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Related Experiment Videos

An age-adjusted bootstrap-based Poly-k test.

Hojin Moon1, Hongshik Ahn, Ralph L Kodell

  • 1Division of Biometry and Risk Assessment, National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Drive, Jefferson, AR 72079, USA. hmoon@nctr.fad.gov

Statistics in Medicine
|December 2, 2004
PubMed
Summary
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A new age-adjusted bootstrap method improves dose-response trend tests for carcinogenicity studies when asymptotic normality assumptions fail. This method preserves mortality rates, offering a more robust assessment of tumor incidence trends.

Area of Science:

  • Toxicology
  • Biostatistics
  • Cancer Research

Background:

  • Standard dose-response trend tests in carcinogenicity studies often assume asymptotic normality.
  • This assumption can be violated by deviations in tumor onset distributions or differing survival rates due to competing risks.
  • The survival-adjusted Cochran-Armitage test (Poly-k) is one such test where asymptotic normality may not hold.

Purpose of the Study:

  • To develop and evaluate an age-adjusted bootstrap-based method for assessing the significance of dose-response trend tests.
  • To address the limitations of asymptotic normality assumptions in animal carcinogenicity data.
  • To compare the proposed method with traditional approaches using the Poly-3 (P3) trend test statistic.

Main Methods:

  • An age-adjusted bootstrap-based method was developed, specifically designed to preserve mortality rates within dose groups under the null hypothesis.

Related Experiment Videos

  • The empirical distribution of the Poly-3 (P3) trend test statistic was investigated using the proposed bootstrap method.
  • A simulation study evaluated the robustness of the method against various Weibull-family tumor onset distributions.

    • Main Results:

    • The proposed age-adjusted bootstrap method provides a more accurate assessment of trend test statistics compared to relying solely on assumed standard normal distributions.
    • The method demonstrated robustness across different tumor onset distributions.
    • Application to National Toxicology Program data confirmed its utility in evaluating dose-related trends of test substances on neoplasm incidence.

    Conclusions:

    • The developed age-adjusted bootstrap method offers a reliable alternative for significance testing in dose-response studies when asymptotic normality is questionable.
    • This approach enhances the accuracy of carcinogenicity assessments, particularly when dealing with complex survival data.
    • The method is valuable for analyzing animal carcinogenicity data and evaluating chemical exposures.