The Scientific Liaison Coalition, of which the Teratology Society is a member, will host the following webinars this fall. Registration via the links below is required for each live webinar. The live webinars are open to members of SLC member societies, including the Teratology Society. Afterwards, recordings of the webinars will be placed in the Educational Webinars File Library on BDR Connection.
Theory and Practical Applications of Systematic Review to Support Regulatory Decision-making for Evidence-based Risk Assessment
The use of systematic review (SR) and evidence-based methodologies in toxicology and risk assessment have evolved from theory to practice. This webinar series is going to provide an overview of the history of SR, describe the general principles of SR, challenges encountered in adopting the methodologies from medicine to toxicology, and present case studies of its use in regulatory decision-making in different domains. The presentations will focus on efforts specifically associated with risk-based practices, such as development of health-based benchmarks (e.g., acceptable daily intakes, reference doses, etc.), rather than characterization of potential hazard (e.g., likelihood to be a hazard to humans for a given health outcome). Tools and frameworks initially developed for the field of medicine have been adapted to apply to toxicological research questions, and in many cases, new tools developed. The presentations will describe how the regulatory practitioners have addressed the challenges of toxicological data relative to that of medicine. For example, address challenges in evaluating exposures vs. interventions, multi-endpoint vs. single endpoint outcomes, well-defined diseases or conditions, complex data that is often not in humans (but rather in experimental animal studies or in vitro studies) vs. randomized controlled trials in humans, and evaluation of mixtures vs. pure substances. And beyond evaluation of individual studies and qualitative characterizations of hazard, approaches to integrate data in the context of risk–to be evaluated on a common metric, to develop health based-benchmarks–have been developed and applied. These concepts must be balanced with the rigor of a SR, a component that translates into time and resources. It is anticipated that these series will provide practical information for toxicologists and risk assessors and facilitate an understanding of how systematic review is being utilized in support of risk-based chemical assessments. Notably, speakers will also highlight how SR provides additional rigor and transparency, as well as relevance of the process in decision-making for regulated chemicals.
Introduction to SR and Their Application in Preclinical Research and Chemical Risk Assessment, Tuesday, September 11, 2018, 11:00 AM-12:30 PM ET USA
Chaired by Katya Tsaioun, PhD, Director, Evidence-Based Toxicology Collaboration, Johns Hopkins Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Baltimore, MD. Dr. Tsaioun will introduce the History and Main Principles of Systematic Review. Kristina Thayer, PhD, US Environmental Protection Agency (USEPA), National Center for Environmental Assessment (NCEA) will present on Systematic Review in Support of Chemical Risk Assessment at USEPA. The USEPA NCEA is currently adapting systematic approaches for the identification, evaluation, and integration of toxicological information in chemical risk assessments. This talk will provide an overview of these approaches as summarized in the Integrated Risk Information System (IRIS) Handbook for conducting systematic reviews in support of IRIS assessments, and how multiple evidence streams influence both hazard and dose-response decisions. Updates on the gradual implementation of these methods will be presented and discussed, using examples of improvements in the consistency and transparency of the scientific decisions made, as well as the practicality of utilizing SR methods for evaluating large, complex toxicological databases. Elisa Aiassa, PhD, Scientific Officer, Assessment and Methodological Support Unit/Risk Assessment & Scientific Assistances Department, European Food Safety Authority (EFSA) will present on Systematic Review in Support of Chemical Risk Assessment at EFSA. The EFSA is the keystone of the European Union risk assessment regarding food and feed safety. Within its mandate, EFSA carries out a wide range of scientific assessments (e.g., safety assessments, efficacy assessments, or full risk assessments) dealing with human and animal nutrition, animal health and welfare, plant protection, plant health and the environment. EFSA has implemented a large variety of projects to develop or adapt methods aiming at increasing the methodological rigor, impartiality, and transparency of its scientific outputs. SR is one of these methods, whose applicability, feasibility, and worthiness to the field of food and feed safety has been extensively examined by EFSA and whose implementation in EFSA assessments has considerably increased over the last decade. This talk will provide case examples of SRs utilized to support broad mandated assessments in the area of chemical risk assessment. The focus will be on the advantages, limitations, and challenges of applying SR to this field, as well as on the needs for further methodological developments. Register
Practical Application of SR in the US
Tuesday, November 27, 11:00 AM–12:30 PM ET USA
Chaired by Katya Tsaioun, PhD, Director, Evidence-Based Toxicology Collaboration, Johns Hopkins Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Baltimore. Dr. Tsaioun will introduce the History and Main Principles of Systematic Review. Kim Wever, PhD, Researcher, Radboud University Medical Center, The Netherlands, will present on Tail-ored: Applying the Concept and Methodology of SR and Meta-analysis to Preclinical Animal Studies. SR help clinicians keep abreast of the medical literature by summarizing large bodies of evidence and helping to explain differences among studies on the same question. Used to inform medical decision-making, plan future research agendas, and establish policy, SR methods are ready to be adopted in risk assessment. Dr. Wever will present several case studies on application of the principles of SR to the evaluation of preclinical animal studies conducted by SYRCLE and others. Challenges in conducing SRs in preclinical research will be addressed. Recent solutions to these challenges such as recently opened pre-registration of preclinical protocols, internal validity (risk of bias) tools, external validity (generalizability of results) will be presented. Daniele Wikoff, PhD, ToxStrategies, will present on Practical Examples of the Integration of Systematic Review to Support Development of Health-based Toxicity Values in Chemical Risk Assessments. This presentation brings together the different applications of SR in the context of quantitative risk-based assessments, differentiating how the rigor and conduct of the approach must accommodate concepts beyond identification and characterization of hazard. An overview of common challenges with respect to procedures and tools utilized in the conduct of quantitative evidence-based assessments will be provided. This will include an introduction to challenges associated with the integration of multi-endpoint and multi-stream evidence bases, as well as integration of internal and external validity as they relate to selection of candidate datasets and development of toxicity values (and how such approaches may be refined relative to application of these concepts in qualitative vs. quantitative assessments). Register