Guide for Combining Primary Tumors for Statistical Analysis in Rodent Carcinogenicity Studies

Area of Science:

• Toxicologic Pathology
• Biostatistics
• Regulatory Science

Background:

• Nonclinical tumor data analysis requires standardized nomenclature for accurate statistical interpretation.
• Existing tumor terminologies can be disparate, complicating data aggregation and analysis.
• The U.S. Food and Drug Administration (FDA) requested a unified approach to tumor data interpretation.

Purpose of the Study:

• To create a Tumor Combination Guide for statistical analysis of nonclinical tumor data.
• To correlate tumor names from International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) with the NEOPLASM controlled terminology (CT) in the Standard for Exchange of Nonclinical Data (SEND).
• To assist pharmacology/toxicology reviewers, biostatisticians, and pathologists in interpreting and analyzing tumor data.

Main Methods:

• Development of a higher-level hierarchy for tumor types and categories.
• Correlation of INHAND tumor names with SEND NEOPLASM CT codes.
• Provision of instructions and examples in a tabular format for informed decisions on combining tumor data.
• Strategy for combining tumor types based on scientific criteria from literature.

Main Results:

• A comprehensive guide correlating INHAND and SEND tumor terminologies is established.
• The guide facilitates informed decisions for combining tumor data for statistical analysis.
• It provides a standardized framework for interpreting nonclinical tumor data.

Conclusions:

• The Tumor Combination Guide enhances the statistical analysis of nonclinical tumor data.
• It promotes consistency and clarity in reporting and interpreting toxicologic pathology findings.
• The guide will be updated to reflect evolving SEND and INHAND terminology.