Current status of application of statistical methods for rodent carcinogenicity studies
Carcinogenicity studies in rodents are important in nonclinical safety evaluation of new drugs.Carcinogenicity studies have long durations and large amounts of data,the appropriateness and selection scientificity of statistical methods are also likely to affect their study results and conclusions.This review firstly introduces statistical methods of survival analysis and tumor incidence currently used in carcinogenicity studies.Secondly,the selection of statistical methods for survival analysis and tumor incidence is summarized.Finally,by comparing the differences between statistical selecting methods chosen by sponsors,the reviewers of the U.S.Food and Drug Administration(FDA)and the National Toxicology Program(NTP),the sources and implication of these differences are analyzed and discussed.Furthermore,the review summarizes the ideas for designing statistical analysis in carcinogenicity studies.We hope that all the summary and analysis above can provide a reference for designing non-clinical carcinogenicity studies.
nonclinical safety evaluation of drugscarcinogenicity studyFood and Drug Administration(FDA)National Toxicology Program(NTP)survival analysistumor incidence
NETL
NSTL
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