Sf. Velazquez et al., COMBINATION OF CANCER DATA IN QUANTITATIVE RISK ASSESSMENTS - CASE-STUDY USING BROMODICHLOROMETHANE, Risk analysis, 14(3), 1994, pp. 285-291
There are often several data sets that may be used in developing a qua
ntitative risk estimate for a carcinogen. These estimates are usually
based, however, on the dose-response data for tumor incidences from a
single sex/strain/species of animal. When appropriate, the use of more
data should result in a higher level of confidence in the risk estima
te. The decision to use more than one data set (e.g., representing dif
ferent animal sexes, strains, species, or tumor sites) can be made fol
lowing biological and statistical analyses of the compatibility of the
se data sets. Biological analysis involves consideration of factors su
ch as the relevance of the animal models, study design and execution,
dose selection and route of administration, the mechanism of action of
the agent, its pharmacokinetics, any species- and/or sex-specific eff
ects, and tumor site specificity. If the biological analysis does not
prohibit combining data sets, statistical compatibility of the data se
ts is then investigated. A generalized likelihood ratio test is propos
ed for determining the compatibility of different data sets with respe
ct to a common dose-response model, such as the linearized multistage
model. The biological and statistical factors influencing the decision
to combine data sets are described, followed by a case study of bromo
dichloromethane.