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Using historical controls in the analysis of developmental toxicity data

L Ryan1

  • 1Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115.

Biometrics
|December 1, 1993
PubMed
Summary

This study introduces a new statistical trend test for developmental toxicity studies using historical control data. The quasi-likelihood method accounts for litter effects, improving the analysis of correlated binary outcomes in toxicology research.

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Area of Science:

  • Toxicology
  • Biostatistics
  • Pharmacology

Background:

  • Historical control data enhances interpretation of laboratory dose-response experiments.
  • Established methods like the beta-binomial score test exist for carcinogenicity studies.
  • Existing methods fail for developmental toxicity due to litter effects (correlated data).

Purpose of the Study:

  • To develop a statistical trend test for developmental toxicity studies.
  • To incorporate historical control information into the analysis.
  • To address correlated binary outcomes arising from litter effects.

Main Methods:

  • Utilized quasi-likelihood methods to integrate historical control data.
  • Developed a trend test specifically for correlated binary outcomes in developmental toxicity.

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  • Compared the proposed test to existing methods, noting asymptotic equivalence under specific conditions.

    • Main Results:

    • The proposed quasi-likelihood trend test effectively incorporates historical control data.
    • The method accounts for the litter effect correlation structure inherent in developmental toxicity studies.
    • The test is asymptotically equivalent to the beta-binomial score test when litter sizes are uniform (n=1).

    Conclusions:

    • Quasi-likelihood methods provide a robust approach for analyzing developmental toxicity data with historical controls.
    • The new trend test offers a statistically sound alternative for evaluating dose-response relationships in developmental toxicology.
    • This methodology improves the utilization of historical data in regulatory toxicology assessments.