Report of the State-of-the-Science Workshop: Evaluation of Epidemiological Data Consistency for Application in Regulatory Risk Assessment (Final Report)
EPA recognized a need to improve approaches to assessing consistency in epidemiological study results and the Johns Hopkins Risk Sciences and Public Policy Institute organized a workshop held in Baltimore, Maryland in September 2010 to identify and discuss key methodological issues, and to develop recommendations for qualitative and quantitative approaches to addressing those issues. The workshop was co-sponsored by the U.S. Environmental Protection Agency, the National Institute of Environmental Health Sciences, and the National Institute for Occupational Safety and Health, with additional support provided by Health Canada.
A multi-disciplinary approach was utilized for the workshop, involving well recognized experts from a variety of fields, and the invited participants were drawn from academia, industry, government, and the public interest sectors. This report provides a summary of selected epidemiology methodological issues discussed by the workshop participants and provides the key findings and recommendations for future approaches to addressing this issue.
BackgroundEpidemiological studies play a key role in the assessment of risks associated with exposures to environmental agents and for development of regulatory standards covering environmental and occupational settings. The strengths and weaknesses of epidemiological methodology, as well as the overall value of the use of epidemiological evidence to support regulatory standards, have been widely discussed in the scientific and public health policy literature. Issues related to the presentation of epidemiological results that inform risk assessments, the need to apply modern biostatistical techniques to epidemiological data, and methodological challenges in the use of epidemiological data in quantitative risk assessment have also been noted.
When evaluating epidemiological findings in support of causal inference, a key uncertainty stems from apparent inconsistency across studies. Evaluations of consistency are often controversial, and contradictory determinations may result from varying perspectives. The evaluation of consistency in epidemiological results has been discussed for more than 50 years, and become more nuanced as the field of epidemiology (and specifically environmental epidemiology) has matured. Differences in exposure metrics and the range of exposures could lead to differences in observed estimates among studies. The evaluation of consistency of findings across a diverse collection of epidemiological studies is central to evaluating that body of evidence for supporting causal inferences for hazard identification, one of the core components of environmental health risk assessment. There remains a need for constructive approaches to objectively and transparently evaluate consistency. This workshop report provides recommendations regarding approaches to assist in the evaluation of consistency in epidemiological study results.
|Sep 2010||Workshop held.|
|Jun 2011||Final report prepared.|
|Jan 2013||EPA released the final report.|
This document has been reviewed in accordance with U.S. Environmental Protection Agency policy and approved for publication. Mention of trade names or commercial products does not constitute endorsement or recommendation for use.
- (23 pp, 256 KB, about PDF)