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© 1988 Oxford University Press

research-article

A Guide to the Statistical Analysis of Long-Term Carcinogenicity Assays1,2

BARBARA MCKNIGHT

Department of Biostatistics, University of Washington Seattle, Washington 98195

Received June 11, 1987; accepted August 17, 1987

A Guide to the Statistical Analysis of Long-Term Carcinogenicity Assays. MCKNIGHT, B. (1988). Fundam. Appl. Toxicol. 10, 355–364. Statistical methods for analyzing data from chronic carcinogenicity bioassays are reviewed. When treatment groups do not show marked differences in tumor-free death rates, methods that compare the crude proportions of animals that develop tumors can be recommended as valid and powerful comparisons of age-specific tumor incidence rates. When the age at tumor onset can be observed, techniques of survival analysis such as the logrank test can adjust for differing tumor-free mortality rates. If tumors are strictly nonlethal, the age-adjusted comparison of tumor prevalence among dying animals compares age-specific tumor incidence rates. When tumors are occult or of intermediate lethality and when tumor-free death rates differ substantially, a variety of techniques are available, but most are computationally intensive and rely either on the collection of additional data or on additional assumptions that may not be met.


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