Statistical Considerations in the Evaluation of Graded Responses in Carcinogenesis Studies

In the evaluation of laboratory animal carcinogenicity studies, primary emphasis is given to whether or not increased incidences of site-specific neoplasms are observed in treated groups relative to controls (International Agency for Research on Cancer, 1980; Office of Science and Technology Policy, 1985). Related nonneoplastic lesions are also considered in the overall interpretation of the data.