Report of the Synthesis and Integration of Epidemiological and Toxicological Evidence Subgroup (SETE) of the Committee on Toxicity and the Committee on Carcinogenicity
Abstract:There are a number of guidance documents and frameworks available on the use of epidemiological and toxicological information in chemical risk assessment, however the majority assesses these two evidence streams separately and subsequently bring them together qualitatively, using expert judgement. These frameworks and guidance documents generally provide little information on how toxicological and epidemiological data should be integrated in a transparent manner, giving appropriate weight to both. It was there… Show more
“…Diekmann & Heesterbeek, 2000), and invasive species and entomology (e.g. Cock & Wittenberg, 2001). There is also a very strong focus on the environmental drivers of insect pest and pathogen populations in plant health, which are a major contributing factor to epidemics.…”
Section: Epidemiological Studies In Plantsmentioning
EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases, which may be present in different epidemiological study designs. It then describes key epidemiological concepts relevant for evidence appraisal. This includes brief explanations for measures of association, exposure assessment, statistical inference, systematic error and effect modification. The guidance then describes the concept of external validity and the principles of appraising epidemiological studies. The customisation of the study appraisal process is explained including tailoring of tools for assessing the risk of bias (RoB). Several examples of appraising experimental and observational studies using a RoB tool are annexed to the document to illustrate the application of the approach. The latter part of this guidance focuses on different steps of evidence integration, first within and then across different streams of evidence. With respect to risk characterisation, the guidance considers how evidence from human epidemiological studies can be used in dose–response modelling with several different options being presented. Finally, the guidance addresses the application of uncertainty factors in risk characterisation when using evidence from human epidemiological studies.
“…Diekmann & Heesterbeek, 2000), and invasive species and entomology (e.g. Cock & Wittenberg, 2001). There is also a very strong focus on the environmental drivers of insect pest and pathogen populations in plant health, which are a major contributing factor to epidemics.…”
Section: Epidemiological Studies In Plantsmentioning
EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases, which may be present in different epidemiological study designs. It then describes key epidemiological concepts relevant for evidence appraisal. This includes brief explanations for measures of association, exposure assessment, statistical inference, systematic error and effect modification. The guidance then describes the concept of external validity and the principles of appraising epidemiological studies. The customisation of the study appraisal process is explained including tailoring of tools for assessing the risk of bias (RoB). Several examples of appraising experimental and observational studies using a RoB tool are annexed to the document to illustrate the application of the approach. The latter part of this guidance focuses on different steps of evidence integration, first within and then across different streams of evidence. With respect to risk characterisation, the guidance considers how evidence from human epidemiological studies can be used in dose–response modelling with several different options being presented. Finally, the guidance addresses the application of uncertainty factors in risk characterisation when using evidence from human epidemiological studies.
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