Carcinogenicity evaluation: comparison of tumor data from dual control groups in the Sprague-Dawley rat.
Following recent clarification in Europe that a single control group is now acceptable for rodent carcinogenicity studies, the use of dual controls may be reduced or disappear. To date, virtually nothing has been published on whether this latter situation has improved the identification of tumorigenic risk potential in these studies. In this paper, the results of 13 rat carcinogenicity studies, performed between 1991 and 2002, with 2 control groups, are presented. Although no major differences in tumor incidences between these dual control groups were found, some interstudy variation occurred. In cases where a notable difference was seen, the use of 2 control groups, as well as robust, contemporary background data, allowed an easier interpretation of findings in drug-treated groups. Thus, the continued use of dual control groups has a vital role in the assessment of tumoriogenic risk. The paper also presents an update on survival, on the range and extent of background spontaneous neoplasms, and comments on genetic drift in this commonly used rat strain.
Baldrick
Paul
P
Scientific and Regulatory Consulting, Covance Laboratories Ltd., Otley Road, Harrogate, HG3 1PY North Yorkshire, United Kingdom. paul.baldrick@covance.com
D000818:Animals; D015197:Carcinogenicity Tests / Q000706:statistics & numerical data*; D035061:Control Groups; D005260:Female; D015994:Incidence; D008297:Male; D009369:Neoplasms / Q000453:epidemiology* / Q000473:pathology*; D051381:Rats; D012016:Reference Values; D006113:United Kingdom / Q000453:epidemiology