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Quality Review Procedures Necessary for Rodent Pathology Databases and Toxicogenomic Studies: The National Toxicology Program Experience

Laboratory for Experimental Pathology, Environmental Toxicology Program

Joseph K. Haseman

Biostatistics Branch, Environmental Diseases and Medicine Program

Michael D. Waters

National Center for Toxicogenomics, NIEHS, PO Box 12233, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709

Jerry F. Hardisty

Experimental Pathology Laboratories, Inc., Suite 5000, 615 Davis Drive, Durham, NC 27713

Robert C. Sills

Laboratory for Experimental Pathology, Environmental Toxicology Program

Accuracy of the pathology data is crucial since rodent studies often provide critical data used for setting human chemical exposure standards. Diagnoses represent a judgment on the expected biological behavior of a lesion and peer review can improve diagnostic accuracy and consistency. With the conduct of 500 2-year rodent studies, the National Toxicology Program (NTP) has refined its process for comprehensive review of the pathology data and diagnoses. We have found that careful judgment can improve and simplify the review, whereas simply applying a set review procedure may not assure study quality. The use of reviewing pathologists and pathology peer review groups is a very effective procedure to increase study quality with minimal time and cost. New genomic technology to assess differential gene expression is being used to predict morphological phenotypes such as necrosis, hyperplasia, and neoplasia. The challenge for pathologists is to provide uniform pathology phenotypes that can be correlated with the gene expression changes. The lessons learned in assuring data quality in standard rodent studies also applies to the emerging field of toxicogenomics.

Key Words: Cancer • bioassay • rodent studies • F344 rat • B6C3F1 mouse • toxicology • toxicogenomics.

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