Methodology for statistical analysis of SENCAR mouse skin assay data.

Various response measures and statistical methods appropriate for the analysis of data collected in the SENCAR mouse skin assay are examined. The characteristics of the tumor response data do not readily lend themselves to the classical methods for hypothesis testing. The advantages and limitations of conventional methods of analysis and methods recommended in the literature are discussed. Several alternative response measures that were developed specifically to answer the problems inherent in the data collected in the SENCAR bioassay system are described. These measures take into account animal survival, tumor multiplicity, and tumor regression. Statistical methods for the analysis of these measures to test for a positive dose response and a dose-response relationship are discussed. Sample data from representative initiation/promotion studies are used to compare the response measures and methods of analysis.