Regulatory Forum

The Regulatory Forum publishes articles designed to facilitate discussion of current standards and possible improvements in regulatory pathology practices. STP position papers that define high quality pathology practices for regulatory purposes will be published in the Regulatory Forum. These position papers are consensus documents written by groups of experts with the encouragement of the leadership of STP. In addition, the Regulatory Forum will contain opinion papers1 and provocative articles that challenge current practices and foment discussion of better ways to apply pathology skills to risk assessment. Topics may range from purely regulatory issues to primarily scientific concerns. Formal articles, brief communications, and letters to the editor are appropriate. Feedback is welcome and appreciated. Please send your submissions and comments to Dr. Roy Kerlin at [e-mail].

The article by Roth et al. on managing high mortality in rodent carcinogenicity studies is the first opinion paper to be published in the Regulatory Forum. This paper recommends options for obtaining optimal study data when mortality in carcinogenicity studies is high. The editors of Toxicologic Pathology hope that this will be the first in a long series of articles that challenge readers to consider ways to advance the science of toxicologic pathology and regulatory risk assessment. Contributions that critically discuss current practices in toxicologic pathology and ways to improve these practices are welcome.

Roth et al. bring to readers a clear and nonmathematicaldiscussion of how statistical considerations can guide selection of methods that provide the most valuable data when one or more groups in 2-year rodent carcinogenicity studies suffer early high mortality. This discussion expands on the 2002 STP position paper “The Society of Toxicologic Pathology’s Recommendations on Statistical Analysis of Rodent Carcinogenicity Studies.” A better understanding by pathologists of the statistical principles underlying rodent bioassays and the ways to obtain the maximal amount of high quality data from rodent carcinogenicity studies will improve the quality of pathologists’ work.