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Updated: Jul 1, 2025

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

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|March 6, 2024
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Summary

This guide helps reviewers statistically analyze nonclinical tumor data by providing a harmonized hierarchy for tumor types. It standardizes tumor nomenclature for improved data interpretation and regulatory submissions.

Keywords:
INHANDSENDcarcinogenicity studiesneoplasmtumor combinationtumor statistical analysis

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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.