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Improving the reliability of observational epidemiology
Abstracts / Toxicology Letters 205S (2011) S19–S35
W1—Science in society: Improving the credibility of research in health and environmental science
W01-1 Improving the reliability of observational epidemiology G. Swaen Epidemiology, Dow Chemical, Maastricht, The Netherlands Improving the reliability of observational epidemiology Gerard Swaen, The Dow Chemical Company, Terneuzen, The Netherlands Abstract Epidemiological studies provide the most direct evidence on potential adverse health effects from exposure to chemicals or other potential risk factors. On occasion they play a key role in chemicals risk assessment and therefore it is crucial that they are of excellent quality, reliable, credible and transparent. However, publication bias and perhaps even more important, reporting bias, are aspects that potentially mitigate their reliability and credibility. These potential biases have been investigated by means of meta-studies. The findings of these studies will be reviewed. Next, a parallel will be drawn with the area of clinical epidemiology, where these biases have lead to great concern and where measures to reduce them have been taken. Finally a number of recommendations will be made to improve the quality and reliability of observational epidemiology studies.
S19
chemical substances in Europe. The REACH and CLP Regulations will be used as examples; presenting the different mechanisms that the Scientific Committees of the European Chemicals Agency (ECHA), and in particular the Committee for Risk Assessment (RAC), have developed for ensuring, a top scientific quality and objectivity of their scientific discussions, as well as a proper balance for ensuring a transparent process even when part of the discussions are based on confidential information. RAC has already adopted a number of scientific opinions on Harmonised Classification and Labelling, Restrictions Proposals, and targeted mandates following the request of the ECHA Executive Director. All opinions and relevant supporting documentation are published after adoption in the ECHA web page under a RAC dedicated entry. The ECHA Scientific Committee processes are described in publicly available documents and include consultations and specific procedures for the involvement of Stakeholder Organisations. The RAC procedures and the current experience will be used as examples on how to achieve objectivity and transparency when dealing with scientifically complex discussions in the regulatory arena. doi:10.1016/j.toxlet.2011.05.077
W01-4 Toxicology and health risk assessor training to support chemicals safety research H. Hakansson ∗ , A. Hanberg, J. Zilliacus
doi:10.1016/j.toxlet.2011.05.075 Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden W01-2 Avoiding bias in safety testing design P. Calow Office of Research And Economic Development, University of Nebraska Lincoln, Lincoln, USA All scientists are biased, no matter what their backgrounds or affiliations, so what is it about the scientific method that overcomes this and which makes science so successful? Key features are transparency and critical peer scrutiny. These general issues will be will be considered in terms of the scientific basis of risk assessment, including the design of safety testing procedures, particularly as applied to industrial chemicals. doi:10.1016/j.toxlet.2011.05.076
W01-3 Objectivity and transparency in the use of scientific knowledge in regulatory decision-making J.V. Tarazona Committees Secretariats Unit, European Chemicals Agency, Helsinki, Finland
Toxicology and health risk assessment is gaining more and more public attention due to the fact that we all carry a mixture of chemicals in our bodies. Many of those chemicals have been tested according to legal rules, while others were not tested by regulatory means, since, at the time of their development and/or market introduction there were no testing requirements or sufficient awareness that these chemicals could end up in biota at levels of concern. In Europe societal concern of chemical exposures is illustrated by the introduction of REACH and by ongoing efforts to harmonize toxicology training and to establish health risk assessor training. For REACH to work as intended, new knowledge and infrastructure need to be established. The new knowledge, which is needed to establish appropriate and efficient tools for screening as well as for full evaluation and interpretation of toxicological properties, will be dependent on access to reliable and high quality research results provided by well-educated toxicologists and risk assessors. Since the basic training fundaments in toxicology as well as health risk assessment sciences still are scattered and partly driven as pilot projects across Europe, the need is urgent to coordinate, harmonize and make permanent the ongoing training efforts on master, PhD and post-doc levels. Such a joint effort by society, academy and industry would be a vital step to efficiently meet modern challenges in toxicology and health risk assessment sciences and for Europe to take an international front position driven by the societal need of safe chemicals. doi:10.1016/j.toxlet.2011.05.078
Objectivity and transparency are basic principles in all scientific disciplines; nevertheless, there are several specific connotations when the scientific discussions and conclusions are targeted discussions in the regulatory context; as the main aim of regulatory science is to provide top quality scientific advice to decision makers. The presentation will cover the use and communication of scientific results, and in particular the outcome of health and environmental hazard and risk assessments, in the regulation of
W1—Science in society: Improving the credibility of research in health and environmental science
W01-1 Improving the reliability of observational epidemiology G. Swaen Epidemiology, Dow Chemical, Maastricht, The Netherlands Improving the reliability of observational epidemiology Gerard Swaen, The Dow Chemical Company, Terneuzen, The Netherlands Abstract Epidemiological studies provide the most direct evidence on potential adverse health effects from exposure to chemicals or other potential risk factors. On occasion they play a key role in chemicals risk assessment and therefore it is crucial that they are of excellent quality, reliable, credible and transparent. However, publication bias and perhaps even more important, reporting bias, are aspects that potentially mitigate their reliability and credibility. These potential biases have been investigated by means of meta-studies. The findings of these studies will be reviewed. Next, a parallel will be drawn with the area of clinical epidemiology, where these biases have lead to great concern and where measures to reduce them have been taken. Finally a number of recommendations will be made to improve the quality and reliability of observational epidemiology studies.
S19
chemical substances in Europe. The REACH and CLP Regulations will be used as examples; presenting the different mechanisms that the Scientific Committees of the European Chemicals Agency (ECHA), and in particular the Committee for Risk Assessment (RAC), have developed for ensuring, a top scientific quality and objectivity of their scientific discussions, as well as a proper balance for ensuring a transparent process even when part of the discussions are based on confidential information. RAC has already adopted a number of scientific opinions on Harmonised Classification and Labelling, Restrictions Proposals, and targeted mandates following the request of the ECHA Executive Director. All opinions and relevant supporting documentation are published after adoption in the ECHA web page under a RAC dedicated entry. The ECHA Scientific Committee processes are described in publicly available documents and include consultations and specific procedures for the involvement of Stakeholder Organisations. The RAC procedures and the current experience will be used as examples on how to achieve objectivity and transparency when dealing with scientifically complex discussions in the regulatory arena. doi:10.1016/j.toxlet.2011.05.077
W01-4 Toxicology and health risk assessor training to support chemicals safety research H. Hakansson ∗ , A. Hanberg, J. Zilliacus
doi:10.1016/j.toxlet.2011.05.075 Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden W01-2 Avoiding bias in safety testing design P. Calow Office of Research And Economic Development, University of Nebraska Lincoln, Lincoln, USA All scientists are biased, no matter what their backgrounds or affiliations, so what is it about the scientific method that overcomes this and which makes science so successful? Key features are transparency and critical peer scrutiny. These general issues will be will be considered in terms of the scientific basis of risk assessment, including the design of safety testing procedures, particularly as applied to industrial chemicals. doi:10.1016/j.toxlet.2011.05.076
W01-3 Objectivity and transparency in the use of scientific knowledge in regulatory decision-making J.V. Tarazona Committees Secretariats Unit, European Chemicals Agency, Helsinki, Finland
Toxicology and health risk assessment is gaining more and more public attention due to the fact that we all carry a mixture of chemicals in our bodies. Many of those chemicals have been tested according to legal rules, while others were not tested by regulatory means, since, at the time of their development and/or market introduction there were no testing requirements or sufficient awareness that these chemicals could end up in biota at levels of concern. In Europe societal concern of chemical exposures is illustrated by the introduction of REACH and by ongoing efforts to harmonize toxicology training and to establish health risk assessor training. For REACH to work as intended, new knowledge and infrastructure need to be established. The new knowledge, which is needed to establish appropriate and efficient tools for screening as well as for full evaluation and interpretation of toxicological properties, will be dependent on access to reliable and high quality research results provided by well-educated toxicologists and risk assessors. Since the basic training fundaments in toxicology as well as health risk assessment sciences still are scattered and partly driven as pilot projects across Europe, the need is urgent to coordinate, harmonize and make permanent the ongoing training efforts on master, PhD and post-doc levels. Such a joint effort by society, academy and industry would be a vital step to efficiently meet modern challenges in toxicology and health risk assessment sciences and for Europe to take an international front position driven by the societal need of safe chemicals. doi:10.1016/j.toxlet.2011.05.078
Objectivity and transparency are basic principles in all scientific disciplines; nevertheless, there are several specific connotations when the scientific discussions and conclusions are targeted discussions in the regulatory context; as the main aim of regulatory science is to provide top quality scientific advice to decision makers. The presentation will cover the use and communication of scientific results, and in particular the outcome of health and environmental hazard and risk assessments, in the regulation of