Biological markers in epidemiologic research.

This paper identifies some of the issues relevant to the use of biological markers in epidemiologic research. Foremost among these are clarity of definitions and marker classification. Illustrations of markers in the categories of internal dose, biological effective dose, biological response, disease, and susceptibility are presented with a theoretical model for the interrelationship among these. Issues faced by epidemiologists in selecting markers for specific studies concern exposure complexity, marker specificity, marker persistence, time to appearance, and the use of target vs. surrogate biological media. Feasibility issues concern sample collection, transport, storage, and characteristics of the laboratory assay. The rationale for biological markers in epidemiologic research is strong in that markers have the potential for (1.) improving the accuracy of our "exposure variables," (2.) permitting the identification of preclinical disease and providing opportunities for prevention, (3.) allowing for more homogeneous and etiologically relevant classifications of disease, and (4.) enhancing our understanding of the biological processes leading to disease occurrence, thereby strengthening the interpretation of epidemiologic data and the theoretical framework from which we formulate research questions.