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Michael H. Dong MPH, DrPA, PhD

Epidemiology and Risk Assessment (4th of 10 Lectures on Toxicologic Epidemiology). Michael H. Dong MPH, DrPA, PhD.  readings. Taken in the early ’90s, when desktop computers were still a luxury. Learning Objectives.

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Michael H. Dong MPH, DrPA, PhD

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  1. Epidemiology and Risk Assessment (4th of 10 Lectures onToxicologic Epidemiology) Michael H. Dong MPH, DrPA, PhD  readings

  2. Taken in the early ’90s, when desktop computers were still a luxury.

  3. Learning Objectives • Appreciate the recent advances in epidemiology pertinent to health risk assessment (RA). • Study the epidemiologic approaches to human exposure assessment. • Learn about the biomarkers used in epidemiology as well as in RA.

  4. Performance Objectives • Able to list and describe the recent advances in epidemiology pertinent to health risk assessment (RA). • To describe the epidemiologic approaches to exposure assessment. • To discuss the strengths and limitations of the use of biomarkers in epidemiology and in RA.

  5. Health Risk Perception Health Statutes & Regulations Toxicity Studies/Data Research Developments

  6. Recent Advances in Epidemiology • Branching out from general epidemiology. • Specialty disciplines now including: psychosocial; pharmaco-; occupational; environmental; nutritional; genetic; molecular; cancer epidemiology; and more.

  7. Psychosocial Epidemiology • Determinants of disease: social; psychological; behavioral factors. • Not directly of regulatory concern. • But offering valuable information for health risk assessment.

  8. Pharmacoepidemiology • Studying the use, efficacy, and safety of pharmaceuticals. • Beginning to flourish in 1980s. • Adding a new twist to the regular course of health risk assessment.

  9. Nutritional Epidemiology • Studying the role of nutrition/ diet in the etiology of disease. • Nutritional epidemiologists conducted the first clinical trials. • Human and social factors affect dietary intake.

  10. Genetic and Molecular Epidemiology • Actually two separate branches. • Molecular: studying with known genes. • Genetic: studying with unknown genes. • Useful in flagging preclinical effects of exposure.

  11. Cancer Epidemiology • Related closely to molecular and genetic epidemiology. • Now more into identifying and quantifying nutritional and other environmental carcinogens. • Epidemiology on cancer effects becoming more available for health risk assessment.

  12. Environmental & Occu- pational Epidemiology • Actually two separate branches. • But both are linked together due to studying exposures to common toxic agents which are relatively more preventable. • Occupational epidemiology tends to use biomarkers more.

  13. Clinical Trials • Were conducted as early as 1537. • Sometimes referred to as human intervention trials. • Used to test not only treatment but also adverse (side) effects. • A simplified or special version of health risk assessment.

  14. Phases of Regulatory Clinical Trials • Preclinical: a series of laboratory or animal studies. • Trial Phases: (I) testing for human safety; (II) testing for efficacy; (III) overall trial assessment. • Postlicensing surveillance. • Ideally should follow a double-blind randomization design.

  15. Meta-Analysis of Clinical Trial Data • First used around 1976. • Uses routine statistical methods on data pooled from various trials typically not following the same study protocol. • A controversial technique unacceptable to some statisticians.

  16. Basic Epidemiologic Study Designs • Using primarily observational data. • Descriptive studies. • Cohort studies. • Case-control studies. • Cross-sectional studies. • Ecological studies.

  17. Guidance for Epidemiology Studies • Epidemiologic study designs can be used to assess human exposures. • Good epidemiology practices by: International Society for Pharmaco-epidemiology; International Epidemiological Association; and World Health Organization.

  18. Human Exposure: Basic Definition • Human exposure to a toxic agent is defined as the (level of) contact of a person with the toxicant. • Human exposures can be categorized by route of entry; exposure source; and exposure duration.

  19. Human Exposure: Methods and Advances • Methods: direct monitoring of individuals; and from measurement of environmental levels. • Advances: Social Readjustment Rating Scale; Stress Process Model; geographic information system; biomarkers, etc.

  20. Use of Biomarkers • Limitations: low detection levels; compliance with sample collection. • Related to biological monitoring. • Types of biomarkers: for exposure; adverse response; susceptibility. • Best estimate for aggregate dose.

  21. Criteria of Selection of Biomarkers • Criteria: availability; specificity; invasiveness; persistence; time-to-appearance; intra- and interperson variability. • Multiple factors causing biological variation in dose-response.

  22. Biomarkers: Legal and Ethical Considerations • Legal authority as barrier; privacy act. • Ethical implications concerning the subject’s right-to-know. • These considerations making biomarkers useful at a slow pace.

  23. Overview of Next Lecture Toxicologic Side of Epidemiology • Illustrating this side through use of historical cases. • Epidemiologic activities might have initiated/dominated in these cases. • But the toxicologic side was also there and critical.

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