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Papers by Hilko van der Voet

Research paper thumbnail of G-TwYST harmonisation of statistical methods for use of omics data in food safety assessment

Research paper thumbnail of A probabilistic approach for risk-benefit assessment of food substitutions: A case study on substituting meat by fish

Food and Chemical Toxicology, Apr 1, 2019

Research paper thumbnail of G-TwYST study A combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603 : statistical report, 12 months data

Research paper thumbnail of Comparative safety assessment of genetically modified crops: focus on equivalence with reference varieties could contribute to more efficient and effective field trials

Transgenic Research

The initial compositional analysis of plants plays an important role within the internationally h... more The initial compositional analysis of plants plays an important role within the internationally harmonized comparative safety assessment approach for genetically modified plants. Current EFSA guidance prescribes two types of comparison, namely difference tests with regard to a conventional comparator or control, and equivalence tests with regard to a collection of commercial reference varieties. The experience gained so far shows that most of the statistically significant differences between the test and control can be discounted based on the fact that they are still within equivalence limits of reference varieties with a presumed history of safe use. Inclusion of a test variety and reference varieties into field trial design, and of the statistical equivalence test would already suffice for the purpose of finding relevant parameters that warrant further assessment, hence both the inclusion of a conventional counterpart and the performance of difference testing can be omitted. This ...

Research paper thumbnail of FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovation

Frontiers in Toxicology

The environmental impact on health is an inevitable by-product of human activity. Environmental h... more The environmental impact on health is an inevitable by-product of human activity. Environmental health sciences is a multidisciplinary field addressing complex issues on how people are exposed to hazardous chemicals that can potentially affect adversely the health of present and future generations. Exposure sciences and environmental epidemiology are becoming increasingly data-driven and their efficiency and effectiveness can significantly improve by implementing the FAIR (findable, accessible, interoperable, reusable) principles for scientific data management and stewardship. This will enable data integration, interoperability and (re)use while also facilitating the use of new and powerful analytical tools such as artificial intelligence and machine learning in the benefit of public health policy, and research, development and innovation (RDI). Early research planning is critical to ensuring data is FAIR at the outset. This entails a well-informed and planned strategy concerning th...

Research paper thumbnail of A human biomonitoring (HBM) Global Registry Framework: Further advancement of HBM research following the FAIR principles

International Journal of Hygiene and Environmental Health, 2021

Research paper thumbnail of Equivalence Testing Approaches in Genetically Modified Organism Risk Assessment

Journal of Agricultural and Food Chemistry, 2019

Research paper thumbnail of Statement on advancing the assessment of chemical mixtures and their risks for human health and the environment

Environment International, 2020

Research paper thumbnail of Equivalence limit scaled differences for untargeted safety assessments: Comparative analyses to guard against unintended effects on the environment or human health of genetically modified maize

Food and Chemical Toxicology, 2019

Research paper thumbnail of Equivalence analysis to support environmental safety assessment: Using nontarget organism count data from field trials with cisgenically modified potato

Ecology and Evolution, 2019

Research paper thumbnail of Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats

Archives of Toxicology, 2019

Research paper thumbnail of G-TwYST study A combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603 : statistical report, 6 months data

Research paper thumbnail of G-TwYST study C a 90-day toxicity study in rats fed GM maize NK603 : statistical report

Research paper thumbnail of Variability of control data and relevance of observed group differences in five oral toxicity studies with genetically modified maize MON810 in rats

Archives of toxicology, Jan 11, 2016

The data of four 90-day feeding trials and a 1-year feeding trial with the genetically modified (... more The data of four 90-day feeding trials and a 1-year feeding trial with the genetically modified (GM) maize MON810 in Wistar Han RCC rats performed in the frame of EU-funded project GRACE were analysed. Firstly, the data obtained from the groups having been fed the non-GM maize diets were combined to establish a historical control data set for Wistar Han RCC rats at the animal housing facility (Slovak Medical University, Bratislava, Slovakia). The variability of all parameters is described, and the reference values and ranges have been derived. Secondly, the consistency of statistically significant differences found in the five studies was analysed. In order to do so, the body weight development, organ weight, haematology and clinical biochemistry data were compared between the studies. Based on the historical control data, equivalence ranges for these parameters were defined, and the values measured in the GM maize-fed groups were compared with these equivalence ranges. Thirdly, the...

Research paper thumbnail of Proposed criteria for the evaluation of the scientific quality of mandatory rat and mouse feeding trials with whole food/feed derived from genetically modified plants

Archives of toxicology, Jan 21, 2016

Research paper thumbnail of Combining exposure and effect modeling into an integrated probabilistic environmental risk assessment for nanoparticles

Environmental Toxicology and Chemistry, 2016

Research paper thumbnail of Parametric estimation ofP(X>Y) for normal distributions in the context of probabilistic environmental risk assessment

Research paper thumbnail of Assessing and monitoring impacts of genetically modified plants on agro-ecosystems: the approach of AMIGA project

Entomologia, 2014

The environmental impacts of genetically modified crops is still a controversial issue in Europe.... more The environmental impacts of genetically modified crops is still a controversial issue in Europe. The overall risk assessment framework has recently been reinforced by the European Food Safety Authority(EFSA) and its implementation requires harmonized and efficient methodologies. The EU-funded research project AMIGA − Assessing and monitoring Impacts of Genetically modified plants on Agro-ecosystems − aims to address this issue, by providing a framework that establishes protection goals and baselines for European agro-ecosystems, improves knowledge on the potential long term environmental effects of genetically modified (GM) plants, tests the efficacy of the EFSA Guidance Document for the Environmental Risk Assessment, explores new strategies for post market monitoring, and provides a systematic analysis of economic aspects of Genetically Modified crops cultivation in the EU. Research focuses on ecological studies in different EU regions, the sustainability of GM crops is estimated ...

Research paper thumbnail of A statistical simulation model for field testing of non-target organisms in environmental risk assessment of genetically modified plants

Ecology and evolution, 2014

Genetic modification of plants may result in unintended effects causing potentially adverse effec... more Genetic modification of plants may result in unintended effects causing potentially adverse effects on the environment. A comparative safety assessment is therefore required by authorities, such as the European Food Safety Authority, in which the genetically modified plant is compared with its conventional counterpart. Part of the environmental risk assessment is a comparative field experiment in which the effect on non-target organisms is compared. Statistical analysis of such trials come in two flavors: difference testing and equivalence testing. It is important to know the statistical properties of these, for example, the power to detect environmental change of a given magnitude, before the start of an experiment. Such prospective power analysis can best be studied by means of a statistical simulation model. This paper describes a general framework for simulating data typically encountered in environmental risk assessment of genetically modified plants. The simulation model, avai...

Research paper thumbnail of Enhancing the interpretation of statistical P values in toxicology studies: implementation of linear mixed models (LMMs) and standardized effect sizes (SESs)

Archives of toxicology, Jan 28, 2015

In this paper, we compare the traditional ANOVA approach to analysing data from 90-day toxicity s... more In this paper, we compare the traditional ANOVA approach to analysing data from 90-day toxicity studies with a more modern LMM approach, and we investigate the use of standardized effect sizes. The LMM approach is used to analyse weight or feed consumption data. When compared to the week-by-week ANOVA with multiple test results per week, this approach results in only one statement on differences in weight development between groups. Standardized effect sizes are calculated for the endpoints: weight, relative organ weights, haematology and clinical biochemistry. The endpoints are standardized, allowing different endpoints of the same study to be compared and providing an overall picture of group differences at a glance. Furthermore, in terms of standardized effect sizes, statistical significance and biological relevance are displayed simultaneously in a graph.

Research paper thumbnail of G-TwYST harmonisation of statistical methods for use of omics data in food safety assessment

Research paper thumbnail of A probabilistic approach for risk-benefit assessment of food substitutions: A case study on substituting meat by fish

Food and Chemical Toxicology, Apr 1, 2019

Research paper thumbnail of G-TwYST study A combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603 : statistical report, 12 months data

Research paper thumbnail of Comparative safety assessment of genetically modified crops: focus on equivalence with reference varieties could contribute to more efficient and effective field trials

Transgenic Research

The initial compositional analysis of plants plays an important role within the internationally h... more The initial compositional analysis of plants plays an important role within the internationally harmonized comparative safety assessment approach for genetically modified plants. Current EFSA guidance prescribes two types of comparison, namely difference tests with regard to a conventional comparator or control, and equivalence tests with regard to a collection of commercial reference varieties. The experience gained so far shows that most of the statistically significant differences between the test and control can be discounted based on the fact that they are still within equivalence limits of reference varieties with a presumed history of safe use. Inclusion of a test variety and reference varieties into field trial design, and of the statistical equivalence test would already suffice for the purpose of finding relevant parameters that warrant further assessment, hence both the inclusion of a conventional counterpart and the performance of difference testing can be omitted. This ...

Research paper thumbnail of FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovation

Frontiers in Toxicology

The environmental impact on health is an inevitable by-product of human activity. Environmental h... more The environmental impact on health is an inevitable by-product of human activity. Environmental health sciences is a multidisciplinary field addressing complex issues on how people are exposed to hazardous chemicals that can potentially affect adversely the health of present and future generations. Exposure sciences and environmental epidemiology are becoming increasingly data-driven and their efficiency and effectiveness can significantly improve by implementing the FAIR (findable, accessible, interoperable, reusable) principles for scientific data management and stewardship. This will enable data integration, interoperability and (re)use while also facilitating the use of new and powerful analytical tools such as artificial intelligence and machine learning in the benefit of public health policy, and research, development and innovation (RDI). Early research planning is critical to ensuring data is FAIR at the outset. This entails a well-informed and planned strategy concerning th...

Research paper thumbnail of A human biomonitoring (HBM) Global Registry Framework: Further advancement of HBM research following the FAIR principles

International Journal of Hygiene and Environmental Health, 2021

Research paper thumbnail of Equivalence Testing Approaches in Genetically Modified Organism Risk Assessment

Journal of Agricultural and Food Chemistry, 2019

Research paper thumbnail of Statement on advancing the assessment of chemical mixtures and their risks for human health and the environment

Environment International, 2020

Research paper thumbnail of Equivalence limit scaled differences for untargeted safety assessments: Comparative analyses to guard against unintended effects on the environment or human health of genetically modified maize

Food and Chemical Toxicology, 2019

Research paper thumbnail of Equivalence analysis to support environmental safety assessment: Using nontarget organism count data from field trials with cisgenically modified potato

Ecology and Evolution, 2019

Research paper thumbnail of Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats

Archives of Toxicology, 2019

Research paper thumbnail of G-TwYST study A combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603 : statistical report, 6 months data

Research paper thumbnail of G-TwYST study C a 90-day toxicity study in rats fed GM maize NK603 : statistical report

Research paper thumbnail of Variability of control data and relevance of observed group differences in five oral toxicity studies with genetically modified maize MON810 in rats

Archives of toxicology, Jan 11, 2016

The data of four 90-day feeding trials and a 1-year feeding trial with the genetically modified (... more The data of four 90-day feeding trials and a 1-year feeding trial with the genetically modified (GM) maize MON810 in Wistar Han RCC rats performed in the frame of EU-funded project GRACE were analysed. Firstly, the data obtained from the groups having been fed the non-GM maize diets were combined to establish a historical control data set for Wistar Han RCC rats at the animal housing facility (Slovak Medical University, Bratislava, Slovakia). The variability of all parameters is described, and the reference values and ranges have been derived. Secondly, the consistency of statistically significant differences found in the five studies was analysed. In order to do so, the body weight development, organ weight, haematology and clinical biochemistry data were compared between the studies. Based on the historical control data, equivalence ranges for these parameters were defined, and the values measured in the GM maize-fed groups were compared with these equivalence ranges. Thirdly, the...

Research paper thumbnail of Proposed criteria for the evaluation of the scientific quality of mandatory rat and mouse feeding trials with whole food/feed derived from genetically modified plants

Archives of toxicology, Jan 21, 2016

Research paper thumbnail of Combining exposure and effect modeling into an integrated probabilistic environmental risk assessment for nanoparticles

Environmental Toxicology and Chemistry, 2016

Research paper thumbnail of Parametric estimation ofP(X>Y) for normal distributions in the context of probabilistic environmental risk assessment

Research paper thumbnail of Assessing and monitoring impacts of genetically modified plants on agro-ecosystems: the approach of AMIGA project

Entomologia, 2014

The environmental impacts of genetically modified crops is still a controversial issue in Europe.... more The environmental impacts of genetically modified crops is still a controversial issue in Europe. The overall risk assessment framework has recently been reinforced by the European Food Safety Authority(EFSA) and its implementation requires harmonized and efficient methodologies. The EU-funded research project AMIGA − Assessing and monitoring Impacts of Genetically modified plants on Agro-ecosystems − aims to address this issue, by providing a framework that establishes protection goals and baselines for European agro-ecosystems, improves knowledge on the potential long term environmental effects of genetically modified (GM) plants, tests the efficacy of the EFSA Guidance Document for the Environmental Risk Assessment, explores new strategies for post market monitoring, and provides a systematic analysis of economic aspects of Genetically Modified crops cultivation in the EU. Research focuses on ecological studies in different EU regions, the sustainability of GM crops is estimated ...

Research paper thumbnail of A statistical simulation model for field testing of non-target organisms in environmental risk assessment of genetically modified plants

Ecology and evolution, 2014

Genetic modification of plants may result in unintended effects causing potentially adverse effec... more Genetic modification of plants may result in unintended effects causing potentially adverse effects on the environment. A comparative safety assessment is therefore required by authorities, such as the European Food Safety Authority, in which the genetically modified plant is compared with its conventional counterpart. Part of the environmental risk assessment is a comparative field experiment in which the effect on non-target organisms is compared. Statistical analysis of such trials come in two flavors: difference testing and equivalence testing. It is important to know the statistical properties of these, for example, the power to detect environmental change of a given magnitude, before the start of an experiment. Such prospective power analysis can best be studied by means of a statistical simulation model. This paper describes a general framework for simulating data typically encountered in environmental risk assessment of genetically modified plants. The simulation model, avai...

Research paper thumbnail of Enhancing the interpretation of statistical P values in toxicology studies: implementation of linear mixed models (LMMs) and standardized effect sizes (SESs)

Archives of toxicology, Jan 28, 2015

In this paper, we compare the traditional ANOVA approach to analysing data from 90-day toxicity s... more In this paper, we compare the traditional ANOVA approach to analysing data from 90-day toxicity studies with a more modern LMM approach, and we investigate the use of standardized effect sizes. The LMM approach is used to analyse weight or feed consumption data. When compared to the week-by-week ANOVA with multiple test results per week, this approach results in only one statement on differences in weight development between groups. Standardized effect sizes are calculated for the endpoints: weight, relative organ weights, haematology and clinical biochemistry. The endpoints are standardized, allowing different endpoints of the same study to be compared and providing an overall picture of group differences at a glance. Furthermore, in terms of standardized effect sizes, statistical significance and biological relevance are displayed simultaneously in a graph.