Statistical Aspects of Using Biologic Markers

This expository paper surveys a variety of statistical issues pertinent to the design and analysis of studies involving biologic markers of human genotoxic exposure. Examples with cytogenetic and mutagenic end points are presented. One principal theme is the valuable interplay of ideas among statistical analyses for in vitro, in vivo and human assays for genetic toxicity; e.g., statistical analysis of sister chromatid exchanges in vitro is suggestive of an analytical approach to the study of sister chromatid exchanges in humans. Other topics discussed include (i) combining information from a series of studies of a common suspect genotoxic exposure and (ii) the utility of historical control information.