pathways”, ALTEX - Alternatives to animal experimentation, 38(2), pp. 336–347. doi: 10.14573/altex.2101211.

Issue

Vol. 38 No. 2 (2021)

Section

Meeting Reports

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