Statistical Issues in Interpretation of Chronic Bioassay Tests for Carcinogenicity

The interpretation of chronic bioassay tests for carcinogenicity requires that the data be appropriately recorded. A "case history" for each animal links the pathology data for each organ of each animal to the length of its life. This information can be used in interpretation of the tumor incidences in light of the survival information. The role of historical controls was discussed, and the use of significance tests in a multidisciplinary approach to the assessment of the pattern of tumor response was suggested. Multiple comparison methods valid for the interpretation of continuous (or measurement) data do not apply to the discrete data analyses used in these studies. The ideas and methods of these studies were applied to an animal study of chloroform.