title: Use of statistics when examining lifetime studies in rodents to detect carcinogenicity.
abstract: The lifetime assay for carcinogenicity that subjects groups of 50 animals per sex per dose to three doses and a control is examined for its statistical properties. Using the standard formulation of tests of hypothesis, it is shown that there is a 20-50% chance of having a false positive and that it is possible to define a "weak carcinogen" in terms of the degree of effect that would produce a false negative less than 5% of the time. Whether hypothesis testing is a proper use of statistics in this context is questioned, and alternatives are proposed.
mesh_terms: D000818:Animals; D002273:Carcinogens / Q000494:pharmacology*; D004353:Drug Evaluation, Preclinical / Q000379:methods; D005189:False Positive Reactions; D011336:Probability; D012107:Research Design; D012377:Rodentia; D013223:Statistics as Topic
chemical_list: D002273:Carcinogens