A Case for Good Epidemiology Practice Guidelines for Regulatory Risk Assessment

After a summer hiatus, the HESI Environmental Epidemiology Committee is resuming their webinar series with a presentation by Dr. Julie Goodman (Gradient) in which she will make "A Case for Good Epidemiology Practice Guidelines for Regulatory Risk Assessment." Please see the full webinar slides here.

Webinar Abstract
Toxicology studies submitted for regulatory purposes must comply with Good Laboratory Practice (GLP) guidelines, which ensure study quality, reliability, and integrity. While there are several frameworks for assessing the quality of epidemiology studies, there are no universal "Good Epidemiology Practice" (GEP) guidelines for human studies. These guidelines are sorely needed, as epidemiology evidence has been factoring more prominently in regulatory risk assessments of pesticides and other chemicals. Recently, a matrix was developed that characterizes the needs of risk of assessors when using epidemiology data for hazard identification, exposure assessment, and dose-response assessment. We developed a list of considerations for GEP for environmental epidemiology studies that addresses these needs, with a particular focus on pesticides, and proposed guidelines for pesticide exposure assessment. GEP guidelines will facilitate the conduct of higher-quality epidemiology studies that can be used as a basis for more scientifically sound regulatory risk assessment and policy making, not only for pesticides, but other environmental exposures as well.

Julie E. Goodman, Ph.D., DABT, FACE, ATS
Dr. Goodman is a Principal at Gradient, an environmental and risk sciences consulting firm. She is board certified in toxicology, and a fellow of both the American College of Epidemiology and the Academy of Toxicological Sciences. Her consulting practice consists of assessing human health risks from chemicals in consumer products, pharmaceuticals, and medical devices, as well as chemicals in the workplace and the environment. Her primary responsibilities at Gradient include the design, analysis, and interpretation of epidemiology studies, as well as the evaluation of chemical exposures, toxicity data, and disease clusters. Dr. Goodman has extensive experience in the formulation of weight-of-evidence (WoE) and systematic review methods, with a particular focus on study quality and risk of bias, and the conduct of these types of reviews. This work has included critically reviewing many systematic review protocols (e.g., TSCA, IRIS, TCEQ, OHAT, NAAQS, OPP, IARC). It also has involved developing novel methods for risk-of-bias and study quality analysis. She has authored numerous peer-reviewed publications, including systematic reviews of substances such as PM, O3, naphthalene, formaldehyde, asphalt, styrene, and asbestos, and a wide array of health conditions. As an adjunct faculty member in the Department of Epidemiology at the Harvard T. H. Chan School of Public Health, Dr. Goodman taught a class on meta-analysis for several years. Before joining Gradient, Dr. Goodman was a Cancer Prevention Fellow at the National Cancer Institute.