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Best Practices for Use of Historical Control Data of Proliferative Rodent Lesions.
Citation:
Keenan, C., S. Elmore, S. Francke-Carroll, R. Kemp, R. Kerlin, S. Peddada, J. Pletcher, M. Rinke, S. P. Schmidt, I. Taylor, AND D. WOLF. Best Practices for Use of Historical Control Data of Proliferative Rodent Lesions. TOXICOLOGIC PATHOLOGY. Society of Toxicology, RESTON, VA, 37:679-693, (2009).
Impact/Purpose:
The Historical Control Data Working Group under the direction of the Scientific and Regulatory Policy Committee (SRPC) of the Society of Toxicologic Pathology (STP) was tasked with reviewing the current scientific practices, regulatory guidance and relevant literature pertaining to rodent microscopic historical control data (HCD) of proliferative lesions in order to provide best practice recommendations for locating, generating and applying such data.
Description:
The Historical Control Data Working Group under the direction of the Scientific and Regulatory Policy Committee (SRPC) of the Society of Toxicologic Pathology (STP) was tasked with reviewing the current scientific practices, regulatory guidance and relevant literature pertaining to rodent microscopic historical control data (HCD) of proliferative lesions in order to provide best practice recommendations for locating, generating and applying such data. The Working Group focused exclusively on HCD of neoplastic and proliferative lesions from non-clinical rodent carcinogenicity studies. The HCD Working Group recommends the following consensus principles to guide the use of HCD of proliferative lesions from chronic rodent (rats/mice) bioassays: • The concurrent control group is always the most relevant. • HCD from the laboratory conducting the current study is preferred. • HCD that underwent an independent peer review process are generally more reliable • HCD may be useful in the interpretation of rare tumors, marginally increased proliferative changes and unexpected increases or decreases of tumor incidences in study control animals. • HCD should be from the same species, strain, sex, and study duration as the study under review. • The type of housing (single vs. group) should be taken into consideration. • HCD must be derived from studies utilizing the same feeding regimen. • Treatment-related effects on survival and/or bodyweights must be taken into consideration. • The route of administration and vehicle used should be taken into consideration. • A simple reference range for a given proliferative change may be used but may be misleading. • Statistical tools should be considered in the context of sound biological principles. o interquartile range o boxplot o formal statistical analysis • Published HCD should be evaluated carefully, but may provide guidance in evaluating data associated with particular effects such as exceedingly rare neoplasms. • HCD is best used as a quality assurance tool.